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Showing 857 of 857 tracked regulatory updates from 32 agencies.

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ClinicalTrials.govGlobal1d agoPreventive Role of Melatonin and Propranolol Administration in Pediatric MigraineNA | ENROLLING_BY_INVITATION | Nishtar Medical University | Melatonin | PropranololClinicalTrials.gov ClinicalTrials.govGlobal1d agoIris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia PatientsPhase 4 | NOT_YET_RECRUITING | Mohsen Pourazizi | tamsulosin 0.4mg | Silodosin 8 mgClinicalTrials.gov ClinicalTrials.govGlobal1d agoPhase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK201 for Injection in Combination With Ivonescimab Injection in sqNSCLC Participants.Phase 2 | NOT_YET_RECRUITING | Shanghai Allink Biotherapeutics Co., Ltd. | ALK201 for injection | Ivonescimab InjectionClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Clinical Trial to Evaluate the Effects of a Supplement on Cognitive PerformanceNA | COMPLETED | Xula Wellness LLCClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Soft Tissue SarcomaPhase 2 | NOT_YET_RECRUITING | Iovance Biotherapeutics, Inc. | LifileucelClinicalTrials.gov ClinicalTrials.govGlobal1d agoLow Power HOLEP Versus TURPNA | ENROLLING_BY_INVITATION | Al-Azhar UniversityClinicalTrials.gov ClinicalTrials.govGlobal1d agoBiomarker Analysis Data From a Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma Treated With Chemotherapy and RadiotherapyN/A | COMPLETED | Hellenic Cooperative Oncology GroupClinicalTrials.gov ClinicalTrials.govGlobal1d agoPrediction Model of Spontaneous Closure of Congenital Perimembranous Ventricular Septal DefectsN/A | WITHDRAWN | Xinhua Hospital, Shanghai Jiao Tong University School of MedicineClinicalTrials.gov ClinicalTrials.govGlobal1d agoThis Study Aims to Evaluate the Safety and Efficacy of Fiber Supplementation on Constipation in Neurologically Impaired Children Using Rectal Wall Thickness Measurement by Ultrasound.NA | ACTIVE_NOT_RECRUITING | Ain Shams UniversityClinicalTrials.gov ClinicalTrials.govGlobal1d agoPharmacodynamic Evaluation of OV329 in Participants with Epilepsy and a Photo-Induced Generalized Epileptiform EEG-Response Phase 2 Proof-of-Concept.Therapeutic exploratory (Phase II) | Authorised, recruitment pending | Ovid Therapeutics Inc. | OV329 | Placebo for OV329ClinicalTrials.gov ClinicalTrials.govGlobal1d agoNon-inferiority of surgical treatment of cartilage defects of the knee with autologous minced cartilage implantation (AMCI) and matrix-asscociated autologous chondrocyte implantation with respect to KOOS at 24 months (M ACI) - MinCaRCTTherapeutic use (Phase IV) | Authorised, recruitment pending | Medical Center - University Of Freiburg | MACI 500 | 000 to 1 | 000ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative ColitisTherapeutic confirmatory (Phase III) | Authorised, recruitment pending | Janssen Cilag International | JNJ-78934804 | GuselkumabClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s DiseaseTherapeutic confirmatory (Phase III) | Authorised, recruitment pending | Janssen Cilag International | JNJ-78934804 | GuselkumabClinicalTrials.gov ClinicalTrials.govGlobal1d agoA First-in-Human Study of INCA035784 in Participants With Myeloproliferative NeoplasmsHuman Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | Incyte Corp.ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared with Elecoglipron Alone and Dapagliflozin Alone, in Adults with Type 2 Diabetes Mellitus (Eluminate-5)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | AstraZeneca AB | Elecoglipron | Placebo for Elecoglipron (AZD5004) | Forxiga 10 mg film-coated tabletsClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron compared with Placebo in Adults with Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin (Eluminate-4)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | AstraZeneca AB | Elecoglipron | Forxiga 10 mg film-coated tablets | Placebo for Elecoglipron (AZD5004)ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. | Placebo matching in size | weight | colourClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive ChemotherapyPhase II and Phase III (Integrated) | Authorised, recruitment pending | AbbVie Deutschland GmbH & Co. KG | Venetoclax | PIVEKIMAB SUNIRINE | AZACITIDINEClinicalTrials.gov ClinicalTrials.govGlobal1d agoFeasibility clinical trial of the sequential combination of AloCelyvir and activated tumor-infiltrating lymphocytes (TILs) for the treatment of children and young adults with advanced neuroblastomaHuman Pharmacology (Phase I)- First administration to humans | Not authorised | Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa | Autologous tumor-infiltrating T lymphocytes | ex vivo expanded with interleukin-7 | interleukin-15 and interleukin-21ClinicalTrials.gov ClinicalTrials.govGlobal1d agoRUBY study « Randomized controlled trial testing the efficacy of corticosteroid therapy versus placebo in fibrotic hypersensitivity pneumonitis.»Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Assistance Publique Hopitaux De Paris | SOLUPRED 5 mg | comprimé orodispersible | solupred 5mg placeboClinicalTrials.gov ClinicalTrials.govGlobal1d agoTreatment of patients with autoantibody-positive autoimmune diseases and severe interstitial lung fibrosis with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector - a single center Phase I/II clinical trial (HD-CAR-ILD-1)Human Pharmacology (Phase I)- Other | Authorised, recruitment pending | Universitaetsklinikum Heidelberg AöR | CD19.CAR T cellsClinicalTrials.gov ClinicalTrials.govGlobal1d agoRole of ERBT Plus Intravesical BCG in Intermediate-Risk or High-Risk NMBCNA | NOT_YET_RECRUITING | Chinese University of Hong KongClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1982 to Prevent Lyme Disease in Healthy Participants (18 to 70 Years of Age)Phase 2 | ACTIVE_NOT_RECRUITING | ModernaTX, Inc. | mRNA-1982 | PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d agoTofacitinib Plus Imatinib in Moderate-to-Severe Palmoplantar PustulosisPhase 3 | NOT_YET_RECRUITING | Second Affiliated Hospital, School of Medicine, Zhejiang University | Tofacitinib | Imatinib | tofacitinib PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d agoEvaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesNA | RECRUITING | Insulet CorporationClinicalTrials.gov ClinicalTrials.govGlobal1d agoCharacterization of the Natural History of Microduplication Syndrome 7q11.23NA | RECRUITING | Hospices Civils de LyonClinicalTrials.gov ClinicalTrials.govGlobal1d agoEffects of Butylphthalide Enhanced With Tenecteplase on Neurological Function in Mild Disabling Acute Ischemic StrokePhase 3 | RECRUITING | Xiangya Hospital of Central South University | Combination Group | Control GroupClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study of Orelabrutinib in Patients With Secondary Progressive Multiple SclerosisPhase 3 | RECRUITING | Zenas BioPharma (USA), LLC | Orelabrutinib | PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d agoEncouraging Older Adults and Adults With Serious Illness to Designate a Health Care ProxyNA | ENROLLING_BY_INVITATION | University of Southern CaliforniaClinicalTrials.gov ClinicalTrials.govGlobal1d agoTest-retest Study With [18F]FBB in Cardiac AmyloidosisPhase 1 | RECRUITING | Lantheus Germany GmbH | Florbetaben F18ClinicalTrials.gov ClinicalTrials.govGlobal1d agoA Study on the Immunogenicity and Safety of 3 Different Dose Concentrations of a Respiratory Syncytial Virus Vaccine in Infants and ToddlersPhase 3 | TERMINATED | Sanofi Pasteur, a Sanofi Company | Low Dose (LD) RSVt vaccine | Standard Dose (SD) RSVt vaccine | High Dose (HD) RSVt vaccineClinicalTrials.gov ClinicalTrials.govGlobal1d agoAn Open-label, Multidose Dose-escalation Study to Understand the Safety of CRISPR Gene-editing Therapy and Its Long-Lasting Effects in DMD Patients (MUSCLE)EARLY/Phase 1 | ACTIVE_NOT_RECRUITING | HuidaGene Therapeutics Co., Ltd.ClinicalTrials.gov ClinicalTrials.govGlobal1d agoStudy of WAL0921 in Patients With Glomerular Kidney DiseasesPhase 2 | RECRUITING | Walden Biosciences | WAL0921 | PlaceboClinicalTrials.gov ClinicalTrials.govGlobal1d agoSpironolactone in Alcohol Use Disorder (SAUD)Phase 1 | RECRUITING | National Institute on Drug Abuse (NIDA) | SpironolactoneClinicalTrials.gov ClinicalTrials.govGlobal1d agoTelerehabilitation Intervention for Individuals With Shoulder PainNA | COMPLETED | Universidade Federal de Sao CarlosClinicalTrials.gov ClinicalTrials.govGlobal1d agoAdvanced Functional and Structural MRI Techniques for Neuropharmacological ImagingNA | RECRUITING | National Institute on Drug Abuse (NIDA)ClinicalTrials.gov ClinicalTrials.govGlobal1d agoStudy of Systemic Lupus ErythematosusN/A | RECRUITING | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)ClinicalTrials.gov ClinicalTrials.govGlobal2d agoA Phase I Study to Evaluate ELA822Human Pharmacology (Phase I)- First administration to humans | Authorised, recruitment pending | Electra Therapeutics Inc.ClinicalTrials.gov ClinicalTrials.govGlobal3d agoBotulinum toxin A in the Treatment of Chronic Postsurgical Pain in Lung Cancer Patients: A feasibility studyTherapeutic exploratory (Phase II) | Authorised, recruitment pending | Aalborg University Hospital | Xeomin | pulver til injektionsvæske | opløsning 100 enhederClinicalTrials.gov ClinicalTrials.govGlobal3d agoThe Danish Anorexia Nervosa Psilocybin RCT (DANP-RCT). A Randomised, Active-Placebo-Controlled, Triple-blind, Superiority Study of Psilocybin-Assisted Acceptance and Commitment Therapy (ACT) in the Treatment of Treatment-resistant Anorexia Nervosa.Therapeutic exploratory (Phase II) | Authorised, recruitment pending | Slagelse Hospital | PEX010ClinicalTrials.gov FDAUnited States6d agoMETFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE | ANDA | AP | SUN PHARM INDUSTRIESFDA FDAUnited States6d agoMYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUM | ANDA | AP | ALKEM LABS LTDFDA FDAUnited States6d agoMYCOPHENOLATE MOFETIL HYDROCHLORIDEMYCOPHENOLATE MOFETIL HYDROCHLORIDE | ANDA | AP | RISINGFDA FDAUnited States6d agoQLONILIKCLONIDINE HYDROCHLORIDE | NDA | AP | CMP DEV LLCFDA FDAUnited States6d agoCICLOPIROXCICLOPIROX | ANDA | AP | SUN PHARMA CANADAFDA FDAUnited States6d agoMYCOPHENOLATE MOFETIL HYDROCHLORIDEMYCOPHENOLATE MOFETIL HYDROCHLORIDE | ANDA | AP | AMNEALFDA FDAUnited States6d agoMYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUM | ANDA | AP | AUROBINDO PHARMA LTDFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | VISTAPHARM LLCFDA FDAUnited States6d agoCELLCEPTMYCOPHENOLATE MOFETIL | NDA | AP | ROCHE PALOFDA FDAUnited States6d agoCELLCEPTMYCOPHENOLATE MOFETIL | NDA | AP | ROCHE PALOFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | SANDOZFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | RISINGFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | CONCORD BIOTECH LTDFDA FDAUnited States6d agoCYTARABINECYTARABINE | ANDA | AP | HOSPIRAFDA FDAUnited States6d agoMYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUM | ANDA | AP | ACCORD HLTHCAREFDA FDAUnited States6d agoMYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUM | ANDA | AP | YICHANG HUMANWELLFDA FDAUnited States6d agoVEKLURYREMDESIVIR | NDA | AP | GILEAD SCIENCES INCFDA FDAUnited States6d agoMYHIBBINMYCOPHENOLATE MOFETIL | NDA | AP | AZURITYFDA FDAUnited States6d agoCELLCEPTMYCOPHENOLATE MOFETIL HYDROCHLORIDE | NDA | AP | ROCHE PALOFDA FDAUnited States6d agoMYCOPHENOLATE SODIUMMYCOPHENOLATE SODIUM | ANDA | AP | APOTEX INCFDA FDAUnited States6d agoMYCOPHENOLATE MOFETIL HYDROCHLORIDEMYCOPHENOLATE MOFETIL HYDROCHLORIDE | ANDA | AP | MEITHEALFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | HIKMAFDA FDAUnited States6d agoCELLCEPTMYCOPHENOLATE MOFETIL | NDA | AP | ROCHE PALOFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | HIKMAFDA FDAUnited States6d agoCAVHANZANILOTINIB | NDA | AP | FLEX PHARMAFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | ACCORD HLTHCAREFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | AUROBINDO PHARMA LTDFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | ZHEJIANG HISUN PHARMFDA FDAUnited States6d agoMYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETIL | ANDA | AP | ZHEJIANG HISUN PHARMFDA FDAUnited States6d agoMYCOPHENOLATE MOFETIL HYDROCHLORIDEMYCOPHENOLATE MOFETIL HYDROCHLORIDE | ANDA | AP | ZYDUS PHARMSFDA MHRAUnited Kingdom14h agoDecision: Human medicines: register of electronic export certificatesMHRA UK MHRAUnited Kingdom14h agoDecision: Marketing authorisations Granted in 2026MHRA UK MHRAUnited Kingdom14h agoDecision: Parallel import licences granted in 2026MHRA UK