Pipeline and approval signals
Search agency notices, approvals, recalls, and regulatory updates from global authorities.
Showing 815 of 815 tracked regulatory updates from 31 agencies.
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment StudyNA | NOT_YET_RECRUITING | University of North Carolina, Chapel HillClinicalTrials.govNeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic StrokePhase 4 | RECRUITING | EVD Pharmacy and Medical Company Limited | MLC901ClinicalTrials.govEffect of Agave Consumption on Performance and Gut Microbiota in Adults Undergoing Physical TrainingNA | ENROLLING_BY_INVITATION | National Polytechnic Institute, MexicoClinicalTrials.govClinical Performance and Failure Rates of Restorations Following Pediatric Dental Rehabilitation Under General AnesthesiaN/A | RECRUITING | Tanta UniversityClinicalTrials.govA Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During TreatmentPhase 3 | NOT_YET_RECRUITING | Hoffmann-La Roche | GiredestrantClinicalTrials.govBacillus Probiotics With Bismuth Quadruple Therapy for Helicobacter Pylori InfectionNA | NOT_YET_RECRUITING | Anabio R&DClinicalTrials.govEffectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired AdultsNA | RECRUITING | The Hong Kong Polytechnic UniversityClinicalTrials.govA multicentre, single-arm, open-label, non-randomised pilot clinical trial to assess the dose-dependent effect of tirzepatide on gastric emptying in adult patients with type 1 diabetesHuman Pharmacology (Phase I)- Other | Authorised, recruitment pending | Fundacion Para La Investigacion Biomedica Del Hospital Universitario Ramon Y CajalClinicalTrials.govA Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily oral ASC30 in Adult Participants with Obesity or Overweight with Weight-Related Comorbidities (AURORA-1)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Ascletis Pharma (China) Co. Ltd. | ASC30 | Asc30 placebo tablets a1 (oval-shaped tablets) | Asc30 placebo tablets a1 (round biconvex tablets)ClinicalTrials.govAn Open-Label, Controlled, Multiple-Dose Phase I Clinical Trial Evaluating the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of SHR-3167 in Subjects With Type 2 DiabetesHuman Pharmacology (Phase I)- Other | Authorised, recruitment pending | Jiangsu Hengrui Pharmaceuticals Co. Ltd.ClinicalTrials.govMulticentre, randomized, open label study comparing the concomitant administration of trabectedin and low-dose radiotherapy versus trabectedin alone in patients with advanced sarcomaTherapeutic use (Phase IV) | Authorised, recruitment pending | Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz | TRABECTEDINClinicalTrials.govA Multicentre, Parallel-Group, Observer-Blind, Randomised, Placebo-Controlled, Pivotal Trial Investigating the Safety and Immunogenicity of Group B Streptococcus Vaccine (GBS-NN/NN2) in Pregnant Women and Infants Born to Pregnant Women Vaccinated During PregnancyPhase II and Phase III (Integrated) | Authorised, recruitment pending | Minervax ApS | 0.9% sodium chloride | GBS-NN/NN2ClinicalTrials.govAntibiotic Prophylaxis in Hematopoietic Stem Cell Transplantation: a Randomised Controlled Trial - The ANTURA trialTherapeutic use (Phase IV) | Authorised, recruitment pending | HUS-yhtymae | Levonic 5 mg/ml infuusioneste | liuos | Natriumklorid Baxter Viaflo 9 mg/mlClinicalTrials.govA Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults with Idiopathic Pulmonary Fibrosis (SURPASS-IPF)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Puretech Lyt 100 Inc. | Deupirfenidone (LYT-100) | Pirfenidone Zentiva 267 mg compresse rivestite con filmClinicalTrials.govA Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)Therapeutic exploratory (Phase II) | Authorised, recruitment pending | Corvus Pharmaceuticals Inc. | Placebo tablets | SoquelitinibClinicalTrials.govA Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian CancerTherapeutic confirmatory (Phase III) | Authorised, recruitment pending | Genmab A/S | Paclitaxel 6 mg/ml Concentrate for Solution for Infusion | Carboplatin 10 mg/ml concentrate for solution for infusion | Ziextenzo 6 mg solution for injection in pre-filled syringeClinicalTrials.govA Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination with the Modified Gemcitabine and nab-Paclitaxel Regimen Versus the Standard Gemcitabine and nab-Paclitaxel Regimen for the Treatment of Patients with Metastatic Pancreatic Ductal Adenocarcinoma Cancer (MAPKeeper 301)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Immuneering Corp. | GEMCITABINE | PACLITAXEL | AtebimetinibClinicalTrials.govA Long-Term Follow-Up Study of Subjects Completing the AU-011-301 (CoMpass) Trial of Bel-sar for Early Choroidal Melanoma (Indeterminate Lesions/Small Choroidal Melanomas)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Aura Biosciences Inc. | BELZUPACAP SAROTALOCAN | Placebo (sham injection) to Belzupacap Sarotalocan solution for sham injection 0.0 mg/mlClinicalTrials.govA Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator’s Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy.Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Janssen Cilag International | Lenalidomide Mylan 20 mg hard capsules | Dexamethason 8 mg GALEN Tabletten | Lenalidomide Mylan 25 mg hard capsulesClinicalTrials.govZenagamtide use for the reduction of risk of major adverse cardiovascular events in people with established atherosclerotic cardiovascular disease and either overweight or obesity (AMBIENCE)Therapeutic confirmatory (Phase III) | Authorised, recruitment pending | Novo Nordisk A/S | NNC0487-0111 B 10143 | NNC0487-0111 B 10141 | NNC0487-0111 B 10144ClinicalTrials.govA phase II randomised trial investigating the benefit of adjuvant immunotherapy after neoadjuvant chemoimmunotherapy for resectable NSCLC (ADIL)Therapeutic exploratory (Phase II) | Authorised, recruitment pending | Oslo Universitetssykehus HF | IMFINZI 50 mg/mL concentrate for solution for infusionClinicalTrials.govPlacebo Effect on Cycling Performance: Laboratory Crossover StudyNA | NOT_YET_RECRUITING | Poznan University of Physical Education | Caffeine (6mg/kg)ClinicalTrials.govAutonomic and Peripheral Neurochemical Responses to Maximal Rowing ExerciseN/A | COMPLETED | Poznan University of Physical EducationClinicalTrials.govFirST Lines of Biologics in pAtients With ulceRaTivE Colitis: a Randomised Controlled TrialPhase 4 | NOT_YET_RECRUITING | University Hospital, Clermont-Ferrand | 1: infliximab 2: filgotinib 3: ustekinumab 4: vedolizumab | 1: ustekinumab 2: vedolizumab 3: infliximab 4: filgotinib | 1: vedolizumab 2: infliximab 3: filgotinib 4: ustekinumabClinicalTrials.govEffectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive BladderNA | RECRUITING | SEZGINClinicalTrials.govNanopulse Laser TherapyPhase 1 | NOT_YET_RECRUITING | The University of Texas Medical Branch, GalvestonClinicalTrials.govA Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)Phase 3 | RECRUITING | Novartis Pharmaceuticals | Pelabresib | Ruxolitinib | PlaceboClinicalTrials.govNBTXR3 With Radiation Therapy Alone for Locally-advanced Non-small Cell Lung CancerPhase 1 | RECRUITING | M.D. Anderson Cancer Center | NBTXR3ClinicalTrials.govBeginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of CarePhase 3 | RECRUITING | GT Medical Technologies, Inc. | TemozolomideClinicalTrials.govPredictive Biomarkers for PD-1 Inhibitor Response in Squamous Cell CarcinomaN/A | ACTIVE_NOT_RECRUITING | Cancer Institute and Hospital, Chinese Academy of Medical SciencesClinicalTrials.govEvaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in PakistanNA | COMPLETED | Global Institute of Human DevelopmentClinicalTrials.govFeasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot StudyPhase 1 | RECRUITING | M.D. Anderson Cancer CenterClinicalTrials.govEffects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical TrialNA | RECRUITING | National Institute on Aging (NIA)ClinicalTrials.govA Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDDPhase 2 | COMPLETED | Gilgamesh Pharmaceuticals | GM-2505ClinicalTrials.govEvaluation of Performance and Safety of Eye Drops With Hyaluronic Acid 0.30% and 0.15%NA | COMPLETED | Fidia Farmaceutici s.p.a.ClinicalTrials.govTesting the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)Phase 2 | RECRUITING | National Cancer Institute (NCI) | Neratinib Maleate | PalbociclibClinicalTrials.govDetermination of a Minimal Clinically Important Difference of the "Functional Reach Test" in the Elderly.N/A | COMPLETED | Pole Sante Grace de DieuClinicalTrials.govMR Evidence of Cardiac Inflammation Post-StrokeN/A | RECRUITING | Luciano A. SposatoClinicalTrials.govDECIDE: Dyads and FamiliesNA | WITHDRAWN | Emory UniversityClinicalTrials.govA follow-up extension study of patients who completed the U-LaserPrint-1 clinical trial to evaluate the long-term safety and efficacy of treatment with InvivoLPrint-U.Phase I and Phase II (Integrated)- First administration to humans | Authorised, recruitment pending | Phosprint S.A. | aUroCell-TxClinicalTrials.govPRIMAQUINE PHOSPHATEPRIMAQUINE PHOSPHATE | ANDA | AP | ALVOGENFDAITRACONAZOLEITRACONAZOLE | ANDA | AP | ALEMBICFDACLOBAZAMCLOBAZAM | ANDA | AP | MICRO LABSFDAPRIMAQUINE PHOSPHATEPRIMAQUINE PHOSPHATE | ANDA | AP | UNICHEMFDAITRACONAZOLEITRACONAZOLE | ANDA | AP | AMNEAL PHARMSFDADOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATE | ANDA | AP | CHANGZHOU PHARMFDAEPINEPHRINEEPINEPHRINE | ANDA | AP | ZYDUS PHARMSFDACOLISTIMETHATE SODIUMCOLISTIMETHATE SODIUM | ANDA | AP | SAGENT PHARMS INCFDAPOLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350 | ANDA | AP | STRIDES PHARMAFDACARBIDOPA AND LEVODOPACARBIDOPA | ANDA | AP | SUN PHARM INDSFDAPACLITAXELPACLITAXEL | ANDA | AP | TEVA PHARMSFDAKYBELLADEOXYCHOLIC ACID | NDA | AP | ABBVIEFDADASATINIBDASATINIB | ANDA | AP | MSNFDACARBIDOPA AND LEVODOPACARBIDOPA | ANDA | AP | ACTAVIS ELIZABETHFDAPIXCLARAFLORETYROSINE F 18 | NDA | AP | TELIX PHARMACEUTICALS US INCFDAJOENJALENIOLISIB PHOSPHATE | NDA | AP | PHARMINGFDAIMDELLTRATARLATAMAB-DLLE | BLA | AP | AMGEN INCFDAITRACONAZOLEITRACONAZOLE | ANDA | AP | APOTEXFDAGABAPENTINGABAPENTIN | ANDA | AP | INVAGEN PHARMSFDAISEMBYLDAPITEGROMAB-MSTN | BLA | AP | SCHOLAR ROCK INCFDAANNOVERAETHINYL ESTRADIOL | NDA | AP | MAYNE PHARMAFDAISOTRETINOINISOTRETINOIN | ANDA | AP | AUROBINDO PHARMA LTDFDALISDEXAMFETAMINE DIMESYLATELISDEXAMFETAMINE DIMESYLATE | ANDA | AP | ASCENT PHARMS INCFDAASENAPINE MALEATEASENAPINE MALEATE | ANDA | AP | ALEMBICFDASPIRONOLACTONE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE | ANDA | AP | RUBICON RESEARCHFDAROPINIROLE HYDROCHLORIDEROPINIROLE HYDROCHLORIDE | ANDA | AP | ALEMBIC LTDFDAAMELUZAMINOLEVULINIC ACID HYDROCHLORIDE | NDA | AP | BIOFRONTERAFDAHYRNUOSEVABERTINIB | NDA | AP | BAYER HEALTHCAREFDABRIVARACETAMBRIVARACETAM | ANDA | AP | ZHEJIANG JUTAI PHARMFDACONSULTA PÚBLICA REQUERIMIENTOS TÉCNICOS ADMINISTRATIVOSConsejo Superior de Salud Pública (El Salvador)Licenciaturas en El SalvadorConsejo Superior de Salud Pública (El Salvador)Jornada de carnetización para profesionales y trámites de Establecimientos de SaludConsejo Superior de Salud Pública (El Salvador)Lanzamiento de la app DoctorSV para atención médica virtualConsejo Superior de Salud Pública (El Salvador)Acto de juramentación de nuevos miembros del Consejo Directivo y Junta de VigilanciasConsejo Superior de Salud Pública (El Salvador)Acto de juramentación de nuevos miembros del Consejo Directivo y Junta de VigilanciasConsejo Superior de Salud Pública (El Salvador)Programa Anual de Regulación de Establecimientos de Salud del Sector Privado 2026Consejo Superior de Salud Pública (El Salvador)Elecciones de Juntas de Vigilancia y Consejo Directivo 2026Consejo Superior de Salud Pública (El Salvador)Procesos de Compras UCPConsejo Superior de Salud Pública (El Salvador)Curso de Legislación Laboral aplicada a la Regencia de Servicios de SaludConsejo Superior de Salud Pública (El Salvador)SAHPRA Reinforces Its Commitment to Radiation Safety at IAEA General ConferenceSAHPRA South AfricaSAHPRA and Lesotho strengthen regional collaboration for regulatory excellenceSAHPRA South AfricaSouth Africa Maintains WHO Maturity Level 3 (ML3) for Vaccine RegulationSAHPRA South AfricaSAHPRA Reaffirms the Safety of Routine Childhood VaccinationSAHPRA South AfricaAngiotensin-Converting Enzyme Inhibitor-Induced Angioedema: Risk of Serious and Fatal OutcomesSAHPRA South AfricaSAHPRA inspires TUT students to pursue careers in health regulationSAHPRA South AfricaSAHPRA recalls certain batches of Enalapril 10mg Arya Commonly used to treat high blood pressureSAHPRA South AfricaSAHPRA Inspires Rhodes Science Students to Shape the Future of Health RegulationSAHPRA South AfricaHealth regulators warn against the use or dispensing of recalled Semaglutide and TirzepatideSAHPRA South AfricaHealth regulators warn against the use or dispensing of recalled Semaglutide and TirzepatideSAHPRA South AfricaProtecting Patients: Ensuring Safe, Quality and Effective Health ProductsSAHPRA South AfricaGuidance: COVID-19 test validation approved productsMHRA UKDecision: Marketing authorisations Granted in 2026MHRA UKDecision: Parallel import licences granted in 2026MHRA UKMHRA consultation on statutory fees (2026)MHRA UKHexavalent combination vaccine: programme guidanceUK Health Security AgencyFlu vaccination in the social care sectorUK Health Security AgencyMeasuring excess mortality: a guide to the main reportsUK Health Security AgencyHigh consequence infectious disease: country specific riskUK Health Security AgencyEbola and Marburg haemorrhagic fevers: outbreaks and case locationsUK Health Security AgencyOutbreaks under monitoring in 2026UK Health Security AgencyWorking for DHSCUK Department of Health and Social CareWeekly all-cause mortality surveillance: week ending 20 September 2026UK Health Security AgencyMinister of State for Social Care and Mental Health speech on dementiaUK Department of Health and Social CareChair appointed to lead Tees, Esk and Wear Valleys Trust inquiryUK Department of Health and Social CareWeekly all-cause mortality surveillance: 2026 to 2027UK Health Security AgencySyndromic surveillance: weekly summaries for 2026UK Health Security AgencyRemote health advice: weekly bulletins for 2026UK Health Security AgencyNational ambulance syndromic surveillance: weekly bulletins 2026UK Health Security AgencyGP out-of-hours syndromic surveillance: weekly bulletins for 2026UK Health Security AgencyGP in-hours: weekly bulletins for 2026UK Health Security AgencyEmergency department: weekly bulletins for 2026UK Health Security AgencyRadiofrequency (RF) Safety Considerations for Wireless Cardiotocography (CTG) Monitoring Systems (DSI/2026/012)MHRA UKClass 4 Medicines Defect Notification: Martindale Pharmaceuticals Ltd, Clobazam Martindale Pharma 5 mg/5 mL and 10 mg/5 mL Oral Suspension 150ml, EL(26)A/38MHRA UKCOVID-19 vaccination: autumn programme resourcesUK Health Security AgencyChildren’s public health nursing: workforce and activity, 2025UK Department of Health and Social CareMeasles epidemiology 2023 to 2026UK Health Security AgencyEnvironmental monitoring following the Grenfell Tower fireUK Health Security AgencySalmonella outbreak updateUK Health Security AgencyBioscience and health technology sector statistics 2024 to 2025UK Department of Health and Social CareSalmonella statistical releasesUK Health Security AgencyBioscience and health technology sector statisticsUK Department of Health and Social CareMigrant health guideUK Health Security AgencyImmunisation patient group direction (PGD) templatesUK Health Security AgencyLegionellosis in residents of England and Wales: 2025UK Health Security AgencyCold mortality monitoring report, England: winter 2024 to 2025UK Health Security AgencyEstates Safety Fund: initial schemes and associated funding allocations, 2026 to 2030UK Department of Health and Social CareCOVID-19 vaccination: information for healthcare practitionersUK Health Security AgencyPre-submission Advice & Support for Innovative MedicinesMHRA UKNational assessment procedure for medicinesMHRA UKMedicines: apply for a variation to your marketing authorisationMHRA UKNotifiable diseases: causative agents reports for 2026UK Health Security AgencyCOVID-19 vaccine (5 years and over) PGD and VGDUK Health Security AgencyCOVID-19: the green book chapterUK Health Security AgencyMHRA sets out steps to prevent avoidable harm from patient hoistsMHRA UKOpportunities for patients and the public to be involved in the work of the MHRAMHRA UKGuidance: National Patient Safety Alert Supporting Information. Patient hoists and slings: incidents and case examples.MHRA UKNational Patient Safety Alert: Patient hoists and slings (all types): risk of death and serious harm from falls (NatPSA/2026/005/MHRA)MHRA UKSix neighbourhood health trailblazers to transform careUK Department of Health and Social CareBeyond ADMET: AI for medicines safety stakeholder surveyMHRA UKClinical trials for medicines: Good clinical practice inspectionsMHRA UKSex ratios at birth in the UK: 2019 to 2023UK Department of Health and Social CareMigrant health: country-of-origin health protection adviceUK Health Security AgencySex ratios at birth in the UK: 2018 to 2022UK Department of Health and Social CareSTI quarterly surveillance reports: provisional dataUK Health Security AgencyUK Clinical Research Delivery key performance indicatorsUK Department of Health and Social CareUK Clinical Research Delivery key performance indicators: data to August 2026UK Department of Health and Social CareBovine tuberculosis (TB): public health managementUK Health Security AgencySurvey into the Radiological Impact of the Routine Transport of Radiopharmaceuticals in the UKUK Health Security AgencyGovernment response to the Thirlwall InquiryUK Department of Health and Social CareGovernment to act on Thirlwall patient safety recommendationsUK Department of Health and Social CareCounterfeit laser hair removal and therapy devices found in some clinics and may pose serious health risksHealth Canada Recalls & AlertsSIGNA™ Artist and SIGNA™ Artist EvoHealth Canada Recalls & AlertsRAPICIDE™ PA High Level DisinfectantHealth Canada Recalls & AlertsTrinity Biotech Oxalate Reagent KitHealth Canada Recalls and Safety AlertsPhilips Ingenia, Achieva and Intera MR SystemsHealth Canada Recalls and Safety AlertsPlatinum Naturals Easymulti Stress (men): Affected lots incorrectly labelled for Vitamin B6 quantityHealth Canada Recalls and Safety AlertsNDI Passive Spheres™Health Canada Recalls and Safety AlertsIntelliSpace Critical Care And AnesthesiaHealth Canada Recalls and Safety AlertsCompliance and enforcement policy for health products (POL-0001)Health Canada Drug ProductsOrganika® Gummies: Foreign site not listed on site licenceHealth Canada Recalls and Safety AlertsRegister of Innovative DrugsHealth Canada Drug ProductsRequesting new data for review of Access Consortium work-sharing submissions: NoticeHealth Canada Drug ProductsInterim policy for the modernization of the clinical trial framework: NoticeHealth Canada Drug ProductsProposed interim approach to speed up the review of certain pediatric drugs: NoticeHealth Canada Drug ProductsWhat we heard: Consulting on modernizing clinical trialsHealth Canada Drug ProductsNotice of Compliance (NOC) Data ExtractsHealth Canada Drug ProductsTZIELD (teplizumab) and the Risk of Viral ReactivationHealth Canada Recalls and Safety AlertsProduct monograph brand safety updatesHealth Canada Drug ProductsIMN Screws System Advanced Locking ScrewHealth Canada Recalls and Safety AlertsGeneric acetaminophen by Teva recalled because it may contain foreign materialHealth Canada Recalls and Safety AlertsDxc 500i Clinical Analyzer and Dxc 500 AU Clinical Chemistry AnalyzerHealth Canada Recalls and Safety AlertsCentricity High Acuity AnesthesiaHealth Canada Recalls and Safety AlertsUpdated Register of Certificates of Supplementary Protection and ApplicationsHealth Canada Drug ProductsVeradius Unity and BV Pulsera Mobile C-Arm System-9in. and 12in. VersionsHealth Canada Recalls and Safety AlertsPhilips Ingenia, Achieva and Intera MR SystemsHealth Canada Recalls and Safety AlertsLIFEPAK ® 35 Monitor/DefibrillatorHealth Canada Recalls and Safety AlertsImager™ II Angiographic CatheterHealth Canada Recalls and Safety AlertsGORE® VIABAHN® Endoprosthesis with PROPATEN BioactiveHealth Canada Recalls and Safety AlertsDrug Product Database data extract [2026-09-03]Health Canada Drug ProductsQuantum PureFlow Standard Heat Exchanger High FlowHealth Canada Recalls and Safety AlertsLIFEPAK ® 35 Monitor/DefibrillatorHealth Canada Recalls and Safety AlertsLEO+ Intracranial Self Expandable Stent And Delivery SystemHealth Canada Recalls and Safety AlertsBiCOAG Hemostasis ProbeHealth Canada Recalls and Safety AlertsImproving how we review generic drugsHealth Canada Drug ProductsMonthly update to the submissions under review listsHealth Canada Drug ProductsMonthly update to the generic submissions under review listHealth Canada Drug ProductsJAMP Temozolomide: Out-of-Specification (Assay)Health Canada Recalls and Safety AlertsCarestation 850Health Canada Recalls and Safety AlertsBlanketrol® II 115V and Blanketrol® III 115VHealth Canada Recalls and Safety AlertsNotice: Multiple additions to the Prescription Drug List (PDL) [2026-08-27]Health Canada Prescription Drugspro+ Flat Deck Wide W/O X-RayHealth Canada Recalls and Safety AlertsCardinal Health Gynaecology Robotics and Endoscopy PacksHealth Canada Recalls and Safety AlertsAutomated Impella Controller (AIC)Health Canada Recalls and Safety AlertsApo-Semaglutide Injection : Incorrect dose displayHealth Canada Recalls and Safety AlertsInformation about the Prescription Drug List: NoticeHealth Canada Prescription DrugsMed-Rx Medication/Primary Solution Administration KitHealth Canada Recalls and Safety AlertsMaquet Percutaneous Insertion Kit and Dilator SetsHealth Canada Recalls and Safety AlertsCyanosure DermaV Laser SystemHealth Canada Recalls and Safety AlertsCARESCAPE Central StationHealth Canada Recalls and Safety AlertsBIOFIRE® Joint Infection Panel – 30 PackHealth Canada Recalls and Safety AlertsTwins Herbal Products: Undeclared prescription drug (sildenafil)Health Canada Recalls and Safety AlertsDräger VentStar® Resus Neo and VentStar® ResuscitaireHealth Canada Recalls and Safety AlertsImportation of South Korean-Authorized BONKY Injection, 1 mcg/mL Calcitriol, due to the Current Shortage of Canadian-Authorized Calcitriol Injection USP, 1 mcg/mLHealth Canada Recalls and Safety AlertsiQ200 Series Analyzers and DxU 840m/850m Iris AnalyzersHealth Canada Recalls and Safety AlertsForeSight™ Oximeter CableHealth Canada Recalls and Safety AlertsAisys™ CS² and Carestation™Health Canada Recalls and Safety AlertsTheragun PROHealth Canada Recalls and Safety AlertsPatient Information Centre iXHealth Canada Recalls and Safety AlertsCentricity™ Enterprise Archive and PACS WorkstationHealth Canada Recalls and Safety AlertsSummary Basis of Decision for EnflonsiaHealth Canada Drug ProductsMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026European Medicines AgencyMeeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026European Medicines AgencyMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026European Medicines AgencyNew EU supply chain to end Visudyne shortageEuropean Medicines AgencyVoluntary data submission pilot to advance innovative alternatives to animal testingEuropean Medicines AgencyCancer DeathsEFPIA EuropeCancer CasesEFPIA EuropeCancer Comparator Report 2025expand_moreexpand_lesschevron_rightEFPIA EuropeΑνάκληση της παρτίδας 0366002724 του Ιατροτεχνολογικού προϊόντος UR-TEST 120ml Sterile ΟυροσυλλέκτηςEOF GreeceΑπαγόρευση διάθεσης και διακίνησης του συμπληρώματος διατροφής CREATINA 5.0EOF GreeceΑπαγόρευση διάθεσης και διακίνησης των συμπληρωμάτων διατροφής CM3 CAPS, CM3 POWDER 250G PINK GRAPEFRUITEOF GreeceΑνάκληση της Άδειας Χονδρικής πώλησης φαρμάκων για Ανθρώπινη Χρήση της εταιρείας ΦΑΡΜΑ ΧΑΟΥΖ Μ.