MHRAUnited Kingdom15h agoNotifiable diseases: causative agents reports for 2026UK Health Security Agency MHRAUnited Kingdom21h agoPneumococcal polysaccharide conjugate vaccine (PCV20) PGD templateUK Health Security Agency MHRAUnited Kingdom21h agoPCV (13-valent or 15-valent, adsorbed): patient group direction (PGD) templateUK Health Security Agency MHRAUnited Kingdom21h agoDHSC privacy noticeUK Department of Health and Social Care MHRAUnited Kingdom21h agoDepartment of Health and Social Care record of processing activity (RoPA)UK Department of Health and Social Care MHRAUnited Kingdom21h agoBCG Vaccine AJV: patient group direction (PGD) templateUK Health Security Agency MHRAUnited Kingdom1d agoUKHSA updates heat health alerts across EnglandUK Health Security Agency MHRAUnited Kingdom3d agoImmunoglobulin: when to useUK Health Security Agency MHRAUnited Kingdom3d agoUK Clinical Research Delivery key performance indicators: data to August 2026UK Department of Health and Social Care MHRAUnited Kingdom3d agoMalaria prevention guidelines for travellers from the UK 2026UK Health Security Agency MHRAUnited Kingdom3d agoGovernment takes action to crack down on rogue funeral operatorsUK Department of Health and Social Care MHRAUnited Kingdom3d agoChildhood vaccination coverage: provisional monthly data for EnglandUK Health Security Agency MHRAUnited Kingdom3d ago2024 VPAG operational review minutesUK Department of Health and Social Care MHRAUnited Kingdom3d ago2024 VPAG operational review: 12 August 2025UK Department of Health and Social Care MHRAUnited Kingdom3d agoDecision: Medical devices given exceptional use authorisationsMHRA UK MHRAUnited Kingdom3d agoThe national gonorrhoea vaccination programme using 4CMenB vaccine: frequently asked questionsUK Health Security Agency MHRAUnited Kingdom3d agoClinical trials for medicines: MHRA phase I accreditation schemeMHRA UK MHRAUnited Kingdom3d agoMeasures from the adult social care outcomes framework, England: 2025 to 2026UK Department of Health and Social Care MHRAUnited Kingdom3d agoSafeguarding adults, England: 2025 to 2026 reportUK Department of Health and Social Care MHRAUnited Kingdom3d agoDeferred payment agreements, England: 2025 to 2026 reportUK Department of Health and Social Care MHRAUnited Kingdom3d agoAdult social care survey, England: 2025 to 2026 reportUK Department of Health and Social Care MHRAUnited Kingdom3d agoHealthy child programmeUK Department of Health and Social Care MHRAUnited Kingdom3d agoCare continuity between midwifery and health visiting servicesUK Department of Health and Social Care MHRAUnited Kingdom3d agoUnlocking the East of England’s life sciences potential: Reflections from our regional roundtableABPI UK MHRAUnited Kingdom3d agoDHSC spending over £500UK Department of Health and Social Care MHRAUnited Kingdom3d agoDHSC: spending over £500, June 2026UK Department of Health and Social Care MHRAUnited Kingdom4d agoEbola and Marburg haemorrhagic fevers: outbreaks and case locationsUK Health Security Agency MHRAUnited Kingdom4d agoOutbreaks under monitoring in 2026UK Health Security Agency MHRAUnited Kingdom4d agoHealth Protection Report volume 20 (2026)UK Health Security Agency MHRAUnited Kingdom4d agoNational partnership agreement on asylum seeker health in EnglandUK Health Security Agency MHRAUnited Kingdom4d agoNHS and industry join forces on next generation of hospitalsUK Department of Health and Social Care MHRAUnited Kingdom4d agoMHRA Safety Roundup: July 2026MHRA UK MHRAUnited Kingdom4d agoWeekly all-cause mortality surveillance: 2026 to 2027UK Health Security Agency MHRAUnited Kingdom4d agoNational flu and COVID-19 surveillance reports: 2026 to 2027 seasonUK Health Security Agency MHRAUnited Kingdom4d agoNational flu and COVID-19 surveillance reports: 2025 to 2026 seasonUK Health Security Agency MHRAUnited Kingdom4d agoSyndromic surveillance: weekly summaries for 2026UK Health Security Agency MHRAUnited Kingdom4d agoRemote health advice: weekly bulletins for 2026UK Health Security Agency MHRAUnited Kingdom4d agoNational measles guidelinesUK Health Security Agency MHRAUnited Kingdom4d agoNational ambulance syndromic surveillance: weekly bulletins 2026UK Health Security Agency MHRAUnited Kingdom4d agoGP out-of-hours syndromic surveillance: weekly bulletins for 2026UK Health Security Agency MHRAUnited Kingdom4d agoGP in-hours: weekly bulletins for 2026UK Health Security Agency MHRAUnited Kingdom4d agoEmergency department: weekly bulletins for 2026UK Health Security Agency MHRAUnited Kingdom4d agoCalls for collaboration on medical research in WalesABPI UK MHRAUnited Kingdom4d agoMERS-CoV: self-isolating awaiting MERS-CoV test resultUK Health Security Agency MHRAUnited Kingdom4d agoGuidance: Magnetic resonance imaging equipment in clinical use: safety guidelinesMHRA UK MHRAUnited Kingdom4d agoLegionnaires' disease: national surveillance schemeUK Health Security Agency MHRAUnited Kingdom4d agoSharp rise in cyclospora infections linked to Mexico travelUK Health Security Agency MHRAUnited Kingdom4d agoThousands of patients to benefit from new daily pill for serious heart condition following co-ordinated MHRA and NICE decisionsMHRA UK MHRAUnited Kingdom4d agoPioneering AI health innovations regulatory sandbox launchedMHRA UK MHRAUnited Kingdom4d agoUKHSA report shows 2,877 excess deaths caused by May and June heatwavesUK Health Security Agency MHRAUnited Kingdom4d agoRespiratory syncytial virus (RSV): vaccination for older adultsUK Health Security Agency MHRAUnited Kingdom4d agoUsing the professional title ‘nurse’UK Department of Health and Social Care MHRAUnited Kingdom4d agoRespiratory syncytial virus (RSV) vaccination programmeUK Health Security Agency MHRAUnited Kingdom4d agoEnvironmental monitoring following the Grenfell Tower fireUK Health Security Agency MHRAUnited Kingdom4d agoNational norovirus and rotavirus surveillance reports: 2026 to 2027 seasonUK Health Security Agency MHRAUnited Kingdom4d agoUKHSA ad hoc statistical publicationsUK Health Security Agency MHRAUnited Kingdom4d agoInterim heat mortality monitoring report, England: May and June 2026UK Health Security Agency EOF GreeceGreece17h agoΣυμπερίληψη Ελλάδας στον κατάλογο χωρών αναφοράς του Αιγυπτιακού Οργανισμού Φαρμάκων.EOF Greece EOF GreeceGreece3d agoΑπαγόρευση κυκλοφορίας του προϊόντος TEMPUFEN της εταιρείας ANTALIA PHARMA ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε.EOF Greece EOF GreeceGreece4d agoΑνάκληση της παρτίδας 150426 του Καλλυντικού προϊόντος Lolota Professional nails UV& UV LED GEL POLISH 46EOF Greece EOF GreeceGreece5d agoΑνάκληση της παρτίδας V0281, του φαρμακευτικού προϊόντος FAMPRIDIN-NEURAXPHARM 10MGEOF Greece EOF GreeceGreece6d agoΝέα ΣΥΦΑ 2ου Τριμήνου 2026 _ Τιμολόγηση Φαρμακευτικών Προϊόντων (τελ.ενημ. 30-7-2026)EOF Greece EOF GreeceGreece6d agoΤιμολόγηση Νέων _ Τελικά Προϊόντα Φαρμακευτικής Κάνναβης _ Προτεινόμενες Τιμές προς ΔιαβούλευσηEOF Greece EOF GreeceGreece6d agoΕΠΙΚΟΙΝΩΝΙΑ ΓΙΑ ΕΛΛΕΙΨΗ ΦΑΡΜΑΚΕΥΤΙΚΟΥ ΠΡΟΪΟΝΤΟΣ ΤEGSEDIEOF Greece EOF GreeceGreeceJul 27Γενόσημα Μαΐου 2026 _ Προτεινόμενες Τιμές προς ΔιαβούλευσηEOF Greece EOF GreeceGreeceJul 22Σχετικά με την προσφορά οικονομικών παροχών σε συμμετέχοντες σε κλινικές δοκιμές με φάρμακα, κλινικές έρευνες με ιατροτεχνολογικά προϊόντα και μελέτες επιδόσεων με in vitro διαγνωστικά προϊόνταEOF Greece EOF GreeceGreeceJul 22Εκτέλεση προϋπολογισμού ΕΟΦ μηνός Ιουνίου 2026EOF Greece EOF GreeceGreeceJul 22Ανάκληση της παρτίδας 2500143F, του φαρμακευτικού προϊόντος BENTALYA VIAL 5×25 MG/10MLEOF Greece EOF GreeceGreeceJul 22Ανάκληση των παρτίδων του παρακάτω πίνακα του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIb, OverStritch Suture Cinch and Sature Cinch-Long, (Εξάρτημα ασφάλισης ράμματος και εξάρτημα ασφάλισης ράμματος μεγάλου μήκους)EOF Greece EOF GreeceGreeceJul 22Επίσημη επίσκεψη της Διοίκησης του Εθνικού Οργανισμού Φαρμάκων (ΕΟΦ) στην Κυπριακή Δημοκρατία για την ενίσχυση της συνεργασίας στον τομέα του ρυθμιστικού πλαισίου των φαρμάκωνEOF Greece EOF GreeceGreeceJul 20Παροχές εταιρειών προϊόντων αρμοδιότητας ΕΟΦ έτους 2025 δυνάμει της παραγράφου 7 του άρθρου 66 του Ν. 4316/2014 (Α΄ 270)EOF Greece EOF GreeceGreeceJul 20Ανάκληση της Άδειας Χονδρικής πώλησης φαρμάκων για Ανθρώπινη Χρήση στο πρατήριο της εταιρείας DEKAZ ΑΕEOF Greece EOF GreeceGreeceJul 20Ανάκληση της παρτίδας 202412 του Καλλυντικού προϊόντος ALOHA Nails & Cosmetics REPAIR GEL MILKY LILAC, λόγω παρουσίας TPOEOF Greece EOF GreeceGreeceJul 20Ανάκληση της παρτίδας 272955 του Ιατροτεχνολογικού προϊόντος κατηγορίας IVD General, Kits STA- C.K. Prest.EOF Greece EOF GreeceGreeceJul 20Απόφαση απαγόρευσης διακίνησης και διάθεσης – 92890 Cotton absorbent gauze (REF: 6-1003Ν2 & REF: 6-1006Ν2)EOF Greece EOF GreeceGreeceJul 16Tavneos (avacopan): Απευθείας επικοινωνία προς επαγγελματίες υγείαςEOF Greece EOF GreeceGreeceJul 16ΜΗΣΥΦΑ 1ου Τριμήνου 2026 _ Προτεινόμενες Τιμές προς ΔιαβούλευσηEOF Greece EOF GreeceGreeceJul 16Δήλωση Αποθεμάτων Φαρμάκων Ανθρώπινης ΧρήσηςEOF Greece EOF GreeceGreeceJul 15Κύρια σημεία συνεδρίασης της Επιτροπής Αξιολόγησης Κινδύνου Φαρμακοεπαγρύπνησης (PRAC), 6 – 9 Ιουλίου 2026EOF Greece EOF GreeceGreeceJul 15Ανάκληση του κτηνιατρικού προϊόντος MODULIS 100 MG/ML ORAL SOLUTION FOR DOGS, με αρ. παρτίδων 8Β1 και 10Β1EOF Greece EOF GreeceGreeceJul 13Ανατιμολόγηση ΜΗΣΥΦΑ 2026 _ Προτεινόμενες τιμές προς διαβούλευσηEOF Greece EOF GreeceGreeceJul 10Ανάκληση παρτίδων του ιατροτεχνολογικού προϊόντος αντιδραστηρίου ‘CHORUS Ttg-G’EOF Greece EOF GreeceGreeceJul 10Πρόσκληση Εκδήλωσης Ενδιαφέροντος για σύσταση και στελέχωση της Επιτροπής Ελέγχου του Εθνικού Οργανισμού Φαρμάκων.EOF Greece EOF GreeceGreeceJul 10Ανάκληση παρτίδων των Ιατροτεχνολογικών προϊόντων κατηγορίας MDD Class III, ραμμάτων Surgipro, Surgipro II, Dermalon, V-Loc 90 και V-Loc 180EOF Greece EOF GreeceGreeceJul 10Γενόσημα Απριλίου 2026_Τελικές Προτεινόμενες ΤιμέςEOF Greece EOF GreeceGreeceJul 10ΑΝΑΚΟΙΝΩΣΗ – ΔΙΑΚΟΠΗ ΗΛΕΚΤΡΟΝΙΚΩΝ ΥΠΗΡΕΣΙΩΝEOF Greece EOF GreeceGreeceJul 9ΑΝΑΡΤΗΣΗ ΛΙΣΤΑ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΣΚΕΥΑΣΜΑΤΩΝ ΠΕΡΙΟΡΙΣΜΕΝΗΣ ΔΙΑΘΕΣΙΜΟΤΗΤΑΣ 30 ΙΟΥΝΙΟΥ 2026EOF Greece EOF GreeceGreeceJul 9Επαναδιατύπωση και Ανάρτηση Πρόσκλησης Εκδήλωσης Ενδιαφέροντος για Συνεργασία με Καθεστώς Α.Π.Υ. (Ορθή Επανάληψη)EOF Greece EOF GreeceGreeceJul 8EREXON INTENSE BLUE και VIGUEUR CAPSULE (ΣΙΛΔΕΝΑΦΙΛΗ, ΤΑΔΑΛΑΦΙΛΗ, BΑΡΔΕΝΑΦΙΛΗ)EOF Greece EOF GreeceGreeceJul 8Ανάκληση της παρτίδας GR23193050 του καλλυντικού προϊόντος βερνίκι νυχιών MARTINELLA CRUSH NAIL POLISH 2 X 4mlEOF Greece EOF GreeceGreeceJul 8Ανάκληση παρτίδων του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIa, THERAKOS CELLEX Photopheresis Procedural KitEOF Greece EOF GreeceGreeceJul 8ΕΝΗΜΕΡΩΣΗ ΣΧΕΤΙΚΑ ΜΕ ΤΗΝ ΜΗ ΝΟΜΙΜΗ ΠΑΡΟΥΣΙΑΣΗ, ΠΡΟΩΘΗΣΗ ΚΑΙ ΧΟΡΗΓΗΣΗ «ΕΝΔΟΦΛΕΒΙΩΝ ΘΕΡΑΠΕΙΩΝ»ΩΣ ΣΥΜΠΛΗΡΩΜΑΤΩΝ ΔΙΑΤΡΟΦΗΣEOF Greece EOF GreeceGreeceJul 8Ανάκληση παρτίδων του Ιατροτεχνολογικού προϊόντος Rapid Refill Continuous Injection SystemEOF Greece EOF GreeceGreeceJul 8Τελικές Προτεινόμενες _ Νέα 1ου Τριμήνου 2026 _ Ανατιμολόγηση προϊόντων αναφοράς λόγω λήξης της προστασίας δεδομένων τουςEOF Greece EOF GreeceGreeceJul 7Επιστημονικές εκδηλώσεις εσωτερικού Α΄ εξαμήνου 2026EOF Greece EOF GreeceGreeceJul 3Γενόσημα Απριλίου 2026 _ Προτεινόμενες Τιμές προς ΔιαβούλευσηEOF Greece EOF GreeceGreeceJul 3ERKEXIN / (ΣΙΛΔΕΝΑΦΙΛΗ, ΤΑΛΑΔΑΦΙΛΗ)EOF Greece EOF GreeceGreeceJul 3Ανάκληση των παρτίδων του παρακάτω πίνακα, του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIa, Αρτηριακές κάνουλες ΕΟΡΑEOF Greece EOF GreeceGreeceJul 3Ανάκληση των σειριακών αριθμών 109980699 και 110143347 του κωδικού 1739994, του Ιατροτεχνολογικού προϊόντος MDD Class I, Adapter for Head positioning (εξάρτημα προσαρμογής για τοποθέτηση κεφαλής).EOF Greece EOF GreeceGreeceJul 2ΠΡΟΚΗΡΥΞΗ ΠΛΗΡΩΣΗΣ ΘΕΣΕΩΝEOF Greece EOF GreeceGreeceJul 2Ανάκληση από την αγορά των προϊόντων με Device name: «Non-sterile folded gauze», της κατασκευάστριας εταιρείας YANCHENG ZAICHUANG MEDICAL SUPPLIES CO LTD (Κίνας) (Εξουσ. Αντιπρ. για την Ε.Ε. MedPath GmbH (Γερμανία)), τα οποία συνοδεύονται από παραποιημένη δήλωση συμμόρφωσης του κατασκευαστή.EOF Greece EOF GreeceGreeceJun 29Ανάκληση των παρτίδων του παρακάτω πίνακα του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIΙ, HYBRID GuidewireEOF Greece EOF GreeceGreeceJun 26TURBO 69 (ΣΤΑΓΟΝΕΣ) / (ΣΙΛΔΕΝΑΦΙΛΗ)EOF Greece EOF GreeceGreeceJun 26ΟΡΘΗ-Ανάκληση της παρτίδας 241105VIY, ημ λήξης: 10/2027, (REF: PGA30F0126), του ιατροτεχνολογικού προϊόντος ΧΕΙΡΟΥΡΓΙΚΑ ΡΑΜΜΑΤΑ RT MED Πολύκλωνο Συνθετικό Απορροφήσιμο Πλεκτό Ράμμα – Βιολετί, 75CM, USP 3/0, EP METRIC 1/2 κύκλου, στρογγυλή βελόνη 26 χιλEOF Greece EOF GreeceGreeceJun 26Ανάκληση της παρτίδας 240592, του καλλυντικού προϊόντος Perfume Mall WOMEN’S EAU DE PERFUMEEOF Greece EOF GreeceGreeceJun 26Ανάκληση της παρτίδας 21393A07C, του καλλυντικού προϊόντος Tesori d’ Oriente Fior di Loto Aromatic Perfume 100mlEOF Greece EOF GreeceGreeceJun 26Ανάκληση παρτίδας του προϊόντος MANUSHIELD CLEANEREOF Greece EOF GreeceGreeceJun 26Απαγόρευση διάθεσης και διακίνησης του συμπληρώματος διατροφής NOW ZINC GLUCONATE 50MG, 250 TABSEOF Greece EOF GreeceGreeceJun 26Απαγόρευση διάθεσης και διακίνησης των συμπληρωμάτων διατροφής Hiro.Lab Tongkat Ali 400MG, Hiro.Lab Turkesterone 600mgEOF Greece EOF GreeceGreeceJun 26Τιμολόγηση Νέων Φαρμακευτικών Προϊόντων_Νέα 1ου Τριμήνου 2026_Ανατιμολόγηση προϊόντων αναφοράς λόγω λήξης της προστασίας δεδομένων τους_Εξέταση αιτημάτων αναπροσαρμογής τιμής μη αποζημιούμενων σκευασμάτωνEOF Greece EOF GreeceGreeceJun 25ΠΙΛΟΤΙΚΟ ΠΡΟΓΡΑΜΜΑ ΗΛΕΚΤΡΟΝΙΚΗΣ ΕΚΔΟΣΗΣ ΦΥΛΛΟΥ ΟΔΗΓΙΩΝ ΧΡΗΣΗΣ, ΦΑΡΜΑΚΩΝ ΑΝΘΡΩΠΙΝΗΣ ΧΡΗΣΗΣEOF Greece EOF GreeceGreeceJun 24(τελευταία ενημέρωση 25/6)ΑΝΑΚΟΙΝΩΣΗ – ΔΙΑΚΟΠΗ ΗΛΕΚΤΡΟΝΙΚΩΝ ΥΠΗΡΕΣΙΩΝEOF Greece EOF GreeceGreeceJun 23Ανάκληση των αχρησιμοποίητων παρτίδων του παρακάτω πίνακα του Ιατροτεχνολογικού προϊόντος κατηγορίας AIMD Active implants, SCS Infinion CX Lead (Κιτ απαγωγής Infinion CX)EOF Greece EOF GreeceGreeceJun 22RENEWAL OF VMPs 2026EOF Greece EOF GreeceGreeceJun 22ΑΝΑΝΕΩΣΕΙΣ ΚΤΗΝΙΑΤΡΙΚΩΝ ΠΡΟΪΟΝΤΩΝ 2026EOF Greece EOF GreeceGreeceJun 19Δήλωση Αποθεμάτων Φαρμάκων Ανθρώπινης ΧρήσηςEOF Greece EOF GreeceGreeceJun 19ΑΝΑΚΟΙΝΩΣΗ ΣΧΕΤΙΚΑ ΜΕ ΔΙΟΡΘΩΤΙΚΟ 2025/90805 ΣΤΟΝ ΚΑΝΟΝΙΣΜΟ 1223/2009EOF Greece AEMPSSpain19h agoBoletín sobre Seguridad de Medicamentos de Uso Humano. Junio de 2026AEMPS (Spain)AEMPSSpain1d agoLa AEMPS colabora con la agencia reguladora de Ghana para fortalecer sus capacidades para la evaluación de medicamentos biológicosAEMPS (Spain)AEMPSSpain3d agoLa AEMPS informa sobre la restricción de microplásticos y sus implicaciones para los productos biocidas de su competenciaAEMPS (Spain)AEMPSSpain4d agoEspaña, país pionero en la Unión Europea en la supresión del prospecto en papel en medicamentos de ámbito hospitalarioAEMPS (Spain)AEMPSSpain5d agoLa AEMPS concede los V Premios PRAN 2026 a nueve iniciativas frente a la resistencia a los antimicrobianosAEMPS (Spain)AEMPSSpain6d agoLa AEMPS valida un modelo de gobernanza y un plan de acción para facilitar la aplicación del reglamento sobre evaluación de tecnologías sanitariasAEMPS (Spain)AEMPSSpain6d agoEl consumo de antibióticos en España retoma la senda de descenso y cae cerca del 19% desde 2015AEMPS (Spain)AEMPSSpainJul 27Boletín sobre Cosméticos, Biocidas AEMPS y Productos de Cuidado Personal. abril-junio 2026AEMPS (Spain)AEMPSSpainJul 27La AEMPS, primera agencia europea que participa en un programa de pasantías internacionales con la Organización Panamericana de la SaludAEMPS (Spain)AEMPSSpainJul 24Reunión del Comité de Medicamentos de Uso Humano de julio de 2026AEMPS (Spain)AEMPSSpainJul 23Boletín sobre Productos Sanitarios. Abril – junio 2026AEMPS (Spain)AEMPSSpainJul 23La AEMPS informa de la detección de unidades falsificadas del producto cosmético Xhekpon cremaAEMPS (Spain)AEMPSSpainJul 23La AEMPS inicia los IPT de los medicamentos que han obtenido una opinión positiva en la reunión del CHMP celebrada en junioAEMPS (Spain)AEMPSSpainJul 23La AEMPS inicia los IPT de los medicamentos que han obtenido una opinión positiva en la reunión del CHMP celebrada en mayoAEMPS (Spain)AEMPSSpainJul 23La AEMPS habilita el procedimiento para realizar la comunicación previa de la fabricación in house de productos sanitarios para diagnóstico in vitroAEMPS (Spain)AEMPSSpainJul 23La AEMPS participa en el proyecto Vac-Med para fortalecer las capacidades regulatorias de América Latina y CaribeAEMPS (Spain)AEMPSSpainJul 22Reunión del Comité de Medicamentos de Uso Humano de junio de 2026AEMPS (Spain)AEMPSSpainJul 22La AEMPS informa de la retirada de equipos para Cicladora Personal HomeChoice con cassette y 4 líneasAEMPS (Spain)AEMPSSpainJul 22La AEMPS y Plena Inclusión Madrid lanzan una guía en lectura fácil para promover una exposición solar seguraAEMPS (Spain)AEMPSSpainJul 22La CE publica unas recomendaciones para identificar cuándo está justificada la prescripción en cascada de medicamentos veterinariosAEMPS (Spain)AEMPSSpainJul 22Boletín sobre Seguridad de Medicamentos de Uso Humano. Mayo de 2026AEMPS (Spain)AEMPSSpainJul 21Boletín del Comité de Medicamentos de Uso Humano. Junio de 2026AEMPS (Spain)AEMPSSpainJul 21Boletín del Comité de Medicamentos de Uso Humano. Mayo de 2026AEMPS (Spain)AEMPSSpainJul 21Boletín sobre Seguridad de Medicamentos de Uso Humano. Abril de 2026AEMPS (Spain)AEMPSSpainJul 21Boletín sobre Medicamentos Veterinarios. Abril- Junio 2026AEMPS (Spain)AEMPSSpainJul 21Reunión del Comité de Medicamentos Veterinarios de julio de 2026AEMPS (Spain)AEMPSSpainJul 21Reunión del Comité de Medicamentos Veterinarios de junio de 2026AEMPS (Spain)AEMPSSpainJul 20La AEMPS publica dos nuevas infografías informativas sobre reconstrucción mamaria y mamoplastia de aumentoAEMPS (Spain)AEMPSSpainJul 20La AEMPS informa de la entrada en aplicación del Reglamento de Ejecución (UE) 2024/1973 sobre el uso de determinados antimicrobianos en animalesAEMPS (Spain)AEMPSSpainJul 17La AEMPS informa de la retirada de un lote del medicamento veterinario Tessie 0,3 mg/ml solución oral para perrosAEMPS (Spain)AEMPSSpainJul 17TESSIE 0,3 MG/ML SOLUCION ORAL PARA PERROS (EU/2/21/276/001)AEMPS Spain AEMPSSpainJul 17La AEMPS informa sobre el nuevo Sistema de Evaluación de Tecnologías Sanitarias tras la aprobación del Real Decreto 415/2026AEMPS Spain AEMPSSpainJul 17La AEMPS informa del robo y distribución ilegal de dos lotes de sensores Dexcom G7AEMPS Spain AEMPSSpainJul 17La AEMPS informa del riesgo de caídas en determinadas grúas Winn’MotionAEMPS Spain AEMPSSpainJul 16La AEMPS informa de un posible fallo en la aplicación MiniMed Go para la diabetes que afecta al funcionamiento de las alertas nocturnasAEMPS Spain AEMPSSpainJul 16La AEMPS informa de la retirada del mercado de determinadas cánulas Guedel de una sola piezaAEMPS Spain AEMPSSpainJul 16La AEMPS informa de la retirada de seis lotes del medicamento veterinario Modulis 100mg/ml solución oral para perrosAEMPS Spain AEMPSSpainJul 16MODULIS 100 MG/ML SOLUCION ORAL PARA PERROS (Nº 3178 ESP)AEMPS Spain AEMPSSpainJul 15Segunda reunión de 2026 del Comité de Seguridad de Medicamentos Veterinarios y del Comité Técnico del Sistema Español de Farmacovigilancia de Medicamentos VeterinariosAEMPS Spain AEMPSSpainJul 15La AEMPS actualiza su Carta de Servicios para el periodo 2026-2029AEMPS Spain AEMPSSpainJul 14La AEMPS informa de que la UE amplía a 81 el número de alérgenos de fragancias que deberán etiquetarse en el listado de ingredientes de cosméticosAEMPS Spain AEMPSSpainJul 14La EMA recomienda retirar la autorización de comercialización de avacopan (Tavneos)AEMPS Spain AEMPSSpainJul 14La AEMPS informa de las nuevas medidas para prevenir el daño hepático con avacopan (Tavneos)AEMPS Spain AEMPSSpainJul 13La AEMPS deja de emitir la comunicación de la decisión para las variaciones IA/IAin en procedimientos europeos en los que actúa como Estado Miembro ConcernidoAEMPS Spain AEMPSSpainJul 9Natac Biotech receives €1.4 Million from the Spanish Ministry of Industry for the FRACTAL Project09/07/2026FinancingThe funding will support the development of a new generation of high-value natural ingredients…Partners - Natac GroupAsebio Spain AEMPSSpainJul 8ORYZON announces U.S. patent grant for vafidemstat in borderline personality disorder (BPD)08/07/2026Healthcare Rare diseases Innovative drugsGranted claims cover the use of vafidemstat for treating non-aggressive symptoms of BPD.Partners - Oryzon GenomicsAsebio Spain AEMPSSpainJul 8La AEMPS informa del cese de comercialización y retirada del mercado de productos para tatuaje y maquillaje permanente de la marca Dynamic Platinum Tattoo Ink ReachAEMPS Spain AEMPSSpainJun 8La AEMPS informa de un riesgo de suspensión de la administración de insulina en determinadas bombas Minimed 780GAEMPS (Spain)AEMPSSpainJun 8La AEMPS organiza una sesión informativa sobre la Circular 01/2025 de comercio exterior de medicamentosAEMPS (Spain)AEMPSSpainJun 8Sesión informativa sobre la Circular 1/2025 de comercio exterior de medicamentosAEMPS (Spain)AEMPSSpainJun 4La AEMPS impulsa una sesión informativa sobre RECOPS, la nueva aplicación para el registro de comercialización de productos sanitariosAEMPS (Spain)AEMPSSpainJun 4Sesión informativa sobre RECOPS, la nueva aplicación para el registro de comercialización de productos sanitariosAEMPS (Spain)AEMPSSpainJun 4La AEMPS refuerza el control del mercado de productos cosméticos con cerca de 2.000 actuaciones en 2025AEMPS (Spain)AEMPSSpainJun 4OCULOTECT 50 mg/ml COLIRIO EN SOLUCION , 1 frasco de 10 ml (NR: 61982, CN: 755215)AEMPS (Spain)AEMPSSpainJun 3La AEMPS publica el sexto informe de seguimiento del Linfoma Anaplásico de Células Grandes (LACG) asociado a implantes de mama en EspañaAEMPS (Spain)AEMPSSpainJun 2La AEMPS presenta los principales hitos de 2025 en su Memoria de ActividadesAEMPS (Spain)AEMPSSpainJun 2La AEMPS informa del cese de comercialización y retirada del mercado del dispositivo antiatragantamientos DAEMAEMPS (Spain)AEMPSSpainJun 1ORAMORPH 2 MG/ML SOLUCION ORAL , 1 frasco de 100 ml (NR: 62039, CN: 821934)AEMPS (Spain)AEMPSSpainJun 1Solución cardiopléjica, varias presentacionesAEMPS (Spain)AEMPSSpainJun 1La AEMPS informa del cambio en la denominación de Valium solución inyectable para evitar errores de medicaciónAEMPS (Spain)MFDSSouth Korea1d ago[보도참고] 식약처, ‘해썹(HACCP) AI 콘텐츠 공모전’ 개최MFDS Press Releases MFDSSouth Korea1d ago식약처, K-뷰티 인도네시아 수출 장벽 완화 성과MFDS Press Releases MFDSSouth Korea3d ago[보도참고] 3-MCPD 초과 검출된 수입 간장 회수 조치MFDS Press Releases MFDSSouth Korea4d ago[보도참고] 알레르기 유발물질 미표시 '소스 ' 회수 조치MFDS Press Releases MFDSSouth Korea4d ago[정부합동] 하반기 범정부 마약류 합동 특별단속 실시MFDS Press Releases MFDSSouth Korea4d ago[보도참고] 식약처, ‘신약 품목허가·심사 업무절차’ 개정MFDS Press Releases MFDSSouth Korea4d ago[보도참고] 외식·급식 조리식품의 위생·안전관리 기준 강화MFDS Press Releases MFDSSouth Korea4d ago씻고, 차갑게 보관하고, 구별 조리까지...식약처가 제안하는 휴가철 '식중독 예방'MFDS Press Releases MFDSSouth Korea4d ago[보도참고] 식약처, 주방세제 등 리필판매 시범운영을 위한 참여업체 모집MFDS Press Releases MFDSSouth Korea4d ago식약처, 희귀질환 어린이를 위한 식사안전관리 지침 첫 마련 및 현장 소통MFDS Press Releases MFDSSouth Korea5d ago식약처, 식용얼음 안전성 검사 결과 발표MFDS Press Releases MFDSSouth Korea5d ago유네스코 세계유산위원회 식음료 안전관리, 식중독 제로 달성MFDS Press Releases MFDSSouth Korea5d ago[보도참고] 함량시험 부적합 구중청량제 회수 조치MFDS Press Releases MFDSSouth Korea5d ago[보도참고] 식중독균 검출된 '조미건어포' 회수 조치MFDS Press Releases MFDSSouth Korea5d ago[보도참고] 납 기준 초과 검출된 '과·채 주스' 회수 조치MFDS Press Releases MFDSSouth Korea6d ago[보도참고] 식약처 최초 수사 연구모임 ‘셜록홈즈’ 발족MFDS Press Releases MFDSSouth Korea6d ago[보도참고] 식중독균 검출된 '달걀' 회수 조치MFDS Press Releases MFDSSouth KoreaJul 28[부처합동] 바가지요금 근절 위해 엄정대응, 요금 미게시·초과수수 1차 적발에도 영업정지MFDS Press Releases MFDSSouth KoreaJul 28[보도참고] 독성평가용 간 오가노이드 기술, 국내 제약사에 기술이전MFDS Press Releases MFDSSouth KoreaJul 28[보도참고] 식약처, 의료 AI 활성화를 위한 디지털의료기기 인허가 규제 합리화MFDS Press Releases MFDSSouth KoreaJul 28[보도참고] 2026 글로벌 바이오 콘퍼런스(GBC) 사전 등록하세요!MFDS Press Releases MFDSSouth KoreaJul 28‘백세 활력 밥상’ 요리 경연대회 참가자 모집MFDS Press Releases MFDSSouth KoreaJul 28식품 회수·판매 중지 정보, 국민비서 '구삐'로 빠르게 확인하세요MFDS Press Releases MFDSSouth KoreaJul 27[보도참고] 치과 병·의원에 의료용 마약류 안전관리 교육 강화한다MFDS Press Releases MFDSSouth KoreaJul 27[보도참고] 식약처, 화장품 안전성 평가 전문인력 양성 교육 참여자 모집MFDS Press Releases MFDSSouth KoreaJul 27식약처, 팥빙수·우베 디저트 등 배달 음식점 및 인기 음식점 집중…93곳 적발MFDS Press Releases MFDSSouth KoreaJul 24[보도참고] 식약처, 「CDMO 규제지원 특별법」 본격 시행을 위한 하위 규정 입법예고MFDS Press Releases MFDSSouth KoreaJul 24식약처, 하수 내 불법 마약류 31종 확인MFDS Press Releases MFDSSouth KoreaJul 24[보도참고] “화장품이 질염 예방, 여드름 치료”… 의약품 둔갑한 화장품 광고 178건 적발MFDS Press Releases MFDSSouth KoreaJul 23[보도자료] 식약처, ‘올레샷’, ‘먹는 위고비’ 등 다이어트 식품 부당광고 26개소 적발MFDS Press Releases MFDSSouth KoreaJul 23식약처, ‘올레샷’, ‘먹는 위고비’ 등 다이어트 식품 부당광고 26개소 적발MFDS Press Releases MFDSSouth KoreaJul 23[보도참고] 식약처-범부처사업단(2기), K-의료기기 제품화 위해 ‘찾아가는 사전상담’ 착수MFDS Press Releases MFDSSouth KoreaJul 22해외직구 22개 식품서 11종 마약류 검출 국내 반입 차단 조치MFDS Press Releases MFDSSouth KoreaJul 22[보도참고] 식약처, ‘한국형 정밀영양’ 모델 개발 논의MFDS Press Releases MFDSSouth KoreaJul 22[보도참고] 식약처, EU 식품포장재 규제 대응을 위한 분석기술 설명회 개최MFDS Press Releases MFDSSouth KoreaJul 21[보도참고] 잔류농약 기준 초과 검출된 수입 '냉동얼갈이' 회수 조치MFDS Press Releases MFDSSouth KoreaJul 21[보도참고] 건강기능식품 GMP 국제조화 및 소비자 안심 정보제공 강화MFDS Press Releases MFDSSouth KoreaJul 21[부처합동] 식약처, 관세청 공조로 해외직구 위장 불법 수입식품 적발MFDS Press Releases MFDSSouth KoreaJul 20[보도참고] 식약처-제약협회, 글로벌 GMP 이행 기술 지원을 위한 ‘GMP 핫라인’ 본격 가동MFDS Press Releases MFDSSouth KoreaJul 20[보도참고] 식약처, ‘화장품 안전성 평가 제도’ 영상 공모전 개최MFDS Press Releases MFDSSouth KoreaJul 20식약처, 인도네시아 할랄 인증 의무화 대응, 민·관 합동 지원단 현지파견MFDS Press Releases MFDSSouth