ΕΠΕEOF GreeceΟΡΘΗ ΕΠΑΝΑΛΗΨΗ_Τελικές Προτεινόμενες _ Νέα 2ου Τριμήνου 2026 _ Ανατιμολόγηση προϊόντων αναφοράς λόγω λήξης της προστασίας δεδομένων τους _ Μη Αποζημιούμενα: αναπροσαρμογή τιμήςEOF GreeceMedDRA 29.1EOF GreeceΣυμμετοχή του ΕΟΦ στην 90η ΔΕΘ.EOF GreeceΑνάκληση του αριθμού παρτίδας 14 L156 D της βρεφικής τροφής με ονομασία πώλησης “Bio/Organic Apple-Peach-Mango, 6+ months” και εμπορική ονομασία “LUPILU”EOF GreeceΑνάκληση της παρτίδας 25F1670 του Ιατροτεχνολογικού προϊόντος Gloflon I.V. CATHETER WITH INJECTION VALVES & WINGS 20G 1.1 x 33mmEOF GreeceΑνάκληση της παρτίδας 3145507 του ιατροτεχνολογικού προϊόντος HIPPOKRATIS Επιθέματα γάζας μη αποστειρωμένα 10X20 PLY, REF: 1020121301EOF GreeceArticle 141(1) procedure: Quarter-based selective dry cow therapyEOF GreeceΔιαδικασία βάσει του άρθρου 141(1): Επιλεκτική θεραπεία κατά την ξηρά περίοδο ανά τεταρτημόριο μαστικού αδέναEOF GreeceΓενόσημα Ιουλίου 2026 _ Προτεινόμενες Τιμές προς ΔιαβούλευσηEOF GreeceΣτοιχεία εκτέλεσης προϋπολογισμού ΕΟΦ μηνός Ιουλίου 2026EOF GreeceΗ PRAC ξεκινά την ανασκόπηση της ασφάλειας των ενέσιμων φαρμάκων που περιέχουν σίδηροEOF GreeceΤελικές Προτεινόμενες _ Νέα 2ου Τριμήνου 2026 _ Ανατιμολόγηση προϊόντων αναφοράς λόγω λήξης της προστασίας δεδομένων τους _ Μη Αποζημιούμενα: αναπροσαρμογή τιμήςEOF GreeceΓενόσημα Ιουνίου 2026_Τελικές Προτεινόμενες ΤιμέςEOF GreeceΑνάκληση των παρτίδων του συνημμένου πίνακα, του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class I, NDI Passive Sphere & κιτ βελόνων βιοψίας.EOF GreeceTONGKAT ALI HONEY HERBAL MIXED PASTE / (ΣΙΛΔΕΝΑΦΙΛΗ, ΤΑΔΑΛΑΦΙΛΗ)EOF GreeceΑΝΑΚΟΙΝΩΣΗ ΣΧΕΤΙΚΑ ΜΕ ΤΗ ΔΙΑΘΕΣΗ ΣΚΕΥΑΣΜΑΤΩΝ ΜΕΣΩ ΔΙΑΔΙΚΤΥΟΥEOF GreeceΑνάκληση όλων των παρτίδων του παρακάτω πίνακα, του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIb, Σωλήνες τραχειοστομίας Hi-Lo με αεροθάλαμο ShileyEOF GreeceΜΗΣΥΦΑ 2ου Τριμήνου 2026 _ Προτεινόμενες Τιμές προς ΔιαβούλευσηEOF GreeceΕπίσκεψη της Γ.Γ. 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VIOLAK INTERNATIONAL A.E.»EOF GreeceΑνάκληση των παρτίδων του παρακάτω πίνακα του Ιατροτεχνολογικού προϊόντος κατηγορίας MDD Class IIb, Smartbag-Liquid Acid ConcentratesEOF GreeceΣύσκεψη στον ΕΟΦ για την ομαλή λειτουργία της εφοδιαστικής αλυσίδας των φαρμάκων.EOF GreeceΦαρμακευτικά προϊόντα που περιέχουν δεσογεστρέλη και ετονογεστρέλη: Απευθείας επικοινωνία προς επαγγελματίες υγείαςEOF GreeceREGISTRATION PROCEDURE FOR VETERINARY MEDICINAL PRODUCTS WITH A CENTRALISED MARKETING AUTHORISATIONEOF GreeceΔΙΑΔΙΚΑΣΙΑ ΚΑΤΑΧΩΡΙΣΗΣ ΚΤΗΝΙΑΤΡΙΚΩΝ ΦΑΡΜΑΚΩΝ ΜΕ ΚΕΝΤΡΙΚΗ ΑΔΕΙΑ ΚΥΚΛΟΦΟΡΙΑΣEOF GreeceREGISTRATION AND VARIATION PROCEDURE FOR VETERINARY MEDICINAL PRODUCTS WITH A CENTRALISED MARKETING AUTHORISATION (MA)EOF GreeceΔΙΑΔΙΚΑΣΙΑ ΚΑΤΑΧΩΡΙΣΗΣ ΚΑΙ ΤΡΟΠΟΠΟΙΗΣΗΣ ΚΤΗΝΙΑΤΡΙΚΩΝ ΦΑΡΜΑΚΩΝ ΜΕ ΚΕΝΤΡΙΚΗ ΑΔΕΙΑ ΚΥΚΛΟΦΟΡΙΑΣ (Α.Κ.)EOF GreeceΑνάκληση της Άδειας Χονδρικής πώλησης φαρμάκων για Ανθρώπινη Χρήση στη φαρμακαποθήκη ΜΕΝΤΙΚΑΜΕΡΚ ΑΕEOF GreeceΣυμπερίληψη Ελλάδας στον κατάλογο χωρών αναφοράς του Αιγυπτιακού Οργανισμού Φαρμάκων.EOF GreeceΑπαγόρευση κυκλοφορίας του προϊόντος TEMPUFEN της εταιρείας ANTALIA PHARMA ΜΟΝΟΠΡΟΣΩΠΗ Ι.Κ.Ε.EOF GreeceΑνάκληση της παρτίδας 150426 του Καλλυντικού προϊόντος Lolota Professional nails UV& UV LED GEL POLISH 46EOF Greece식약처, 인도네시아와 할랄 인증 협력 강화...K-푸드·K-뷰티 수출지원MFDS Press Releases[보도참고] 네일폴리시 사용기한 표시에 대한 첫 논의 시작MFDS Press Releases[정부합동] 형사사법체계 개편에도 마약범죄 강력대응 위한 범정부 협력 강화MFDS Press Releases[보도참고] 아플라톡신 초과 검출된 '볶음땅콩' 회수 조치MFDS Press Releases[보도참고] 식약처, 소비자단체와 유전자변형식품 표시제도 소통MFDS Press Releases중국산 가짜 화장품, 건강기능식품 등 국내 유통 브로커 적발MFDS Press Releases[보도참고] 식약처-양구군, 국가생약자원센터 협력 기반 강화 위해 '맞손'MFDS Press Releases[보도참고] 건강기능식품은 붉은색 도안과 체크를 확인하세요!!MFDS Press Releases식약처가 제안한 ‘건조대파’ 농약 기준, 국제기준으로 채택MFDS Press Releases“가족 건강을 위한 추석 선물 고를 땐 반드시 확인하세요”MFDS Press Releases[보도참고] 식약처, ‘해썹(HACCP) AI 콘텐츠 공모전’ 수상작 선정MFDS Press Releases[부처합동] 정부, 임신중지 약물 정식 도입 추진MFDS Press Releases[보도참고] 식약처, 디지털의료기기 구성요소 성능평가 가이드라인 마련MFDS Press Releases[보도참고] 디지털의료기기 GMP 제도 알기 쉽게 알려드려요MFDS Press Releases[보도참고] ‘2026년 화장품 위해평가 국제심포지엄’ 개최MFDS Press Releases식약처, 제약바이오원팀 구성 K-의약품 태국 진출 견인차로 나서MFDS Press Releases식약처, 글로벌 화장품 규제기관장 협의체 의장국으로 선출MFDS Press Releases[보도참고] 식약처, 수의사 대상 의료용 마약류 안전사용 교육 강화MFDS Press Releases식약처, 알부민 식품 3차 점검서 부당광고 5개 업소 추가 적발MFDS Press Releases우즈베키스탄과 ‘의료제품 규제 협력 업무협약(MOU) 체결.. 중앙아시아 협력 기반 마련MFDS Press Releases식약처, 추석 맞아 자매도시 제천시에 ‘성과보상금’ 환원... 따뜻한 상생·나눔 실천MFDS Press Releases[보도참고] 안전한 어린이 의약정보 콘텐츠 공모전, ‘의약품안전나라’에서 지금 참여하세요MFDS Press Releases[보도참고] 긴급도입 의료기기 공급은 안정적으로, AI 허위광고 제재는 엄격하게MFDS Press Releases커피, 치킨 등 조리·판매 편의점 및 무인 판매점 집중점검 실시MFDS Press Releases식약처, 의료현장 필수의약품 공적 공급 확대로 환자 치료기회 보장 지원MFDS Press Releases식용색소를 사용한 중국산 줄기상추 국내에 수입되지 않은 것으로 확인MFDS Press Releases식약처, 시각·청각장애인 위한 ‘모두누리 식품표시’ 서비스 제공MFDS Press Releases[보도참고] 잔류농약 기준 초과 검출된 수입 '목이버섯' 및 '백목이버섯' 회수 조치MFDS Press Releases[보도참고] 식약처, 한약(생약)제제 제조업체 간담회 개최MFDS Press Releases[보도참고] 식약처, 디지털치료기기 임상시험계획서 작성 가이드라인 개정MFDS Press Releases[보도참고] 식약처, 다회용기 세척업체 대상 '안심세척업소' 시범인증 사업설명회 개최MFDS Press Releases식약처, 무글루텐 제품 온라인 부당광고 20건 적발MFDS Press Releases[보도참고] 식약처, 의약외품 손소독제 수거·검사 결과, 4개 제품 부적합MFDS Press Releases[보도참고] 식약처, 국내 개발 각결막 상피 장애 개선 신약 허가MFDS Press Releases[보도참고] 식약처, 산업체·민간 검사기관 대상, 동물용의약품 시험법 설명회(2차) 개최MFDS Press Releases국내 유통 중인 중국산 줄기상추 식용색소 긴급검사 결과 8건 모두 불검출MFDS Press Releases'확신의 K-뷰티, 꽃을 피우다', 2026년 화장품의 날 기념식 개최MFDS Press Releases식약처, 세계 최초 글로벌 화장품 규제기관장 협의체 신설MFDS Press Releases식약처, 공공기관 기능 개혁으로 국민 체감 식의약 안전수준 향상 추진MFDS Press Releases[보도참고] 식약처, 의약외품 수입 시 제출서류 합리화 및 품목별 시험·심사기준 명확화MFDS Press Releases[보도참고] 식약처, K-의료기기 기술 자립과 혁신의 시작을 위한 통합포럼 개최MFDS Press Releases[보도참고] 식약처, 페닐케톤뇨증 환자의 고페닐알라닌혈증 치료 희귀의약품 허가MFDS Press Releases바이오 대도약을 향한 ‘2026 GBC’ 성황리에 마무리MFDS Press Releases식약처, 의약품 규제기관 국제연합 집행위원회 선출 및 정상회의 개최MFDS Press Releases[보도참고] 식약처, 중국 식품 수출업체 대상 등록 방법 설명회 개최MFDS Press Releases[보도참고] 전자민원, 더 이상 헤매지 마세요… 식약처, 알기 쉬운 맞춤형 영상 배포MFDS Press Releases[보도참고] 잔류농약 기준 초과 검출된 수입 '목이버섯' 회수 조치MFDS Press Releases환자의 경험을 정책으로…식약처, 환자와 함께 식의약 안심정책을 설계한다MFDS Press Releases식약처, ‘세계보건기구 규제시스템 역량강화 및 훈련 분야 협력센터’ 세계 최초 지정MFDS Press Releases식약처, 흑염소 함량 거짓 표시·광고한 업체 등 15곳 적발MFDS Press Releases식약처, 내년도 식의약 안전관리 정부 예산안 6.1% 증가, 8,829억원 편성MFDS Press Releases[보도참고] 식약처, 성장호르몬제제 안전 사용 조치 강화MFDS Press Releases식약처, 식품영업자 행정절차 간소화...