KoreaJul 16[보도참고] 카드뮴 기준 초과 검출된 수입 '겨우살이(곡기생)' 회수 조치MFDS Press Releases MFDSSouth KoreaJul 16[보도참고] 식중독균 검출된 '과자' 회수 조치MFDS Press Releases MFDSSouth KoreaJul 16식약처, 2026년 하반기 주요 업무 보고MFDS Press Releases MFDSSouth KoreaJul 16[보도참고] 축·수산물 PLS 숏폼 영상 공모전 개최MFDS Press Releases MFDSSouth KoreaJul 16[보도참고] 식약처, 「식품의약품검사법 시행규칙」 개정안 입법예고MFDS Press Releases MFDSSouth KoreaJul 16[보도참고] 마약류 취급주의사항 교육 누구나 온라인에서 편리하게 들으 수 있어요MFDS Press Releases MFDSSouth KoreaJul 16[보도참고] 식약처, 아세안 회원국 대상 식품안전 비상대응 훈련, 평가자로 참여MFDS Press Releases MFDSSouth KoreaJul 16식품영양정보, ‘K-FIND’로 쉽고 빠르게 찾아보세요MFDS Press Releases MFDSSouth KoreaJul 15[부처합동] 마약예방교육, 마약류 위험 인식과 거절 자신감을 높이는 성과로 나타나MFDS Press Releases MFDSSouth KoreaJul 15[보도참고] 식약처, 디지털융합의약품 개발 업계 현장 목소리 청취MFDS Press Releases MFDSSouth KoreaJul 15염소 고기 등 여름 보양식 취급업체 점검, 위반업체 51곳 적발·조치MFDS Press Releases MFDSSouth KoreaJul 15[부처합동] 정부, 코덱스 총회서 K-푸드 국제기준 선도 성과 거둬MFDS Press Releases MFDSSouth KoreaJul 14[보도참고] 식약처, 바이오시밀러 3상 임상 요건 합리화 등 제품화 규제 지원MFDS Press Releases MFDSSouth KoreaJul 14K-푸드 퓨전 조리법 더 맛있고 건강하게MFDS Press Releases MFDSSouth KoreaJul 14식약처, 사회복지시설 및 산후조리원 급식시설 위생점검…19곳 적발MFDS Press Releases MFDSSouth KoreaJul 13KTX 역사 내 음식점, 안심하고 이용하세요MFDS Press Releases MFDSSouth KoreaJul 13[보도참고] 식약처, 유해물질 안전조사로 국민 안심 높인다MFDS Press Releases MFDSSouth KoreaJul 13[보도참고] 식약처, 새로운 다발신경병증 희귀 치료제 허가MFDS Press Releases MFDSSouth KoreaJul 13삼계탕·냉면·치킨 배달 음식점 등 집중 점검MFDS Press Releases PMDAJapan1d ago[SHINSA]Information on biosimilars is updatedPMDA Japan PMDAJapan4d ago[SHINSA]English Translation of Review Report: MiSight 1 DayPMDA Japan PMDAJapanJul 28[IBENTO][IBENTO]ASEAN-Japan Medical Devices Regulatory Symposium 2026 ReportPMDA Japan PMDAJapanJul 24[IBENTO][IBENTO]PMDA-ATC Blood Products Seminar 2026 for PPWG Applications open.PMDA Japan PMDAJapanJul 24[IBENTO][IBENTO]ASEAN-Japan Medical Devices Regulatory Seminar 2026PMDA Japan PMDAJapanJul 24[IBENTO][IBENTO]PMDA-ATC Herbal Medicine Seminar 2026PMDA Japan PMDAJapanJul 24[KOKUSAI]The 8th Asian Network Meeting (ANM) summary has been postedPMDA Japan PMDAJapanJul 24[SHINSA]Considerations for the Clinical Evaluation of Blood Coagulation Factor VIII and Factor IX Products for Pediatric Congenital Hemophilia (Early Consideration) posted.PMDA Japan PMDAJapanJul 21[SHINSA]Available schedule for consultation by the Office of Software as a Medical Device updatedPMDA Japan PMDAJapanJul 17[SHINSA]English Translation of Review Report: RiHEARTPMDA Japan PMDAJapanJul 16[SHINSA]English Translation of Review Report: VorzzzPMDA Japan PMDAJapanJul 14[ANZEN]PMDA Risk Communications: Domperidone (oral preparations) etc. postedPMDA Japan PMDAJapanJul 14[ANZEN]Revisions of PRECAUTIONS: Esomeprazole Magnesium Hydrate, etc. postedPMDA Japan PMDAJapanJul 13[YAKKYOKUKATA]Press Release regarding international activities related to Pharmacopoeia postedPMDA Japan PMDAJapanJul 10[KOKUSAI]PMDA Updates (2026 No.2) postedPMDA Japan PMDAJapanJul 10Reviews and Related ServicesPharmaceuticals and Medical Devices Agency (PMDA)PMDAJapanJul 7[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.429 postedPMDA Japan PMDAJapanJul 7[PMDA]PMDA Concludes a Memorandum of Understanding with the London School of Hygiene & Tropical Medicine (LSHTM) (News Release) (July 6, 2026) [222KB]PMDA Japan PMDAJapanJul 1[PMDA]Conclusion of a Memorandum of Understanding between the Medical University of Vienna and the Pharmaceuticals and Medical Devices Agency (PMDA) (News Release) (June 30, 2026) [263KB]PMDA Japan PMDAJapanJun 30[ANZEN]PMDA Alert for Proper Use of Drugs: Serious hypocarnitinemia and hypoglycaemia in children treated with antibacterials with a pivoxil group (follow-up report) postedPMDA Japan PMDAJapanJun 22[SHINSA]CDx approved for identifying eligible patients (Updated June 16, 2026)PMDA Japan PMDAJapanJun 22[SHINSA]List of Approved Drugs: April 2004 to February 2026PMDA Japan PMDAJapanJun 19[IBENTO][IBENTO]The report for the PMDA Asia office GCP workshop 2026 has been posted.PMDA Japan PMDAJapanJun 19[IBENTO][IBENTO]The report for the PMDA Asia office GMP Workshop Training 2026 has been posted.PMDA Japan PMDAJapanJun 12[YAKKYOKUKATA]PDG March 2026 News postedPMDA Japan PMDAJapanJun 11[SHINSA]List of Approved Medical Devices: April 2004 to September 2025PMDA Japan PMDAJapanJun 10[IBENTO][IBENTO]Workshop on New Approach Methodologies (NAMs) Held following ICCR-20PMDA Japan PMDAJapanJun 8[SONOTA]"Project team for Consideration of Guiding Principles for AI Utilization" has been added in “Projects Across Multi-Offices”PMDA Japan PMDAJapanJun 4[IBENTO][IBENTO]Report on the PMDA-ATC 10th Anniversary Ceremony has been posted.PMDA Japan PMDAJapanJun 1[IBENTO][IBENTO]Symposium for the 10 anniversary of the PMDA Hokuriku BranchPMDA Japan PMDAJapanMay 27[YAKKYOKUKATA]Schedule of JP19-I Publication postedPMDA Japan PMDAJapanMay 25[KOKUSAI]Registration for the ASEAN-Japan Medical Devices Regulatory Symposium is now open.PMDA Japan PMDAJapanMay 22[SHINSA]The new website “Overview of Orphan Drug Designation“ launched.PMDA Japan PMDAJapanMay 22[SHINSA]The new website “Designation / Early Access“ launched.PMDA Japan PMDAJapanMay 19[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updatedPMDA Japan PMDAJapanMay 13[SHINSA]Seven English translations of notifications and administrative notices related to pediatric drug development, including the partial revision of “Planning of the Pediatric Drug Development Program during Development of Drugs for Adults”PMDA Japan PMDAJapanMay 12[IBENTO][IBENTO]PMDA-ATC GMP Inspection Seminar 2026 applications openPMDA Japan MedsafeNew Zealand1d agoPharmac to refresh patient advisory functionPharmac New Zealand MedsafeNew ZealandJun 29More people to access cholesterol-lowering medicinePharmac New Zealand MedsafeNew ZealandJun 24Pharmac introduces a new vision and strategic prioritiesPharmac New Zealand MedsafeNew ZealandJun 24Pharmac funds another ADHD medicine to improve supplyPharmac New Zealand MedsafeNew ZealandJun 24New agreement to save hospitals millionsPharmac New Zealand MedsafeNew ZealandJun 23How personal experience impacts medicines decisionsPharmac New Zealand MedsafeNew ZealandJun 23Funding strengthens rural emergency responsePharmac New Zealand MedsafeNew ZealandJun 23Ensuring continued access to medicines and medical devices for New ZealandersPharmac New Zealand MedsafeNew ZealandJun 16Agenda for August 2026 Pharmacology and Therapeutics Advisory Committee (PTAC) meetingPharmac New Zealand MedsafeNew ZealandJun 9Pharmac to fund medicines used by ambulance providersPharmac New Zealand MedsafeNew ZealandMay 29Agenda for July 2026 Rare Disorders Advisory Committee meetingPharmac New Zealand MedsafeNew ZealandMay 26Pharmac extending consultation period on the proposed changes to diabetes medicine criteriaPharmac New Zealand MedsafeNew ZealandMay 26Agenda for August 2026 Cancer Treatments advisory committee (CTAC) meetingPharmac New Zealand MedsafeNew ZealandMay 26Agenda for June 2026 Cancer Treatments advisory committee (CTAC) meetingPharmac New Zealand MedsafeNew ZealandMay 21More New Zealanders could benefit from funded vaccines from 2027Pharmac New Zealand MedsafeNew ZealandMay 21Agenda for April 2026 Nephrology Advisory Committee meetingPharmac New Zealand MedsafeNew ZealandMay 14Wegovy and Mounjaro for weight loss not fundedPharmac New Zealand MedsafeNew ZealandMay 13Public hospitals to save millions on drug-eluting stentsPharmac New Zealand MedsafeNew ZealandMay 13Consultation on proposed changes to diabetes medicine criteriaPharmac New Zealand MedsafeNew ZealandMay 13Agenda for June 2026 Rheumatology Advisory Committee meetingPharmac New Zealand FDAUnited States1d agoA Sensor for Every Symptom: FDA Puts $1.1 Million Behind Digital Health in Drug TrialsHyman, Phelps & McNamara (FDA Law)FDAUnited 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Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine AmpulesFDA MedWatch FDAUnited States5d agoRegeneron filed Form 10-QSEC EDGAR FDAUnited States5d agoRegeneron filed Form 8-KSEC EDGAR FDAUnited States5d agoBioNTech filed Form 20-F/ASEC EDGAR FDAUnited States5d agoBristol Myers Squibb filed Form 10-QSEC EDGAR FDAUnited States5d agoBristol Myers Squibb filed Form 8-KSEC EDGAR FDAUnited States5d agoGSK filed Form 6-KSEC EDGAR FDAUnited States5d agoSanofi filed Form 6-KSEC EDGAR FDAUnited States5d agoMedicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required PriorFederal Register FDAUnited States5d agoButylated Hydroxytoluene (BHT); Request for Information; Reopening of Comment PeriodFederal Register FDAUnited States5d agoOffice of the Director, National Institutes of Health; Notice of MeetingFederal Register FDAUnited States5d agoOffice of the Secretary; Amended Notice of MeetingFederal Register FDAUnited States5d agoAgency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Health Center Program Forms-OMB No. 0915-0285-RevisionFederal Register FDAUnited States5d agoAnnouncement of the Intent To Award Single-Source Grants (Multiple Recipients) for Necessary Expenses Directly Related to the Consequences of Hurricanes Fiona and IanFederal Register FDAUnited States5d agoAdministrative Costs for Children in Title IV-E Foster CareFederal Register FDAUnited States5d agoBiosimilar User Fee Rates for Fiscal Year 2027Federal Register NAFDAC NigeriaNigeria2d agoNAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the global community in celebrating World Breastfeeding Week 2026NAFDAC Nigeria NAFDAC NigeriaNigeria5d agoHandling Manufacturer Investigation Reports for Medical Devices and IVDsNAFDAC Nigeria NAFDAC NigeriaNigeria6d agoNAFDAC Continued Enforcement of the Ban on Sub-200ml Sachet & PET Bottle Alcoholic Products: Update on Nationwide Mop-Up Operation.NAFDAC Nigeria NAFDAC NigeriaNigeriaJul 20Blacklisting of Onifam Laboratories LtdNAFDAC Nigeria NAFDAC NigeriaNigeriaJul 18Public Alert No. 037/2026 – Alert on Suspected Counterfeit Pulmicort® (Budesonide) Inhalation SuspensionNAFDAC Nigeria NAFDAC NigeriaNigeriaJul 18Public Alert No. 036/2026 – Alert on Suspected Counterfeit Products Mimicking Forxiga® (Dapagliflozin)NAFDAC Nigeria NAFDAC NigeriaNigeriaJul 18Public Alert No. 035/2026 – Alert on the Marketing and Sale of Unregistered Menofix CompositionNAFDAC Nigeria NAFDAC NigeriaNigeriaJul 13Public Alert No. 034/2026 – Niger Republic Imposes Import Ban on Bulmex Parboiled Rice from India due to Metallic ContaminationNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 24End-Of-Pilot Validation, Learning And Dissemination Event of The 2026 Annual Market-Level Large Scale Food Fortification (LSFF) Maiden Digital Monitoring And Compliance SurveyNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 19Public Alert No. 033/2026 – Alert on the Voluntary Recall of Sporidex Suspension 125 mg/5 ml (Batch No. DFG4606A)NAFDAC Nigeria NAFDAC NigeriaNigeriaJun 19Public Alert No.032/2026 – Alert on the Confiscation of a Banned Alcoholic Energy Drink in GhanaNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 19Public Alert No. 31/2026- Recall of Sexual Enhancement Product Due to Undeclared Pharmaceutical IngredientsNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 182026 World Food Safety Day Capacity Building Event For NAFDAC OfficersNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 8Public Alert No. 030/2026: Alert on the Withdrawal of Levamisole-Containing Medicines as endorsed by the Italian Medicines Agency (AIFA) over serious Neurological risksNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 8Public Alert No. 029/2026 – Recall of Impala Brand Gel Nail Polish Products by Brazilian Health Regulatory Authority(ANVISA)NAFDAC Nigeria NAFDAC NigeriaNigeriaJun 8Public Alert No. 028/2026- Recall Of Children’s Ibuprofen Oral Suspension in the United States Due To Potential Contamination With Foreign MaterialNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 8NAFDAC Joins Federal Ministry of Health & Social Welfare, National Food Safety Management Committee and the rest of the world in celebrating World Food Safety DayNAFDAC Nigeria NAFDAC NigeriaNigeriaJun 2NAFDAC Launches Improved Med Safety App to Strengthen Reporting of Substandard and Falsified Medical Products and Adverse Drug Reactions in NigeriaNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 21Public Alert No. 027/2026 -Alert on European Union Ban on the Sale and Orders the Destruction of Defective Signo FFP2 Particle Filter Mask Produced in ChinaNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 20Public Alert No. 26/2026 – WHO Alert on Substandard ACCUPAQUE (Iohexol), OMNIPAQUE (Iohexol) and VISIPAQUE (Iodixanol) in all WHO regionsNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 20Public Alert No. 