음식점 바가지요금 처분 강화MFDS Press Releases중국 포름알데히드 사용 배추 국내로 수출되지 않은 것으로 확인MFDS Press Releases[보도참고] 식약처, 희소의료기기 등 시판 후 조사 면제 기준 마련MFDS Press Releases[보도참고] 식약처, 안과용 의약품 개발·허가 '품질 길잡이' 마련MFDS Press Releases[보도참고] 식약처, 비침습 자동혈압계 임상정확도 평가 가이드라인 제정MFDS Press Releases[보도참고] 식약처, 9월 7일 ‘화장품의 날’ 기념 다양한 이벤트 실시MFDS Press ReleasesSodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP AmpulesFDA MedWatchNitric Oxide Delivery System Correction: NOxBOX Updates Use Instructions for NOxBOXi Nitric Oxide Delivery SystemFDA MedWatchAstraZeneca filed Form 6-KSEC EDGARBioNTech filed Form 6-KSEC EDGARNational Vaccine Injury Compensation Program; List of Petitions ReceivedFederal RegisterElectronic Submission Template for Medical Device Premarket Approval Applications (PMAs); Draft Guidance for Industry and Food and Drug Administration Staff; AvailabilityFederal RegisterAgency Forms Undergoing Paperwork Reduction Act ReviewFederal RegisterBiosimilar User Fee Act III Future Needs in the Development of Interchangeable Products Post-Workshop; Draft Strategy DocumentFederal RegisterNational Institute of Allergy and Infectious Diseases; Amended Notice of MeetingFederal RegisterProposed Collection; 60-Day Comment Request; Post-Award Reporting Requirements Including Research Performance Progress Report (OD)Federal RegisterProposed Collection; 60-Day Comment Request; PHS Applications and Pre-Award Reporting Requirements (OD)Federal RegisterNotice of Supplemental Funding, Delta Region Community Health Systems Development ProgramFederal RegisterHealthy Start Self-Measured Blood Pressure MonitoringFederal RegisterInfant-Toddler Court Program-National Resource CenterFederal RegisterTarget Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; AvailabilityFederal RegisterNational Library of Medicine; Notice of Partially Closed MeetingFederal RegisterCenter for Scientific Review; Amended Notice of MeetingFederal RegisterNational Center for Advancing Translational Sciences; Amended Notice of MeetingFederal RegisterNotice of Supplemental Funding, National Rural Health Policy, Community, and Collaboration ProgramFederal RegisterNotice of Supplemental Funding, National Rural Health Information Clearinghouse ProgramFederal RegisterNotice of Supplemental Funding; Rural Residency Planning and Development Technical Assistance ProgramFederal RegisterHow to Use Patient Feedback in Clinical Trial DesignCISCRP Patient InfoNovo Nordisk filed Form 6-KSEC EDGARSanofi filed Form 6-KSEC EDGARRecommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method; Guidance for Industry; AvailabilityFederal RegisterAgency Information Collection Activities: Proposed Collection; Comment RequestFederal RegisterMedical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification DevicesFederal RegisterMedicare and Medicaid Programs; Application From DNV Healthcare USA Inc. (DNV) for Continued CMS-Approval of its Hospital Accreditation ProgramFederal RegisterProposed Information Collection Activity; Diaper Distribution Demonstration and Research Pilot Beneficiary and Organizational Survey and Beneficiary ReportFederal RegisterDrug ShortagesFDA Drug Safety CommunicationsMedicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2027Federal RegisterMedicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Level II CodingFederal RegisterCenter for Scientific Review; Notice of Closed MeetingsFederal RegisterOpportunity To Co-Sponsor Events With the Office of Research IntegrityFederal RegisterGovernment-Owned Inventions; Availability for LicensingFederal RegisterCenter for Scientific Review; Amended Notice of MeetingFederal RegisterAgency Information Collection Request; 30-Day Public Comment RequestFederal RegisterOrder Under Sections 362 and 365 of the Public Health Service Act Continuing the Suspension of the Right To Introduce Certain Persons From Countries Where a Quarantinable Communicable Disease ExistsFederal RegisterAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in ManufacturingFederal RegisterProposed Collection; 60-Day Comment Request; NIH Intramural Reporting of Research Misconduct (IRRM) Web Form (Office of the Director/Office of Intramural Research)Federal RegisterMicrobiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pathogen-Agnostic SequencingFederal RegisterDrug label update: unspecified productopenFDA Drug LabelsDrug Safety CommunicationsFDA Drug Safety CommunicationsCo-Creating an Individual Data Return Template: A Patient-Centered Approach by CISCRP and BiogenCISCRP Patient InfoDompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-DisclosureHyman, Phelps & McNamara (FDA Law)Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery DeviceFDA MedWatchAstraZeneca filed Form 6-KSEC EDGARNovo Nordisk filed Form 6-KSEC EDGARGSK filed Form 6-KSEC EDGARWorld Trade Center Health Program; Petition 048a-Peripheral Artery Disease; Finding of Insufficient EvidenceFederal RegisterWorld Trade Center Health Program; Petitions 048 and 051a-Stroke; Finding of Insufficient EvidenceFederal RegisterProspective Grant of an Exclusive Patent License: Development and Commercialization of Engineered Cell Therapies for the Treatment of HPV 16 E6-Expressing CancersFederal RegisterCenter for Scientific Review; Notice of Closed MeetingsFederal RegisterCenter for Scientific Review; Amended Notice of MeetingFederal RegisterProposed Information Collection Activity; Multistate Financial Institution Data Match With Federally Assisted State Transmitted LevyFederal RegisterNational Cancer Institute; Notice of Closed MeetingFederal RegisterStatistical Considerations for the Design of Rare Disease Clinical Investigations; Establishment of a Public Docket; Request for Information and CommentsFederal RegisterConfirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory EvidenceHyman, Phelps & McNamara (FDA Law)AstraZeneca filed Form 6-KSEC EDGARBioNTech filed Form 6-KSEC EDGAR[SHINSA]SaMD page updated (guide revised, seminar videos and materials published, consultation schedule updated)PMDA Japan[SHINSA]CDx approved for identifying eligible patients (Updated)PMDA Japan[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updatedPMDA Japan[SHINSA]English Translation of Review Report: Opsumit (Partial Change Approval)PMDA Japan[SHINSA]List of Approved Medical Devices: April 2004 to December 2025PMDA Japan[SHINSA]English Translation of Review Report: remedē SystemPMDA Japan[IBENTO][IBENTO]Report on the PMDA Hokuriku Branch 10th Anniversary SymposiumPMDA Japan[YAKKYOKUKATA]JP Drafts (September 2026) Part 1 postedPMDA Japan[YAKKYOKUKATA]JP Drafts (September 2026) Part 2 postedPMDA Japan[SHINSA]English Translation of Review Report: Akuugo (Partial Change Approval)PMDA Japan[SHINSA]Points to Consider for the Evaluation of the Effects of Food on the Pharmacokinetics of Oral Drug Products (Early Consideration) posted.PMDA Japan[KOKUSAI]PMDA-ATC Training Materials have been updatedPMDA Japan[IBENTO][IBENTO]Report of PMDA-ATC & U.S. FDA Pediatric Review Seminar 2026PMDA Japan[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.430 postedPMDA Japan[ANZEN]Revisions of PRECAUTIONS: Tucatinib ethanolate, etc. postedPMDA Japan[ANZEN]PMDA Risk Communications: Azathioprine etc. postedPMDA Japan[SHINSA]One-Stop Service Platform by ENSEMBLExJ page updatedPMDA Japan[SHINSA]List of Approved Regenerative Medical Products: April 2015 to May 2026PMDA Japan[SHINSA]Information on biosimilars is updatedPMDA Japan[IBENTO][IBENTO]ASEAN-Japan Medical Devices Regulatory Symposium 2026 ReportPMDA Japan[IBENTO][IBENTO]ASEAN-Japan Medical Devices Regulatory Seminar 2026PMDA Japan[KOKUSAI]The 8th Asian Network Meeting (ANM) summary has been postedPMDA Japan[IBENTO][IBENTO]PMDA-ATC Blood Products Seminar 2026 for PPWG Applications open.PMDA Japan[IBENTO][IBENTO]PMDA-ATC Herbal Medicine Seminar 2026PMDA Japan[YAKKYOKUKATA]Press Release regarding international activities related to Pharmacopoeia postedPMDA Japan[KOKUSAI]PMDA Updates (2026 No.2) postedPMDA JapanReviews and Related ServicesPharmaceuticals and Medical Devices Agency (PMDA)[PMDA]PMDA Concludes a Memorandum of Understanding with the London School of Hygiene & Tropical Medicine (LSHTM) (News Release) (July 6, 2026) [222KB]PMDA Japan[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[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[SHINSA]List of Approved Drugs: April 2004 to February 2026PMDA JapanANMAT emitió Carta de Cierre por la subsanación de los incumplimientos detectados en CSL Behring S.A.ANMAT NoticiasANMAT fortaleció la cooperación regulatoria regional en la Reunión Anual Latinoamericana de DIA 2026 en la Ciudad de MéxicoANMAT NoticiasANMAT levantó la inhibición de importación dispuesta a la firma GLAM DISTRIBUCIONES S.R.L.ANMAT NoticiasANMAT inhibió las actividades productivas de la firma RIPEZZI S.R.L. y prohibió el uso de todos los productos médicos importados por la mismaANMAT NoticiasANMAT emitió una Carta de Advertencia a CSL Behring S.A. por incumplimientos a las Buenas Prácticas de FabricaciónANMAT NoticiasANMAT evaluó y liberó más de 430 lotes de vacunas entre junio de 2025 y mayo de 2026ANMAT NoticiasANMAT actualiza los criterios regulatorios para software como dispositivo médico (SaMD)ANMAT NoticiasNueva convocatoria para realizar prácticas preprofesionalesANMAT NoticiasANMAT dispuso la baja de habilitación de la firma REHUE S.A. y prohibió sus productos importadosANMAT NoticiasNuevos proyectos de consulta para la opinión públicaANMAT NoticiasANMAT emitió una Carta de Advertencia a UGAL FARMACÉUTICA S.A. por incumplimientos a las Buenas Prácticas de FabricaciónANMAT NoticiasANMAT presentó la experiencia argentina en vigilancia y control post comercialización de dispositivos médicosANMAT NoticiasANMAT dispuso la baja de habilitación de dos establecimientos de TucumánANMAT NoticiasANMAT dispuso la baja de habilitación de la firma ALDERETE María DeidamiaANMAT NoticiasANMAT prohibió la comercialización y distribución de productos médicos de la firma Caggicamps S.R.L.ANMAT NoticiasDeshabilitación temporal del Sistema de Pago electrónicoANMAT NoticiasANMAT adecua el esquema de aranceles y trámites para Especialidades Medicinales y Productos MédicosANMAT NoticiasANMAT establece una nueva Sustancia de Referencia Farmacopea ArgentinaANMAT NoticiasANMAT dispuso la baja de habilitación de la firma Panalab S.A. ArgentinaANMAT NoticiasConcurso público y abierto para ocupar el cargo de Jefatura de Residentes de la Residencia en Control de Calidad de MedicamentosANMAT NoticiasIncorporación al MERCOSUR del reglamento para empresas de desinfestación y desinfecciónANMAT NoticiasANMAT actualiza los criterios para la elaboración de Soluciones Parenterales de Gran VolumenANMAT NoticiasNuevo egreso de residentes de ANMATANMAT NoticiasANMAT suspendió preventivamente la habilitación de Droguería Lomas S.A.ANMAT NoticiasNuevo formulario para notificar eventos adversos y desvíos de calidad de productos médicosANMAT NoticiasCambios en las competencias de control y fiscalización de alimentosANMAT NoticiasIncorporación al MERCOSUR de la nueva definición de contaminante en alimentosANMAT NoticiasActualización del Código Alimentario Argentino sobre materiales celulósicos en contacto con alimentosANMAT NoticiasActualización del Código Alimentario Argentino sobre disposiciones para envases, revestimientos, utensilios, tapas y equipamientos metálicos en contacto con alimentosANMAT NoticiasInformación sobre la modificación de Prospectos de IFAs con cambio de condición a Venta LibreANMAT NoticiasANMAT establece la condición de venta libre para diez ingredientes farmacéuticos activosANMAT NoticiasANMAT dispuso la baja de habilitación de la firma CASA OTTO HESS S.A.ANMAT NoticiasTitulares de Establecimientos y Directores Técnicos deberán acreditar la inexistencia de antecedentes penales para su habilitación y designaciónANMAT NoticiasANMAT dispone la baja de certificados de establecimientos y cancela registros de productos médicos de distintas firmasANMAT NoticiasANMAT canceló la habilitación para tránsito interjurisdiccional de la firma JMG S.A.ANMAT NoticiasANMAT simplifica el marco regulatorio para las modificaciones posteriores al registro de especialidades medicinales de origen biológicoANMAT NoticiasIncorporación al MERCOSUR del nuevo Reglamento Técnico para la leche UAT (Ultra Alta Temperatura - UHT)ANMAT NoticiasANMAT levantó la inhibición de actividades productivas y la inmovilización preventiva de lotes de la firma DRAWER S.A.ANMAT NoticiasNueva convocatoria de la Revista Científica ANMATANMAT NoticiasANMAT actualiza el listado de sustancias sujetas a fiscalización especialANMAT NoticiasANMAT recibió a las Autoridades Regulatorias Nacionales de Referencia de las AméricasANMAT NoticiasIncorporación al Mercosur sobre productos de limpieza y afinesANMAT NoticiasANMAT inhibió las actividades productivas de la firma DIATER S.R.L.ANMAT NoticiasLa AEMPS informa de un error en el etiquetado de las prótesis vasculares Silver Graft y Silver Graft HelixAEMPS (Spain)La AEMPS informa de la actualización de la información de seguridad de los medicamentos veterinarios que contienen fenobarbitalAEMPS (Spain)La AEMPS recuerda cómo evitar errores de medicación por sobredosificación con vitamina DAEMPS (Spain)Reunión del Comité de Medicamentos de Uso Humano de septiembre de 2026AEMPS (Spain)La AEMPS habilita una nueva aplicación para presentar telemáticamente la declaración responsable de actividades de fabricación y/o importación de productos de cuidado personalAEMPS (Spain)La AEMPS informa de un fallo en determinados respiradores Newport HT70 Plus y piezas de recambio PCBAAEMPS (Spain)Boletín sobre Seguridad de Medicamentos de Uso Humano. 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Mojisola Christianah Adeyeye at the 49th Annual International Conference of the Chemical Society of NigeriaNAFDAC NigeriaInauguration Ceremony of the NAFDAC Pharmacist Reserve GroupNAFDAC NigeriaNAFDAC and NHREC Announce New Dates for Mandatory Stakeholders Training on Clinical Trial Regulations in NigeriaNAFDAC NigeriaPublic Notice on Blacklisting Ayrtons Saunders Ltd, UkNAFDAC NigeriaPublic Alert No. 043/2026-NAFDAC Places Products Marketed by Mofus Nigeria Ltd on Watchlist Pending Regulatory InvestigationNAFDAC NigeriaPublic Alert No. 042/2026-Alert on the Seizure of Suspected Substandard and Falsified BPPL Artemether/Lumefantrine 80mg/480mgNAFDAC NigeriaPublic Alert No. 041/2026 – Alert on Suspected Counterfeit ORACIRE+ ToothpasteNAFDAC NigeriaPublic Alert No: 039/2026 – Alert on the Risk of Drug Poisoning Associated with Concurrent Use of Gabapentinoids and Other MedicinesNAFDAC NigeriaPublic Alert No. 038/2026 – Alert on Adulterated and Substandard Medicines- NITRAS, KADIN 2, ACEFYL and LORATADINE 24 Recalled by the Drug Regulatory Authority of Pakistan (DRAP)NAFDAC NigeriaRegulatory Clarification on Deleject Disposable Needle Public AlertNAFDAC NigeriaRegulatory Clarification on Deleject Disposable Needle Public Alert No. 042/2026NAFDAC Nigeria2026 World Breastfeeding Week Capacity Building Event for Healthcare ProfessionalsNAFDAC NigeriaPublic Alert No. 042/2026- Alert on the Presence of Whitish Particulate Matter in Deleject Disposable Needles Batch No. 240605NAFDAC NigeriaNAFDAC joins the Federal Ministry of Health and Social Welfare, nutrition partners, and the global community in celebrating World Breastfeeding Week 2026NAFDAC NigeriaHandling Manufacturer Investigation Reports for Medical Devices and IVDsNAFDAC NigeriaNAFDAC Continued Enforcement of the Ban on Sub-200ml Sachet & PET Bottle Alcoholic Products: Update on Nationwide Mop-Up Operation.NAFDAC NigeriaBlacklisting of Onifam Laboratories LtdNAFDAC NigeriaPublic Alert No. 037/2026 – Alert on Suspected Counterfeit Pulmicort® (Budesonide) Inhalation SuspensionNAFDAC NigeriaPublic Alert No. 036/2026 – Alert