025/2026 -Alert on the Recall Specific Batches of Antacid (Citro-Soda regular) in South AfricaNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 19Press Release On NAFDAC Findings On Extended Shelf-Life Of Bread (BON)NAFDAC Nigeria NAFDAC NigeriaNigeriaMay 18The Pharmaceutical Industry and the Impact of the 5 + 5 PolicyNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 14NAFDAC becomes the 24th member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human UseNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 13Pharmaceutical Traceability & Supply Chain MonitoringNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 12NAFDAC’s WHO ML3 Re-Benchmarking Success: Sustaining Regulatory ExcellenceNAFDAC Nigeria NAFDAC NigeriaNigeriaMay 12NAFDAC Introduces Improved Med Safety App for Reporting Substandard and Falsified Medical ProductsNAFDAC Nigeria WHO/ICHGlobal2d agoEbola disease caused by Bundibugyo virus - Democratic Republic of the CongoWHO Disease Outbreak News WHO/ICHGlobalJul 28Better Together: Can Sites, Sponsors, and CROs Have a Kumbaya Moment?ACRP Association WHO/ICHGlobalJul 24WHO good manufacturing practices for pharmaceutical products: Main principlesZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on Goods Manufacturing Practices(WHO)Zambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on Goods Manufacturing PracticesZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24SI-No-57-of-2017-Importation-and-ExportationZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines-on-Application for Clinical Trial AuthorisationZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24APPLICATION-FOR-GRANT-OF-MARKETING-AUTHORISATION-OF-COSMETICS-FOR-USE-IN-ZAMBIAZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24REQUIREMENTS-FOR-THE-LISTING-OF-COSMETICSZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24ZAMRA-Cosmetic-Guidelines-22Mar2023-v.LC-final-1Zambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24API FPP Assessment Template-LOQ_v0 – ZAZIBONAZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Roles of key players in Zazibona-process_v0 – ZAZIBONAZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Expression of Interest – ZAZIBONAZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Application acceptance letter – ZAZIBONAZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Applicants Cover letter template_v0 – ZAZIBONAZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on Bioavailability or BioequivalenceZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on submission of applications in CTD FormatZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Checklist for Submission of DossiersZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24GUIDELINES ON APPLICATION FOR GRANT OF MARKETING AUTHORISATION OF NON IVDSZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines of Traceability of MedicinesZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on Recall of Medicines and Allied SubstanceZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Template for comments on Guidelines on Identification and Labelling of Medicines and Allied Substances and Master Data SharingZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on Renewal of Marketing Authorization of Medicines and Allied Substances ZAMRA_2019v3Zambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Essential Principles of Safety and Performance of Medical Devices-v1Zambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines for Label and Instructions For Use for Medical DevicesZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on the Establishment of a Health ShopZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on the Principles of Medical Devices Classifications v1Zambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Temporary Guidelines for Hand SanitizersZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Application for Marketing Authorisation CondomsZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on Good Distribution PracticesZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines for the Establishment of an Agro Veterinary ShopZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on the Establishment of a Health ShopZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on the Establishment of a Pharmaceutical Retail OutletZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Guidelines on the Establishment of a Pharmaceutical Wholesale BusinessZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 24Safety evaluation of certain contaminants in food: prepared by the one hundred and first meeting of the...WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 24Agro-vert-shops-regulationsZambia Medicines Regulatory Authority (ZAMRA)WHO/ICHGlobalJul 23Seven strategies to prevent drowning: technical package for policy-makersWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 23ACRP Fellow Adapts to Change While “Staying Grounded in the Principles That Matter Most”ACRP Association WHO/ICHGlobalJul 22Consolidated HIV guidelines: service deliveryWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 21Establishing a national programme for guideline adaptation: key steps and functionsWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 21WHO Global Traditional Medicine Centre: Annual Report 2025WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 20Formative evaluation of the Global Health Cluster: Web annexesWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 20WHO Drug Information - Volume 40, No. 2WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 18Ebola disease caused by Bundibugyo virus, Democratic Republic of the Congo & UgandaWHO Disease Outbreak News WHO/ICHGlobalJul 17Eleventh Meeting of the WHO South-East Asia Regional Verification Commission for Measles and Rubella...WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 15Global biopharmaceutical CEOs response to reforms introduced in GermanyIFPMA Global WHO/ICHGlobalJul 15ACRP Certification Exams Transition to ICH E6(R3) on July 15ACRP Association WHO/ICHGlobalJul 15Risk reduction of cognitive decline and dementia: WHO guidelines, second editionWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 14WHO target product profile for Bundibugyo virus disease vaccines, 14 July 2026WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 14Guideline on doxycycline post-exposure prophylaxis for sexually transmitted infections among men who...WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 14A Visit with the Africa Clinical Research NetworkACRP Association WHO/ICHGlobalJul 13The Diagnostic testing for Ebola disease and Marburg virus disease: interim guidance, 9 July 2026WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 9Integrated approach to management of skin-related neglected tropical diseases and common skin conditionsWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 9WHO Expert Committee on Biological Standardization: eighty-first reportWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 8Ending the neglect to attain the sustainable development goals: noma control: technical briefWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 8Global status report on cancer 2026: the future we choose togetherWHO (Pharma/Health Innovation)WHO/ICHGlobalJul 8WHO optimal antiretroviral dosing guidance: recommendations for dosing medicines for HIV prevention and...WHO (Pharma/Health Innovation)WHO/ICHGlobalJul 7To be Labeled a Success, eConsent Must Deliver on Promises for Participants, Sites, and SponsorsACRP Association WHO/ICHGlobalJul 6Statement on PABS Instrument at the seventh meeting of the Intergovernmental Working Group (IGWG 7) on the WHO Pandemic AgreementIFPMA Global WHO/ICHGlobalJul 3Ebola disease caused by Bundibugyo virus, Democratic Republic of the Congo & UgandaWHO Disease Outbreak News Health CanadaCanada3d agoNotice of Compliance (NOC) Data ExtractsHealth Canada Drug Products Health CanadaCanada4d agoPharmasave Regular Strength Dairy Digestive Supplement Lactase Enzyme: Affected lot is labelled with the incorrect Natural Product Number (NPN) on the carton.Health Canada Recalls & Alerts Health CanadaCanada4d agoFemyso: Affected lot may contain two green Mifepristone cartons or two pink Misoprostol cartons instead of one of each.Health Canada Recalls & Alerts Health CanadaCanada5d agoCanada’s search portal for clinical trialsHealth Canada Drug Products Health CanadaCanada5d agoNew guidance and public search portal for clinical trials approved in Canada: NoticeHealth Canada Drug Products Health CanadaCanada5d agoAzurion SystemsHealth Canada Recalls & Alerts Health CanadaCanada6d agoRegister of Innovative DrugsHealth Canada Drug Products Health CanadaCanada6d agoOxygen 100%: Gas cylinders containing commercial grade oxygenHealth Canada Recalls and Safety Alerts Health CanadaCanada6d agoIQecg® Digital ECGHealth Canada Recalls and Safety Alerts Health CanadaCanada6d agoBlanketrol® II 115V and Blanketrol® III 115VHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 27Sphere-9™ CatheterHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 27Spacelabs Healthcare Xhibit® Central StationHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 27Harmonic Arts Holy Basil Tincture; Out of Specification (total aerobic microbial count)Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 25Pharmaceutical and Life Sciences Sector Task Force: Report to the ministers of health and industryHealth Canada Drug Products Health CanadaCanadaJul 23OverStitch™ Suture Cinch and Suture Cinch–LongHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 23HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500P - Membrane TailHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 22HeartSine® Samaritan® PAD SAM 350P/SAM 360P/SAM 500PHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 22DCA Vantage® HbA1c (DX Claim)Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 21Shimadzu X-ray High Voltage GeneratorsHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 21Mequ A/S ºM Warmer LeakageHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 21Cardinal Health - Presource® Kits Containing the Ritmed® Neurological SpongesHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 20Philips Achieva and Ingenia SystemsHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 17Monthly update to the submissions under review listsHealth Canada Drug Products Health CanadaCanadaJul 17Monthly update to the generic submissions under review listHealth Canada Drug Products Health CanadaCanadaJul 17Merge PACSHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 17ER-Spec Single-Use Vaginal Speculum with LED Light SourceHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 17Atellica® CH Urine Albumin (UAlb)Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 174K UHD LCD MonitorHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 16V-Loc™ 90 and 180 Suture ProductsHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 16StrykeFlow PS and AHTOHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 16Solar™ GIHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 16SEMA 3Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 16The Ministerial Reliance OrderHealth Canada Drug Products Health CanadaCanadaJul 16Consultation on draft guidance on Ministerial Reliance Order for certain human and veterinary drugsHealth Canada Drug Products Health CanadaCanadaJul 16Improving access to drugsHealth Canada Drug Products Health CanadaCanadaJul 16Consultation on a proposed pilot approach to prioritize certain generic drug submissions involving domestic manufacturing within the review queueHealth Canada Drug Products Health CanadaCanadaJul 15Presource ®Kits containing Teleflex Pilling® Wecksorb NeurospongeHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 15Leoni PlusHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 13Oribe Serene Scalp Densifying Shampoo; Presence of bacterial contaminationHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 13BD ChloraPrep™ Clear - 1mL Applicator: Product sterilityHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 13Apo-Tiotropium Capsules; Out-of-specification (particle size)Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 10Product Monograph Brand Safety UpdatesHealth Canada Drug Products Health CanadaCanadaJul 9Phantom® Hindfoot TTC/TC Ball Tipped Guide RodHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 9ºM WarmerHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 9Astral 150™Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 8Two lots of Omnitrope injectable human growth hormone recalled due to cracked cartridgesHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 8Allura Xper FD10Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 8Alice Le System - Sleepware SoftwareHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 7TAVNEOS (avacopan) and Health Canada’s Review of Data Integrity ConcernsHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 6JAMP Chlorthalidone 12.5 mg tablet: Out of specification (Dissolution)Health Canada Recalls and Safety Alerts Health CanadaCanadaJul 6Hotline IV Fluid Warmer System & AccessoriesHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 3Urinary Catheter Trays containing Cliniclean Pericare WipesHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 3Omni-Tract Surgical Retractor SystemHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 3Intramedullary Bone Saw Blade AssemblyHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 3Hybrid Hydrophilic MicroguidewireHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 3DLP Select 3D Arterial Cannula and DLP Elongated One Piece Arterial CannulaeHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 3Drug Product Database data extract [2026-07-02]Health Canada Drug Products Health CanadaCanadaJul 2NephroMax High Pressure Nephrostomy Balloon CatheterHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 2LIFECODES LSA Class IIHealth Canada Recalls and Safety Alerts Health CanadaCanadaJul 2Glidesheath Slender® Introducer SheathHealth Canada Recalls and Safety Alerts Consejo Superior de Salud Pública (El Salvador)El Salvador3d agoLanzamiento de la app DoctorSV para atención médica virtualConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El Salvador3d agoActo de juramentación de nuevos miembros del Consejo Directivo y Junta de VigilanciasConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorJul 16CONSULTA PÚBLICA REQUERIMIENTOS TÉCNICOS ADMINISTRATIVOSConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorJul 3Procesos de Compras UCPConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorJun 23Curso de Legislación Laboral aplicada a la Regencia de Servicios de SaludConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorMay 23fachada consejoConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorMay 14Principales Logros Consejo Directivo y JVPS período 2024-2026Consejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorMay 7Curso básico para Regentes de Laboratorio ClínicoConsejo Superior de Salud Pública (El Salvador)Consejo Superior de Salud Pública (El Salvador)El SalvadorMay 6Diplomado en Farmacología de los Tratamientos de las Enfermedades Infecciosas, Quimioterapéuticos y Vacunas», entre Asociación MÁS QUE FARMACIA y la Junta de Vigilancia de la Profesión Químico Farmacéutica (JVPQF)Consejo Superior de Salud Pública (El Salvador)FAMHPBelgium3d agoPRAC juli 2026: nieuwe veiligheidsaanbevelingen voor anticonceptiemiddelen met desogestrel en etonogestrel en voor LitfuloFAMHP Belgium FAMHPBelgium4d agoBenzodiazepines en aanverwante geneesmiddelen: herhaling van de aanbevelingen voor een rationeel gebruikFAMHP Belgium FAMHPBelgiumJul 17Update of document on approval dates for variations, renewals and notifications for medicinal products for human useFAMHP (Belgium)FAMHPBelgiumJul 17Update van het document over goedkeuringsdatum van variaties, hernieuwingen en notificaties bij geneesmiddelen voor menselijk gebruikFAMHP Belgium FAMHPBelgiumJul 17La version mise à jour du formulaire de demande d'autorisation de mise sur le marché est désormais disponible pour les procédures nationales, de reconnaissance mutuelle et décentraliséesFAMHP Belgium FAMHPBelgiumJul 16DatrowayFAMHP Belgium FAMHPBelgiumJul 15IMDYLLTRAFAMHP Belgium FAMHPBelgiumJul 13SigniforFAMHP Belgium FAMHPBelgiumJul 8Beperkte beschikbaarheid van Azactam 1 g en 2 g poeder voor oplossing voor injectie/infusie: aanbevelingen voor artsen-specialisten en ziekenhuisapothekersFAMHP Belgium FAMHPBelgiumJul 7Toekomstige Europese wetgevingen: stand van zakenFAMHP Belgium FAMHPBelgiumJul 1VAMREG disponible à partir du 1 juillet 2026 : début de l’enregistrement obligatoire des antibiotiques à usage vétérinaireFAMHP Belgium FAMHPBelgiumJul 1La nouvelle application web BioVigilance est disponible !FAMHP Belgium FAMHPBelgiumJul 1PRAC juni 2026: herziening afgerond van veiligheidssignaal over valproaat en verwante stoffen en aanbeveling voor gezondheidszorgbeoefenaars met nieuwe veiligheidsgegevens over chikungunya-vaccin IxchiqFAMHP Belgium FAMHPBelgiumJun 26Mexiletine PRFAMHP Belgium FAMHPBelgiumJun 26Disponibilité améliorée du Zypadhera (poudre et solvant pour suspension injectable à libération prolongée) : assouplissement et recommandations adaptées pour les médecins (spécialistes), les pharmaciens (hospitaliers) et les patientsFAMHP Belgium FAMHPBelgiumJun 25ZepzelcaFAMHP Belgium FAMHPBelgiumJun 25AtrasentanFAMHP Belgium FAMHPBelgiumJun 18TibsovoFAMHP Belgium FAMHPBelgiumJun 15BijdragenFAMHP Belgium FAMHPBelgiumJun 8Geef uw mening over een genetisch gewijzigd geneesmiddel tegen retinoschisisFAMHP Belgium FAMHPBelgiumJun 3Contactpunt afdeling Geneesmiddelen voor Diergeneeskundig GebruikFAMHP Belgium FAMHPBelgiumMay 28Flash VIG-news - Faites attention au soleil lorsque vous prenez certains médicamentsFAMHP Belgium FAMHPBelgiumMay 28EUDAMED : précisions concernant les obligations à partir du 28 mai 2026FAMHP Belgium FAMHPBelgiumMay 26Jyseleca®FAMHP Belgium FAMHPBelgiumMay 22Inscrivez-vous à la nouvelle formation sur la nomenclature européenne des dispositifs médicauxFAMHP Belgium FAMHPBelgiumMay 19Consultation publique sur la mise à jour des lignes directrices relatives au paracétamolFAMHP Belgium FAMHPBelgiumMay 11Flash VIG-news - Paracétamol : bonnes pratiques d’utilisation contre la douleur et la fièvre chez les enfantsFAMHP Belgium EMAEU4d agoNew leadership team appointmentsEuropean Medicines Agency EMAEUJul 24Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026European Medicines Agency EMAEUJul 23Cancer DeathsEFPIA Europe EMAEUJul 23Cancer CasesEFPIA Europe EMAEUJul 23Cancer Comparator Report 2025expand_moreexpand_lesschevron_rightEFPIA Europe EMAEUJul 17Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 July 2026European Medicines Agency EMAEUJul 15EMA and EISMEA boost cooperation to accelerate health innovationsEuropean Medicines Agency EMAEUJul 15Executive Director Emer Cooke's speech at the European Parliament's Committee on Public HealthEuropean Medicines Agency EMAEUJul 10Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2026European Medicines Agency EMAEUJul 7EMA fast tracks review of a medicine for metastatic pancreatic cancerEuropean Medicines Agency EMAEUJun 15MEPs and partner organisations call for investments in vaccine R&D to support EU and global health security and preparednessVaccines Europe ANMAT NoticiasArgentina4d agoIncorporación al MERCOSUR de la nueva definición de contaminante en alimentosANMAT Noticias ANMAT NoticiasArgentina4d agoActualización del Código Alimentario Argentino sobre materiales celulósicos en contacto con alimentosANMAT Noticias ANMAT NoticiasArgentina5d agoActualización del Código Alimentario Argentino sobre disposiciones para envases, revestimientos, utensilios, tapas y equipamientos metálicos en contacto con alimentosANMAT Noticias ANMAT NoticiasArgentina6d agoANMAT establece la condición de venta libre para diez ingredientes farmacéuticos activosANMAT Noticias ANMAT NoticiasArgentinaJul 27ANMAT dispuso la baja de habilitación de la firma CASA OTTO HESS S.A.ANMAT Noticias ANMAT NoticiasArgentinaJul 22Titulares de Establecimientos y Directores Técnicos deberán acreditar la inexistencia de antecedentes penales para su habilitación y designaciónANMAT Noticias ANMAT NoticiasArgentinaJul 21ANMAT dispone la baja de certificados de establecimientos y cancela registros de productos médicos de distintas firmasANMAT Noticias ANMAT NoticiasArgentinaJul 20ANMAT canceló la habilitación para tránsito interjurisdiccional de la firma JMG S.A.ANMAT Noticias ANMAT NoticiasArgentinaJul 15ANMAT simplifica el marco regulatorio para las modificaciones posteriores al registro de especialidades medicinales de origen biológicoANMAT Noticias ANMAT NoticiasArgentinaJul 7Incorporación al MERCOSUR del nuevo Reglamento Técnico para la leche UAT (Ultra Alta Temperatura - UHT)ANMAT Noticias ANMAT NoticiasArgentinaJul 7ANMAT levantó la inhibición de actividades productivas y la inmovilización preventiva de lotes de la firma DRAWER S.A.ANMAT Noticias ANMAT NoticiasArgentinaJul 2Nueva convocatoria de la Revista Científica ANMATANMAT Noticias ANMAT NoticiasArgentinaJun 29ANMAT actualiza el listado de sustancias sujetas a fiscalización especialANMAT Noticias ANMAT NoticiasArgentinaJun 27ANMAT recibió a las Autoridades Regulatorias Nacionales de Referencia de las AméricasANMAT Noticias ANMAT NoticiasArgentinaJun 26Incorporación al Mercosur sobre productos de limpieza y afinesANMAT Noticias ANMAT NoticiasArgentinaJun 26ANMAT inhibió las actividades productivas de la firma DIATER S.R.L.ANMAT Noticias ANMAT NoticiasArgentinaJun 20ANMAT fortalece su capacidad de referencia regional en el control de vacunas antigripalesANMAT Noticias ANMAT NoticiasArgentinaJun 16ANMAT prohíbe el tránsito interjurisdiccional de productos médicos de IGMA INSUMOS HOSPITALARIOS S.R.L.ANMAT Noticias ANMAT NoticiasArgentinaJun 11ANMAT consolidó su participación en los principales espacios internacionales de regulación farmacéuticaANMAT Noticias ANMAT NoticiasArgentinaJun 8Incorporación al Mercosur sobre “materiales, envases y equipamientos celulósicos destinados a estar en contacto con alimentos"ANMAT Noticias ANMAT NoticiasArgentinaJun 8Incorporación de la actualización MERCOSUR sobre el uso de almidones en quesos de muy alta humedadANMAT Noticias ANMAT NoticiasArgentinaJun 8Incorporación de la actualización MERCOSUR sobre límites de arsénico en arroz y sus derivadosANMAT Noticias ANMAT NoticiasArgentinaJun 6Nuevo proyecto para la opinión públicaANMAT Noticias ANMAT NoticiasArgentinaJun 5ANMAT deja sin efecto la baja de habilitación de la Droguería Alto ValleANMAT Noticias ANMAT NoticiasArgentinaJun 1Actualización de aranceles para trámites en ANMATANMAT Noticias ANMAT NoticiasArgentinaMay 23Argentina fortalece su posicionamiento en investigación clínica farmacológicaANMAT Noticias ANMAT NoticiasArgentinaMay 22Nuevo proyecto para la opinión públicaANMAT Noticias ANMAT NoticiasArgentinaMay 22ANMAT establece una nueva Sustancia de Referencia Farmacopea ArgentinaANMAT Noticias ANMAT NoticiasArgentinaMay 22ANMAT y la Facultad de Farmacia y Bioquímica de la UBA llevarán a cabo un Programa de Becas para estudiantes avanzadosANMAT Noticias ANMAT NoticiasArgentinaMay 21ANMAT incorporó al ordenamiento nacional requisitos mínimos para inspecciones de productos controladosANMAT Noticias ANMAT NoticiasArgentinaMay 21ANMAT inhibió las actividades productivas de la firma PM CHEMISTRY S.R.L.ANMAT Noticias ANMAT NoticiasArgentinaMay 21ANMAT incorpora nuevas modificaciones al listado de sustancias en cosméticos y productos de higiene personalANMAT Noticias ANMAT NoticiasArgentinaMay 21ANMAT incorpora nueva normativa MERCOSUR sobre sustancias en cosméticos y productos de higiene personalANMAT Noticias ANMAT NoticiasArgentinaMay 21Revista Científica ANMAT ingresa al Catálogo 2.0 de LatindexANMAT Noticias ANMAT NoticiasArgentinaMay 19ANMAT actualiza aranceles y reduce costos para el 75% de los importadores de medicamentos y productos médicosANMAT Noticias ANMAT NoticiasArgentinaMay 19Nuevos proyectos de consulta para la opinión públicaANMAT Noticias ANMAT NoticiasArgentinaMay 15Nuevas incorporaciones al Código Alimentario ArgentinoANMAT Noticias ANMAT NoticiasArgentinaMay 15Actualización del sistema de identificación digital en envases de especialidades medicinalesANMAT Noticias ANMAT NoticiasArgentinaMay 15ANMAT incorpora modificaciones del MERCOSUR sobre sustancias en cosméticosANMAT Noticias ANMAT NoticiasArgentinaMay 14ANMAT incorpora nueva Resolución del Grupo Mercado Común para adecuar normativa a los nuevos estándares del MercosurANMAT Noticias ANMAT NoticiasArgentinaMay 14ANMAT no intervendrá en los trámites de solicitud de Autorización de Importación/ Exportación de productos con SOMATROPINAANMAT Noticias ANMAT NoticiasArgentinaMay 14ANMAT impulsa la cooperación regulatoria regional y la actualización normativa dentro del MercosurANMAT Noticias ANMAT NoticiasArgentinaMay 9Corrección del mercado de lotes de ATACAND y ATACAND DANMAT Noticias ANMAT NoticiasArgentinaMay 8ANMAT adecua la normativa nacional sobre cosméticos y productos de higiene a los nuevos estándares del MERCOSURANMAT Noticias FIFARMA NewsLatAm5d agoFIFARMA se une à Aliança para a Eliminação do HIV nas AméricasFIFARMA News FIFARMA