on Suspected Counterfeit Products Mimicking Forxiga® (Dapagliflozin)NAFDAC NigeriaPublic Alert No. 035/2026 – Alert on the Marketing and Sale of Unregistered Menofix CompositionNAFDAC NigeriaPublic Alert No. 034/2026 – Niger Republic Imposes Import Ban on Bulmex Parboiled Rice from India due to Metallic ContaminationNAFDAC NigeriaEnd-Of-Pilot Validation, Learning And Dissemination Event of The 2026 Annual Market-Level Large Scale Food Fortification (LSFF) Maiden Digital Monitoring And Compliance SurveyNAFDAC NigeriaPropriedade intelectual e eficiência regulatória como motores do bem-estar regionalFIFARMA NewsIntellectual property and regulatory efficiency as drivers of regional well-beingFIFARMA NewsPropiedad intelectual y eficiencia regulatoria como motores del bienestar regionalFIFARMA NewsFIFARMA W.A.I.T. Indicator 2026: do tempo de espera à oportunidade de avançarFIFARMA NewsFIFARMA W.A.I.T. Indicator 2026: from waiting time to an opportunity to move forwardFIFARMA NewsFIFARMA W.A.I.T. Indicator 2026: del tiempo de espera a la oportunidad de avanzarFIFARMA NewsFIFARMA se une à Aliança para a Eliminação do HIV nas AméricasFIFARMA NewsFIFARMA Joins the Alliance for the Elimination of HIV in the AmericasFIFARMA NewsFIFARMA se suma a la Alianza para la Eliminación del VIH en las AméricasFIFARMA NewsNouveau guide destiné aux promoteurs pour la procédure synchronisée des études combinées CTR–MDR/IVDRFAMHP BelgiumGuide destiné aux promoteurs pour la procédure synchronisée des études combinées CTR–MDR/IVDRFAMHP BelgiumEnregistrement des antibiotiques dans VAMREG : e-learning pour les vétérinairesFAMHP Belgium50 ans de pharmacovigilance en Belgique : Save the DateFAMHP BelgiumDépassements de quotas : l’AFMPS poursuit ses travaux et renforce la transparenceFAMHP BelgiumÀ partir du 1e septembre 2026 : nouvelle version du formulaire de demande d'autorisation de mise sur le marché pour les procédures nationales, de reconnaissance mutuelle et décentraliséesFAMHP BelgiumActualisering van de lijst van essentiële stoffen voor voedselproducerende paardenFAMHP BelgiumModel van diergeneeskundig voorschrift: nieuwe verplichte vermeldingenFAMHP BelgiumPRAC juli 2026: nieuwe veiligheidsaanbevelingen voor anticonceptiemiddelen met desogestrel en etonogestrel en voor LitfuloFAMHP BelgiumFlash VIG-news: benzodiazepines en aanverwante geneesmiddelen: herhaling van de aanbevelingen voor een rationeel gebruikFAMHP BelgiumBenzodiazepines en aanverwante geneesmiddelen: herhaling van de aanbevelingen voor een rationeel gebruikFAMHP BelgiumUpdate of document on approval dates for variations, renewals and notifications for medicinal products for human useFAMHP (Belgium)Update van het document over goedkeuringsdatum van variaties, hernieuwingen en notificaties bij geneesmiddelen voor menselijk gebruikFAMHP BelgiumLa 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 BelgiumDatrowayFAMHP BelgiumIMDYLLTRAFAMHP BelgiumSigniforFAMHP BelgiumBeperkte beschikbaarheid van Azactam 1 g en 2 g poeder voor oplossing voor injectie/infusie: aanbevelingen voor artsen-specialisten en ziekenhuisapothekersFAMHP BelgiumToekomstige Europese wetgevingen: stand van zakenFAMHP BelgiumVAMREG disponible à partir du 1 juillet 2026 : début de l’enregistrement obligatoire des antibiotiques à usage vétérinaireFAMHP BelgiumLa nouvelle application web BioVigilance est disponible !FAMHP BelgiumPRAC juni 2026: herziening afgerond van veiligheidssignaal over valproaat en verwante stoffen en aanbeveling voor gezondheidszorgbeoefenaars met nieuwe veiligheidsgegevens over chikungunya-vaccin IxchiqFAMHP BelgiumMexiletine PRFAMHP BelgiumDisponibilité 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 BelgiumZepzelcaFAMHP BelgiumAtrasentanFAMHP BelgiumTransition of the Icelandic Medicines Agency’s Website in Full SwingIMA IcelandAre you working with the non-clinical package for clinical trial applications? See Q&A-update!Danish Medicines AgencyJoin the Danish Medicines Agency’s ATMP Open HouseDanish Medicines AgencyRegister-based study suggests a slightly increased risk of meningiomas in women using hormonal contraception containing a progestogenDanish Medicines AgencyAre you running clinical trials? You can now activate e-mail notifications in CTISDanish Medicines AgencyAre you working with cell therapy and planning a clinical trial?Danish Medicines AgencyFórum Estadão discute os principais desafios e avanços da oncologia no País; Interfarma participaInterfarma BrazilInterfarma participa de debates sobre futuro da saúde e doenças raras em BrasíliaInterfarma BrazilInterfarma na imprensa: Saúde Insider publica entrevista exclusiva com Renato PortoInterfarma BrazilInterfarma apresenta Carta aos Presidenciáveis com 10 prioridades para a saúde no próximo governoInterfarma BrazilInterfarma na imprensa: Jornal Hoje destaca atraso no acesso a medicamentos já incorporados ao SUSInterfarma BrazilFraudes, desperdícios e sobreutilização impactam mais a sustentabilidade dos planos de saúde do que medicamentos, aponta estudo da InterfarmaInterfarma BrazilBaixe o estudo Saúde Suplementar em Transição: Acesso à Inovação e Valor AssistencialInterfarma BrazilInterfarma integra o CNCP e amplia contribuição ao combate à pirataria e defesa da inovaçãoInterfarma BrazilInterfarma integra Coalizão Empresarial contra a DesinformaçãoInterfarma BrazilMarco Legal impulsiona pesquisa clínica e traz benefícios econômicos e acesso mais rápido à inovaçãoInterfarma BrazilMedicamentos oncológicos considerados essenciais pela OMS ainda não chegam aos pacientes do SUS, aponta levantamento da InterfarmaInterfarma BrazilArtigo: O verdadeiro valor da inovação está na jornada do pacienteInterfarma BrazilInterfarma na imprensa: estudo da Interfarma sobre judicialização da saúde é destaque na mídiaInterfarma BrazilInterfarma na imprensa: Jornal da Record destaca potencial do Brasil para liderar pesquisa clínicaInterfarma BrazilEm nota, entidades do setor farmacêutico alertam para riscos de produtos sem registro no BrasilInterfarma BrazilInterfarma na imprensa: Estudo da Interfarma sobre judicialização é destaque na Folha de S.PauloInterfarma BrazilInterfarma apresenta estudo sobre avanços da pesquisa clinica no Brasil: país ganha posições importantesInterfarma BrazilM/s. Reine Lifescience – Pregabalin BP/EP and 5 itemsCDSCO IndiaM/s Olon Active Pharmaceutical Ingredients India Private Limited, – Rifampicin Ph.Eur/ BP and 13 itemsCDSCO IndiaM/s. Valencia Life Sciences – Lidocaine BP/EP/USP and Lidocaine Hydrochloride BP/EP/USPCDSCO IndiaM/s. Amoli Organics – Solifenacin Succinate IH and 29 itemsCDSCO IndiaM/s. Hetero Drugs Limited (Unit-IX) – Gabapentin USP/Ph.Eur. and 42 itemsCDSCO IndiaM/s. Herbert Brown Pharma. & Research Lab. – Methyl Nicotinate Ph. Eur/BP and Benzyl Nicotinate DAÐCDSCO IndiaM/s. MSN Organics Private Limited – Asenapine Maleate IÐ and 20 itemsCDSCO IndiaClarification on the submission of applications for grant of Permission to Import and Market New Drugs not approved anywhere in the world, wherein phase III Global Clinical Trials (GCT) are ongoing or completed with participation of Indian subjects under the New Drugs and Clinical Trials Rules, 2019CDSCO IndiaM/s. Suleshvari Pharma Pvt Ltd – Famotidine BP and 13 itemsCDSCO IndiaM/s. SUNMOON PHARMACEUTICALS PVT. LTD. – Isoxsuprine Hydrochloride USP and 3 itemsCDSCO IndiaM/s. Dr. Reddy's Laboratories Limited. – Abemaciclib IH and 37 itemsCDSCO IndiaM/s. Lokhith Healthcare Pvt. Ltd. – Guaifenesin USPCDSCO IndiaM/s. Nuray Chemicals Private Limited, – Ketoconazole Ph.Eur. and 58 itemsCDSCO IndiaM/s. Anuh Pharma Limited (Public Limited), – Gliclazide Ph.Eur and 14 itemsCDSCO IndiaM/s. Unimax