NewsLatAm5d agoFIFARMA Joins the Alliance for the Elimination of HIV in the AmericasFIFARMA News FIFARMA NewsLatAm5d agoFIFARMA se suma a la Alianza para la Eliminación del VIH en las AméricasFIFARMA News FIFARMA NewsLatAmJun 13América Latina llega a la mesa global de la salud: Yaneth Giha es elegida Vicepresidenta del Consejo de IFPMAFIFARMA News ANVISABrazil5d agoInterfarma integra o CNCP e amplia contribuição ao combate à pirataria e defesa da inovaçãoInterfarma Brazil ANVISABrazil6d agoInterfarma integra Coalizão Empresarial contra a DesinformaçãoInterfarma Brazil ANVISABrazilJul 27Marco Legal impulsiona pesquisa clínica e traz benefícios econômicos e acesso mais rápido à inovaçãoInterfarma Brazil ANVISABrazilJul 24Medicamentos oncológicos considerados essenciais pela OMS ainda não chegam aos pacientes do SUS, aponta levantamento da InterfarmaInterfarma Brazil ANVISABrazilJul 23Artigo: O verdadeiro valor da inovação está na jornada do pacienteInterfarma Brazil ANVISABrazilJul 23Interfarma na imprensa: estudo da Interfarma sobre judicialização da saúde é destaque na mídiaInterfarma Brazil ANVISABrazilJul 8Interfarma na imprensa: Jornal da Record destaca potencial do Brasil para liderar pesquisa clínicaInterfarma Brazil ANVISABrazilJul 7Em nota, entidades do setor farmacêutico alertam para riscos de produtos sem registro no BrasilInterfarma Brazil ANVISABrazilJun 29Interfarma na imprensa: Estudo da Interfarma sobre judicialização é destaque na Folha de S.PauloInterfarma Brazil ANVISABrazilJun 25Interfarma apresenta estudo sobre avanços da pesquisa clinica no Brasil: país ganha posições importantesInterfarma Brazil ANVISABrazilJun 3Setor farmacêutico está entre os principais depositantes de patentes no Brasil, segundo ranking do INPIInterfarma Brazil ANVISABrazilMay 23Em ano de 35 anos, Interfarma consolida protagonismo e resultados que moldam a agenda da saúdeInterfarma Brazil ANVISABrazilMay 22Pesquisa clínica: Brasil sobe no ranking global, mas tem dificuldade para recrutar pacientes para estudosInterfarma Brazil ANVISABrazilMay 22Interfarma na imprensa: Interfarma destaca papel da inovação no enfrentamento do câncer no SUS em artigo no JOTAInterfarma Brazil ANVISABrazilMay 21Entidades do setor farmacêutico apoiam Anvisa e PF no combate a medicamentos irregularesInterfarma Brazil ANVISABrazilMay 21Patentes farmacêuticas demoram 20% mais que a média geral para decisão no BrasilInterfarma Brazil ANVISABrazilMay 14Acesso a medicamentos no SUS exige previsibilidade, escala e regulação eficiente, destaca InterfarmaInterfarma Brazil ANVISABrazilMay 7Fifarma Annual Summit 2026 define roteiro para acelerar o acesso à inovação em saúde na América LatinaInterfarma Brazil ANVISABrazilMay 6Interfarma defende proibição de manipulação de medicamentos à base de GLP‑1Interfarma Brazil INFARMA PolandPoland5d agoZmiany tak, ale w dialogu i likwidujące barieryINFARMA Poland INFARMA PolandPolandJun 26Stanowisko do projektu ustawy o zmianie ustawy o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych oraz niektórych innych ustawINFARMA Poland INFARMA PolandPolandJun 26Każde 1 euro zainwestowane w nowe leki przynosi Europie 5,67 euro zwrotu.INFARMA Poland INFARMA PolandPolandJun 18Julie Enevold Brooker oraz Gábor Sztaniszláv zostali wybrani do Zarządu Związku Pracodawców Innowacyjnych Firm Farmaceutycznych INFARMAINFARMA Poland INFARMA PolandPolandJun 11Przedłużenie dodatkowego świadectwa ochronnego mogłoby dziesięciokrotnie zwiększyć inwestycje w badania i rozwój w EuropieINFARMA Poland INFARMA PolandPolandMay 25Access GAP 2026: Polska pozostaje liderem państw V4 w dostępie do innowacyjnych terapiiINFARMA Poland INFARMA PolandPolandMay 19W.A.I.T. Indicator: Polska awansuje o 3 miejsca i po raz pierwszy w historii jest powyżej średniej w Europie pod względem dostępu do innowacyjnych terapiiINFARMA Poland INFARMA PolandPolandMay 19Pacjenci w Europie czekają dłużej na nowe leki, a nierówności między państwami członkowskimi rosną.INFARMA Poland Thai FDAThailandJul 2525 ก.ค. 69อย. กำชับผู้ประกอบการใช้วัตถุเจือปนอาหารที่มีไนไตรท์ให้ถูกต้อง ตรวจเข้มสถานที่ผลิตอาหารกลุ่มเสี่ยง พร้อมเผยแพร่สื่อแนะนำการใช้อ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 2424 ก.ค. 69อย. แท็กทีม 11 องค์กร คิกออฟ ยกระดับอาหารอนาคตไทย ผ่านระบบบัญชี Positive list หนุน SMEs แข่งขันระดับสากลอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 2424 ก.ค. 69อย. เดินหน้าขับเคลื่อน “ทางเลือกสุขภาพ” ติวเข้มผู้ประกอบการทั่วประเทศ มุ่งเพิ่มผลิตภัณฑ์สุขภาพ สร้างทางเลือกที่ดี ลดเสี่ยง NCDs อย่างยั่งยืนอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1717 ก.ค. 69อย. เติมความรู้ ชูอาหารปลอดภัย ลงพื้นที่ ตลาดสด อตก. แนะวิธีเช็ก สารฟอกขาว - สารกันรา ยกระดับตลาดสดปลอดภัยใจกลางเมืองกรุงอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1515 ก.ค. 69ข่าวประกาศผลการตรวจพิสูจน์อาหาร อย. แจ้งเตือนประชาชน หยุดบริโภคผลิตภัณฑ์อาหาร 25 รายการ หลังตรวจพบเป็นอาหารปลอมอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1515 ก.ค. 69อย. เตือน ผลิตภัณฑ์เสริมอาหาร “วิสโตริน” อ้างรักษาโรคทางตาอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1414 ก.ค. 69อย. ยืนยันผลตรวจพิสูจน์สายพันธุ์ปลา จากผู้เชี่ยวชาญด้านสายพันธุ์ปลา กรมประมงอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1414 ก.ค. 69อย. รับการตรวจประเมิน PIC/S ตอกย้ำมาตรฐาน GMP ไทย สร้างความเชื่อมั่นคุณภาพยาอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1414 ก.ค. 69“รัฐมนตรีฯ พัฒนา” นำทีมเผาทำลาย “ยาเสพติดของกลาง” รวม 17 ตัน ตอกย้ำความเชื่อมั่นไม่ย้อนกลับมาทำลายสังคมได้อีกอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 1414 ก.ค. 69อย. ตรวจสอบแล้ว ยาหยอดตาที่สหรัฐฯ เรียกคืน ไม่มีจำหน่ายในไทยอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 807 ก.ค. 69อย. - ศุลกากร ร่วมปั้นนักธุรกิจสุขภาพ ขับเคลื่อนเศรษฐกิจไทย ก้าวล้ำสู่มาตรฐานสากลอ่านเพิ่มเติม →Thai FDA Thai FDAThailandJul 707 ก.ค. 69อย. เดินหน้ากวาดล้างผลิตภัณฑ์สุขภาพผิดกฎหมาย ผนึก บช.น. ทลายโรงงานผลิตและโกดังเก็บอาหารเสริมลดน้ำหนัก "บาชิ"อ่านเพิ่มเติม →Thai FDA ANSMFranceJul 24République démocratique du Congo : 8 tonnes de médicaments acheminées en Ituri pour soutenir la réponse à l'épidémie d'EbolaLEEM France ANSMFranceJul 22Qu’attendent les Français de leur système de santé ? La concertation nationale pour l’avenir du médicament livre ses premières conclusionsLEEM France ANSMFranceJul 16Hidden costs in Environmental Monitoring: Why Quality is more expensive than you think?A3P France ANSMFranceJul 16Overcoming the Financing Barrier to the Environmental Transition in Pharmaceutical ManufacturingA3P France ANSMFranceJul 16Dépasser la barrière du financement de la transition environnementale de la production pharmaA3P France ANSMFranceJul 16Ways to Optimize Manual Visual Inspections Beyond Regulatory RequirementsA3P France ANSMFranceJul 16Factoring Sustainability Procurement decisions: Environmental AspectsA3P France ANSMFranceJul 16Use of a Justified Sample Size and Criteria for the Validation of Visual Inspection ProcessesA3P France ANSMFranceJul 16Major Discrepancies in Visual Inspections: Lessons from the ANSM Inspections, 2023–2025A3P France ANSMFranceJul 16Biopharma Industry Readiness for AI Implementation. Key Questions & Answers.A3P France ANSMFranceJul 16Artificial Intelligence in GMP Environments: Where Do We Stand?A3P France ANSMFranceJul 16Digitalisation: Considerations for Data Integrity & Data ReviewA3P France ANSMFranceJul 15Le Leem finalise sa gouvernance et se mobilise pour les grandes échéances politiques de santé à venirLEEM France ANSMFranceJul 916 tonnes de produits de santé acheminées vers Kharkiv et plusieurs autres villes ukrainiennes.LEEM France ANSMFranceJun 30L’industrie pharmaceutique poursuit son engagement en faveur de l’insertion et de l’emploi des personnes en situation de handicapLEEM France ANSMFranceJun 29Tulipe en 2025 : +16 % de produits de santé expédiés pour renforcer l’accès aux soinsLEEM France ANSMFranceJun 29Plus de 109 tonnes de produits de santé mobilisées depuis le début de l’année 2026LEEM France ANSMFranceJun 25Baromètre 360° de l’attractivité de la France pour l’industrie pharmaceutique - Edition 2026 : Accès aux traitements, progrès thérapeutique, attractivité de la France : reprendre l’avantage ou décrocher ?LEEM France ANSMFranceJun 16INVITATION CONFERENCE DE PRESSE : Résultats 2026 du baromètre 360° de l’attractivité de la France pour l’industrie pharmaceutiqueLEEM France ANSMFranceJun 11L'industrie pharmaceutique appelle le G7 à investir dans l'innovation pour stimuler la compétitivité, la résilience et la croissanceLEEM France ANSMFranceJun 10Jean-François Brochard élu Président du Leem et composition du nouveau BureauLEEM France ANSMFranceJun 8Crise au Moyen-Orient, un impact sur les prix de production des médicamentsLEEM France ANSMFranceJun 5Optimizing Cleaning Processes in Personal Care: Matching Detergents to Residue Types for Maximum Efficiency.A3P France ANSMFranceJun 4Résultats 2026 du baromètre 360° de l’attractivité de la France pour l’industrie pharmaceutiqueLEEM France ANSMFranceJun 4Le Leem dévoile son Plan Compétences Biotech 2030 à l’occasion de la JNBB 2026LEEM France ANSMFranceMay 293ème édition de la Journée Nationale de la Bioproduction de Biomédicaments : Le Leem se mobilise pour valoriser l’innovation française au service de la compétitivitéLEEM France ANSMFranceMay 28Les aidants en entreprise : le secteur pharmaceutique poursuit son engagement auprès des salariésLEEM France ANSMFranceMay 26Thérapies ciblées et anticorps : une vague d’innovations sans précédent arrive sur le marché… l’Europe saura-t-elle en faire bénéficier les patients ?LEEM France ANSMFranceMay 21Freddy Sertin nommé Directeur des affaires publiques du Leem au sein de la Direction de l’engagementLEEM France ANSMFranceMay 19Recherche clinique : face à une dynamique mondiale sous tension, la France doit ‘transformer l’essai’LEEM France ANSMFranceMay 11Le Leem finalise sa nouvelle gouvernance avec l’élection de son 36ème administrateurLEEM France ANSMFranceMay 7Data et prospective - Economie du médicament 2025LEEM France HSA (Singapore)SingaporeJul 2315 July 2026Traditional herbal remedies - quality and safety mattersProduct typeTraditional medicinesConsumer Safety ArticlesHSA (Singapore)HSA (Singapore)SingaporeJul 2310 July 2026Recall of Remethan 100 R Tablet 100 mgAudiencesHealthcare professionalProduct typeTherapeutic ProductsRetail-level recall of one batch of Remethan 100 R Tablet 100 mg due to out-of-specification results in stability batchesProduct RecallsHSA (Singapore)HSA (Singapore)SingaporeJul 2314 July 2026Recall of Decondine SyrupAudiencesHealthcare professionalProduct typeTherapeutic ProductsRetail-level recall of all batches of Decondine Syrup, containing pseudoephedrine and triprolidine, within expiry due to out-of-specification results for triprolidine assay, pH and viscosityProduct RecallsHSA (Singapore)HSA (Singapore)SingaporeJul 2317 July 2026Recall of BD ChloraPrep™ 1 mL Applicator – Clear (17 July 2026)AudiencesHealthcare professionalProduct typeTherapeutic ProductsRetail-level recall of seven batches of BD ChloraPrep™ 1 mL Applicator – Clear due to potential breach of sterility in the packaging.Product RecallsHSA (Singapore)HSA (Singapore)SingaporeJul 2315 July 2026How health supplements are regulated by HSAProduct typeHealth supplementsConsumer Safety ArticlesHSA (Singapore)HSA (Singapore)SingaporeJul 2315 July 2026Getting savvy with health supplementsProduct typeHealth supplementsConsumer Safety ArticlesHSA (Singapore)HSA (Singapore)SingaporeJul 2323 July 20263 Consumers, Including a 12-Year-Old, Experienced Serious Adverse Effects After Taking Products with Banned or Potent Medicinal IngredientsAudiencesConsumerHealthcare professionalIndustry memberProduct typeChinese Proprietary MedicinesHealth supplementsPress ReleasesHSA (Singapore)HSA (Singapore)SingaporeJul 171 July 2026Stakeholder Consultation on the Proposed Regulation for Complementary Health Products under the Health Products ActAudiencesConsumerHealthcare professionalIndustry memberProduct typeHealth supplementsHomeopathic medicinesTraditional medicinesPublic ConsultationsHSA (Singapore)HSA (Singapore)SingaporeJul 1530 June 2026Regulatory Update for Therapeutic Product Registration (30 June 2026)AudiencesIndustry memberProduct typeTherapeutic ProductsExtension of e-labelling to P and GSL medicinesRegulatory UpdatesHSA (Singapore)HSA (Singapore)SingaporeJul 1415 June 2026Recall of BD ChloraPrep™ 1 mL Applicator – ClearAudiencesHealthcare professionalProduct typeTherapeutic ProductsRetail-level recall of four batches of BD ChloraPrep™ 1 mL Applicator – Clear due to potential breach of sterility in the packagingProduct RecallsHSA (Singapore)HSA (Singapore)SingaporeJul 1429 June 2026Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innovation as a Catalyst for Global Medtech Growth" for Singapore Medical Device Venture ShowcaseAudiencesConsumerHealthcare professionalIndustry memberSpeechesHSA (Singapore)HSA (Singapore)SingaporeJul 911 June 2026Mean applicant screening response timeAudiencesIndustry memberProduct typeTherapeutic ProductsHSA’s target screening turn-around-time from the date of receipt of the application dossier to the date of acceptance or non-acceptance/withdrawal of the application (excluding applicant’s response time) is 50 working days (WD).Regulatory UpdatesHSA (Singapore)HSA (Singapore)SingaporeJul 916 June 2026Healthpoints and Yuu PointsA concise summary of the main points regarding this article.Feature ArticlesHSA (Singapore)WHO AFROAfricaJul 2324 July 2026 News ReleaseWHO joins Uganda to celebrate 90 years of the Uganda Virus Research InstituteWHO AFRO WHO AFROAfricaJul 21Emergency21 July 2026 Feature StoryUganda safeguards essential health services during Ebola outbreak responseWHO AFRO WHO AFROAfricaJul 2122 July 2026 News ReleaseMozambique launches Action Plan for Child Survival and reaffirms its commitment to reduce child mortalityWHO AFRO WHO AFROAfricaJul 17Barefoot doctors bring health care closer to communities in EritreaWHO AFRO WHO AFROAfricaJul 16Uganda begins countdown to end of Ebola outbreakWHO AFRO CDSCOIndiaJul 23M/s. Unimax Chemicals Pvt. Ltd. (Private Limited) – Erythromycin Base BP/USP/EP and 2 itemsCDSCO India CDSCOIndiaJul 23Vigilance on imported cosmetics products sold in the domestic market without valid lmport Registration certificateCDSCO India CDSCOIndiaJul 22Clarification regarding submission of applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.CDSCO India CDSCOIndiaJul 21M/s. Honour Lab Limited, – Tedizolid Phosphate IHCDSCO India CDSCOIndiaJul 21M/s. Ravi Biolife Private Limited, – Methotrexate Disodium IH and 8 itemsCDSCO India CDSCOIndiaJul 21M/s. Endoc Biotech Private Limited – Mupirocin IP/BP/EP/USPCDSCO India CDSCOIndiaJul 21M/s. Shodhana Laboratories Private Limited, – Etofenamate Ph.Eur. and 16 itemsCDSCO India CDSCOIndiaJul 21M/s. Nira Life Sciences Pvt. Ltd. – Clonixin Lysinate IÐ and 4 itemsCDSCO India CDSCOIndiaJul 21M/s. Lewens Labs Pvt. Ltd. – Levodropropizine EP and 3 itemsCDSCO India CDSCOIndiaJul 21Guidance document on Medical Device Software under MDR-2017CDSCO India CDSCOIndiaJul 17M/s. Titan Pharmaplus Pvt Ltd. – Carbocisteine Ph. Eur. and Eltrombopag Olamine IHCDSCO India CDSCOIndiaJul 17M/s. Megafine Pharma (P) Ltd. – Donepezil Hydrochloride Monohydrate Ph. Eur. and 4 itemsCDSCO India CDSCOIndiaJul 17M/s. Hetero Labs Limited, Unit-IX – Abacavir Sulphate USP and 12 itemsCDSCO India CDSCOIndiaJul 17M/s. Elixir Pharma Chem Private Limited, – Glibenclamide BP and 2 itemsCDSCO India CDSCOIndiaJul 17M/s. Kadamb Pharmachem, – Valproic Acid BP/IP and 2 itemsCDSCO India CDSCOIndiaJul 16M/s. Kevy's Generics Private Limited – Escitalopram Oxalate IP/EP/USP and Carvedilol IP/EP/USPCDSCO India CDSCOIndiaJul 15M/s. Haleos Labs Limited – Cimetidine USP and 11 itemsCDSCO India CDSCOIndiaJul 13M/s. Andhra Organics Limited – Sulfadiazine BP/ Ph.Eur /USP and 3 itemsCDSCO India CDSCOIndiaJul 13M/s. Lifecare Laboratories Private Limited – Biperiden Hydrochloride Ph.EurCDSCO India CDSCOIndiaJul 6Inviting comments on consideration of the proposal regarding Issue of use of brand name extensions by the pharmaceutical firmsCDSCO India CDSCOIndiaJul 3M/s. Neuland Laboratories Ltd, Unit-I, – Rotigotine Ph.Eur and 27 itemsCDSCO India CDSCOIndiaJul 3M/s Zentiva Private Limited – Trimecaine Hydrochloride IH and 9 itemsCDSCO India CDSCOIndiaJul 3M/s. Optimus Drugs Private Limited. – Apixaban IHS and 19 itemsCDSCO India CDSCOIndiaJul 3M/s. Bal Pharma Ltd, – Ebastine BP/EP and Gliclazide BP/EPCDSCO India CDSCOIndiaJul 3M/s. Melody Healthcare Pvt. Ltd. – Perindopril Arginine IH and 20 itemsCDSCO India CDSCOIndiaJul 2List of new drugs approved in the year 2001CDSCO India CDSCOIndiaJul 1m/s. Alivus Life Sciences Limited – Olopatadine Hydrochloride USP and 56 itemsCDSCO India CDSCOIndiaJun 25M/s. Valens Molecules Private Limited – Sulfamethizole BP/Ph.Eur. and Sulfasalazine BP/USP/Ph.EurCDSCO India CDSCOIndiaJun 24Sale of In-Vitro Fertilization media, reagents and related consumables used in Assisted Reproductive Technology proceduresCDSCO India CDSCOIndiaJun 24Regulation of Formulation intermediates such as Directly Compressible granules, Taste masked granules, Modified release granules / PelletsCDSCO India CDSCOIndiaJun 24Submission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM PortalCDSCO India CDSCOIndiaJun 24Sale of In-Vitro Fertilization media, reagents and related consumables used in Assisted Reproductive Technology proceduresCDSCO India CDSCOIndiaJun 19M/s.Neuland Laboratories Ltd – Bempedoic acid IH and 3 itemsCDSCO India CDSCOIndiaJun 17M/s Shakti Lifescience Private Limited, – Abiraterone Acetate USP and 8 itemsCDSCO India CDSCOIndiaJun 16M/s Cohance Lifesciences Limited, – Levomepromazine Maleate EP/BPCDSCO India CDSCOIndiaJun 16M/s. Vasudha Pharma Chem Limited, – Aripiprazole Ph.Eur and 23 itemsCDSCO India CDSCOIndiaJun 16M/s Alembic Pharmaceuticals Limited – Pinaverium Bromide IH and 52 itemsCDSCO India CDSCOIndiaJun 16Constitution of Consultancy Committee of Key Stakeholders for Advice on Suo-Motu Disclosure under Section 4 of the RTI Act, 2005 in CDSCOCDSCO India CDSCOIndiaJun 16M/s. Ravi Biolife Private Limited – Methotrexate EP/USPCDSCO India CDSCOIndiaJun 16M/s Themis Medicare (l) Ltd – Ketamine Hydrochloride IP/BP/USPCDSCO India CDSCOIndiaJun 11Submission of Compliance for lmported/manufactured Hair Color Cosmetics Products as per Cosmetics Rules, 2020 and applicable BIS StandardsCDSCO India CDSCOIndiaJun 9M/s. Srikem Laboratories Pvt. Ltd. – Cyclizine ÐÐ and 11 itemsCDSCO India CDSCOIndiaJun 9Brief note on Two Days workshop on Medical Devices Frameworks organized by Danish Medical Agency (DKMA)- CDSCO on 8-9 April 2026CDSCO India CDSCOIndiaJun 9M/s. Srikem Laboratories Pvt. Ltd – Cyclizine ÐÐ and 11 itemsCDSCO India CDSCOIndiaJun 5M/s. Sohan Healthcare Pvt. Ltd – Gliclazide BP/IP/JP/Ph.Eur and 3 itemsCDSCO India CDSCOIndiaJun 3Transfer List 2025CDSCO India CDSCOIndiaJun 3Implementation of Pharmacovigilance (PV) System as per the requirement of Schedule M of Drugs & Cosmetics Act 1940 and the Rules made there underCDSCO India CDSCOIndiaJun 2M/s. Mahi Drugs Private Limited – Albendazole USP/ Ph. Eur and 8 itemsCDSCO India CDSCOIndiaJun 2M/s. Livmore Life Sciences Pvt. Ltd. – Benfotiamine IÐ and 8 itemsCDSCO India CDSCOIndiaJun 1M/s Cohance Lifesciences Limited, – Thiabendazole USP and 28 itemsCDSCO India CDSCOIndiaMay 26Revised Regulatory Guidelines For Sampling Of Drugs, Cosmetics & Medical Devices By Drugs Inspectors Of Central & State Drug AuthoritiesCDSCO India CDSCOIndiaMay 26Regulatory Guidelines For Sampling Of Drugs, Cosmetics & Medical Devices By Drugs Inspectors Of Central & State Drug AuthoritiesCDSCO India CDSCOIndiaMay 25M/s. Suleshvari Pharma – Famotidine BP/USP/EP and Sevelamer Carbonate IHCDSCO India CDSCOIndiaMay 25M/s Farmson Basic Drugs Pvt Ltd. (Unit-II) – Paracetamol IP/BP/Ph.Eur/JP and Acetaminophen USPCDSCO India CDSCOIndiaMay 19M/s. Vaasavaa Pharmaceuticals Pvt Ltd, – Famotidine EP/BP/USP and Sertraline Hydrochloride EP/BP/USPCDSCO India CDSCOIndiaMay 13M/s Quad Lifesciences Ltd. – Colchicine Ph.Eur and 3 itemsCDSCO India CDSCOIndiaMay 13M/s Aurore Life Sciences Private Limited, – Aciclovir Ph. Eur. and 12 itemsCDSCO India CDSCOIndiaMay 13M/s Lucent Drugs Private Limited, – Tramadol Hydrochloride USP/BP/IP/Ph. Eur.CDSCO India CDSCOIndiaMay 13M/s Lifecare Laboratories Pvt. Ltd, – Dexmedetomidine Hydrochloride USPCDSCO India CDSCOIndiaMay 13Restriction on shifting/reallocation of IT equipment without prior intimation and approval of Administration and IT cell of CDSCO(HQ)CDSCO India SAHPRASouth AfricaJul 20SAHPRA Inspires Rhodes Science Students to Shape the Future of Health RegulationSAHPRA South Africa SAHPRASouth AfricaJul 20SAHPRA Inspires Rhodes Science Students to Shape the Future of Health RegulationSAHPRA South Africa SAHPRASouth AfricaJul 8Health regulators warn against the use or dispensing of recalled Semaglutide and TirzepatideSAHPRA South Africa SAHPRASouth AfricaJul 8Health regulators warn against the use or dispensing of recalled Semaglutide and TirzepatideSAHPRA South Africa SAHPRASouth AfricaJul 8Health regulators warn against the use or dispensing of recalled Semaglutide and TirzepatideSAHPRA South Africa SAHPRASouth AfricaJun 25Protecting Patients: Ensuring Safe, Quality and Effective Health ProductsSAHPRA South Africa SAHPRASouth AfricaJun 25Protecting Patients: Ensuring Safe, Quality and Effective Health ProductsSAHPRA South Africa SAHPRASouth AfricaJun 4SAHPRA strengthens industry collaboration to improve access to safe medicinesSAHPRA South Africa SAHPRASouth AfricaJun 4SAHPRA strengthens industry collaboration to improve access to safe medicinesSAHPRA South Africa SAHPRASouth AfricaMay 23SAHPRA and the SAPC Crack Down on Unlawful Manufacturing of Unregistered GLP-1/ GIP MedicinesSAHPRA South Africa SAHPRASouth AfricaMay 23SAHPRA and the SAPC Crack Down on Unlawful Manufacturing of Unregistered GLP-1/ GIP MedicinesSAHPRA South Africa SAHPRASouth AfricaMay 23SAHPRA and the SAPC Crack Down on Unlawful Manufacturing of Unregistered GLP-1/ GIP MedicinesSAHPRA South Africa CBG-MEB NetherlandsNetherlandsJul 14Sinaspril Stroop alleen geschikt vanaf 5 jaarHet paracetamol drankje Sinaspril Stroop bevat de hulpstoffen propyleenglycol en alcohol. Bij jonge kinderen kunnen deze stoffen ...14-07-202614:00Lees verderCBG-MEB Netherlands CBG-MEB NetherlandsNetherlandsJul 14Gebruik Ixchiq-vaccin alleen bij personen die een hoog risico lopen op de ziekte chikungunyaHet Chikungunya-vaccin Ixchiq kan in zeer zeldzame gevallen ernstige bijwerkingen veroorzaken, waaronder ontsteking van de ...14-07-202610:00Lees verderCBG-MEB Netherlands APACMedSingaporeJul 13Guidebook on Channel Partner Training – Medical Devices (India)APACMed APACMedSingaporeJun 9RA Committee Townhall – How Agentic AI is Redefining Regulatory ExcellenceAPACMed APACMedSingaporeJun 2When Regulators Use AI: What It Means for MedTech TeamsAPACMed APACMedSingaporeMay 18From Concept To Practice: Advancing Regulatory Reliance For Medical DevicesAPACMed BASG AustriaAustriaJul 10CHMP Meeting Highlights Mai 2026BASG Austria BASG AustriaAustriaJul 8Sicherheitsinformation - Unbefugter Vertrieb der Chargen 1725204004 und 1725069002 durch Dritte / Dexcom G7-SensorBASG Austria BASG AustriaAustriaJul 7Litalir 500 mg – Kapseln (Paralleldistribution EMRA-MED Arzneimittel GmbH)BASG Austria DKMADenmarkJul 3Register-based study suggests a slightly increased risk of meningiomas in women using hormonal contraception containing a progestogenDanish Medicines Agency DKMADenmarkJun 29Are you running clinical trials? You can now activate e-mail notifications in CTISDanish Medicines Agency DKMADenmarkJun 25Are you working with cell therapy and planning a clinical trial?Danish Medicines Agency DKMADenmarkJun 9The guidance on digital and decentralised clinical trials (DCT) has been updatedDanish Medicines Agency DKMADenmarkMay 22EMA’s Human Medicines Committee Recommends Wegovy in Tablet FormDanish Medicines Agency DKMADenmarkMay 20Remember to monitor deadlines in CTIS during the summer periodDanish Medicines Agency DKMADenmarkMay 7The Danish Medicines Agency will be closed on Friday 15 May 2026Danish Medicines Agency DKMADenmarkMay 7Operation Pangea XVIII: Global action against falsified medicines and illicit tradeDanish Medicines Agency SAM EstoniaEstoniaJul 1New Medical Devices and Appliances Database (EMDDB) launches next weekSAM Estonia SAM EstoniaEstoniaJun 8Training on the use of the new version of the Estonian Medical Devices and Appliances DatabaseSAM Estonia SAM EstoniaEstoniaMay 29The Estonian medicinal products market in the first quarter 2026SAM Estonia SAM EstoniaEstoniaMay 25Estonian State Agency of Medicines Among Europe’s BestSAM Estonia SAM EstoniaEstoniaMay 14Disruptions may occur when sending e-mails to State Agency of Medicines contactsSAM Estonia SwissmedicSwitzerlandJun 30Cross-agency targeted campaign “Peptides 2026”Swissmedic Official News SwissmedicSwitzerlandJun 12Swissmedic publishes its Annual Report and financial statements for 2025Swissmedic Official News IMA IcelandIcelandJun 18Minimum service from 20 July till 3 AugustIMA Iceland IMA IcelandIcelandMay 15A new tariff for fees has come into effectIMA Iceland Arab Pharma ManufacturersMENAJun 7ملتقى الصناعات الصيدلانية العربية التاسع والعشرينArab Pharma Manufacturers