Chemicals Pvt. Ltd. (Private Limited) – Erythromycin Base BP/USP/EP and 2 itemsCDSCO IndiaVigilance on imported cosmetics products sold in the domestic market without valid lmport Registration certificateCDSCO IndiaClarification regarding submission of applications under Rule 4 of the Drugs and Cosmetics (Compounding of Offences) Rules, 2025.CDSCO IndiaM/s. Endoc Biotech Private Limited – Mupirocin IP/BP/EP/USPCDSCO IndiaM/s. Honour Lab Limited, – Tedizolid Phosphate IHCDSCO IndiaM/s. Nira Life Sciences Pvt. Ltd. – Clonixin Lysinate IÐ and 4 itemsCDSCO IndiaM/s. Shodhana Laboratories Private Limited, – Etofenamate Ph.Eur. and 16 itemsCDSCO IndiaM/s. Ravi Biolife Private Limited, – Methotrexate Disodium IH and 8 itemsCDSCO IndiaM/s. Lewens Labs Pvt. Ltd. – Levodropropizine EP and 3 itemsCDSCO IndiaGuidance document on Medical Device Software under MDR-2017CDSCO IndiaM/s. Kadamb Pharmachem, – Valproic Acid BP/IP and 2 itemsCDSCO IndiaM/s. Titan Pharmaplus Pvt Ltd. – Carbocisteine Ph. Eur. and Eltrombopag Olamine IHCDSCO IndiaM/s. Hetero Labs Limited, Unit-IX – Abacavir Sulphate USP and 12 itemsCDSCO IndiaM/s. Atul Bioscience Ltd. – Fluconazole BP/ÐÐ and 14 itemsCDSCO IndiaM/s. Elixir Pharma Chem Private Limited, – Glibenclamide BP and 2 itemsCDSCO IndiaM/s. Megafine Pharma (P) Ltd. – Donepezil Hydrochloride Monohydrate Ph. Eur. and 4 itemsCDSCO IndiaM/s. Kevy's Generics Private Limited – Escitalopram Oxalate IP/EP/USP and Carvedilol IP/EP/USPCDSCO IndiaM/s. Haleos Labs Limited – Cimetidine USP and 11 itemsCDSCO IndiaM/s. Lifecare Laboratories Private Limited – Biperiden Hydrochloride Ph.EurCDSCO IndiaM/s. Andhra Organics Limited – Sulfadiazine BP/ Ph.Eur /USP and 3 itemsCDSCO IndiaInviting comments on consideration of the proposal regarding Issue of use of brand name extensions by the pharmaceutical firmsCDSCO IndiaM/s Zentiva Private Limited – Trimecaine Hydrochloride IH and 9 itemsCDSCO IndiaM/s. Neuland Laboratories Ltd, Unit-I, – Rotigotine Ph.Eur and 27 itemsCDSCO IndiaM/s. Melody Healthcare Pvt. Ltd. – Perindopril Arginine IH and 20 itemsCDSCO IndiaM/s. Optimus Drugs Private Limited. – Apixaban IHS and 19 itemsCDSCO IndiaM/s. Bal Pharma Ltd, – Ebastine BP/EP and Gliclazide BP/EPCDSCO IndiaList of new drugs approved in the year 2001CDSCO Indiam/s. Alivus Life Sciences Limited – Olopatadine Hydrochloride USP and 56 itemsCDSCO IndiaM/s. Valens Molecules Private Limited – Sulfamethizole BP/Ph.Eur. and Sulfasalazine BP/USP/Ph.EurCDSCO IndiaSale of In-Vitro Fertilization media, reagents and related consumables used in Assisted Reproductive Technology proceduresCDSCO IndiaRegulation of Formulation intermediates such as Directly Compressible granules, Taste masked granules, Modified release granules / PelletsCDSCO IndiaSale of In-Vitro Fertilization media, reagents and related consumables used in Assisted Reproductive Technology proceduresCDSCO IndiaSubmission of Post Approval Changes Applications of Registration Certificate and Import Licence of Human Vaccines and Anti-sera through SUGAM PortalCDSCO IndiaM/s.Neuland Laboratories Ltd – Bempedoic acid IH and 3 itemsCDSCO IndiaM/s Shakti Lifescience Private Limited, – Abiraterone Acetate USP and 8 itemsCDSCO IndiaM/s Alembic Pharmaceuticals Limited – Pinaverium Bromide IH and 52 itemsCDSCO IndiaM/s Themis Medicare (l) Ltd – Ketamine Hydrochloride IP/BP/USPCDSCO IndiaM/s Cohance Lifesciences Limited, – Levomepromazine Maleate EP/BPCDSCO IndiaM/s. Vasudha Pharma Chem Limited, – Aripiprazole Ph.Eur and 23 itemsCDSCO IndiaConstitution of Consultancy Committee of Key Stakeholders for Advice on Suo-Motu Disclosure under Section 4 of the RTI Act, 2005 in CDSCOCDSCO IndiaSubmission of Compliance for lmported/manufactured Hair Color Cosmetics Products as per Cosmetics Rules, 2020 and applicable BIS StandardsCDSCO IndiaM/s. Srikem Laboratories Pvt. Ltd. – Cyclizine ÐÐ and 11 itemsCDSCO IndiaBrief note on Two Days workshop on Medical Devices Frameworks organized by Danish Medical Agency (DKMA)- CDSCO on 8-9 April 2026CDSCO IndiaM/s. Sohan Healthcare Pvt. Ltd – Gliclazide BP/IP/JP/Ph.Eur and 3 itemsCDSCO IndiaTransfer List 2025CDSCO IndiaImplementation of Pharmacovigilance (PV) System as per the requirement of Schedule M of Drugs & Cosmetics Act 1940 and the Rules made there underCDSCO IndiaCONFERENCE DE PRESSE : Présentation de la plateforme présidentielle du LeemLEEM FranceMichel Bellandi est élu au Conseil d’administration du LeemLEEM FranceRépublique démocratique du Congo : 8 tonnes de médicaments acheminées en Ituri pour soutenir la réponse à l'épidémie d'EbolaLEEM FranceQu’attendent les Français de leur système de santé ? La concertation nationale pour l’avenir du médicament livre ses premières conclusionsLEEM FranceHidden costs in Environmental Monitoring: Why Quality is more expensive than you think?A3P FranceOvercoming the Financing Barrier to the Environmental Transition in Pharmaceutical ManufacturingA3P FranceDépasser la barrière du financement de la transition environnementale de la production pharmaA3P FranceWays to Optimize Manual Visual Inspections Beyond Regulatory RequirementsA3P FranceFactoring Sustainability Procurement decisions: Environmental AspectsA3P FranceUse of a Justified Sample Size and Criteria for the Validation of Visual Inspection ProcessesA3P FranceMajor Discrepancies in Visual Inspections: Lessons from the ANSM Inspections, 2023–2025A3P FranceBiopharma Industry Readiness for AI Implementation. Key Questions & Answers.A3P FranceArtificial Intelligence in GMP Environments: Where Do We Stand?A3P FranceDigitalisation: Considerations for Data Integrity & Data ReviewA3P FranceLe Leem finalise sa gouvernance et se mobilise pour les grandes échéances politiques de santé à venirLEEM France16 tonnes de produits de santé acheminées vers Kharkiv et plusieurs autres villes ukrainiennes.LEEM FranceL’industrie pharmaceutique poursuit son engagement en faveur de l’insertion et de l’emploi des personnes en situation de handicapLEEM FranceTulipe en 2025 : +16 % de produits de santé expédiés pour renforcer l’accès aux soinsLEEM FrancePlus de 109 tonnes de produits de santé mobilisées depuis le début de l’année 2026LEEM FranceBaromètre 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 FrancePolityka lekowa powinna optymalizować efekt zdrowotny, nie tylko budżetINFARMA PolandDobre prawo wymaga dialogu, nie etykietINFARMA PolandZmiany tak, ale w dialogu i likwidujące barieryINFARMA PolandStanowisko do projektu ustawy o zmianie ustawy o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych oraz niektórych innych ustawINFARMA PolandKażde 1 euro zainwestowane w nowe leki przynosi Europie 5,67 euro zwrotu.INFARMA PolandSwissmedic hospital inspections 2025: supervision having an effect, but action still neededSwissmedic Official NewsCross-agency targeted campaign “Peptides 2026”Swissmedic Official NewsThe Estonian medicinal products market in the second quarter 2026SAM EstoniaNew Medical Devices and Appliances Database (EMDDB) launches next weekSAM Estonia25 ก.ค. 69อย. กำชับผู้ประกอบการใช้วัตถุเจือปนอาหารที่มีไนไตรท์ให้ถูกต้อง ตรวจเข้มสถานที่ผลิตอาหารกลุ่มเสี่ยง พร้อมเผยแพร่สื่อแนะนำการใช้อ่านเพิ่มเติม →Thai FDA24 ก.ค. 69อย. แท็กทีม 11 องค์กร คิกออฟ ยกระดับอาหารอนาคตไทย ผ่านระบบบัญชี Positive list หนุน SMEs แข่งขันระดับสากลอ่านเพิ่มเติม →Thai FDA24 ก.ค. 69อย. เดินหน้าขับเคลื่อน “ทางเลือกสุขภาพ” ติวเข้มผู้ประกอบการทั่วประเทศ มุ่งเพิ่มผลิตภัณฑ์สุขภาพ สร้างทางเลือกที่ดี ลดเสี่ยง NCDs อย่างยั่งยืนอ่านเพิ่มเติม →Thai FDA17 ก.ค. 69อย. เติมความรู้ ชูอาหารปลอดภัย ลงพื้นที่ ตลาดสด อตก. แนะวิธีเช็ก สารฟอกขาว - สารกันรา ยกระดับตลาดสดปลอดภัยใจกลางเมืองกรุงอ่านเพิ่มเติม →Thai FDA15 ก.ค. 69ข่าวประกาศผลการตรวจพิสูจน์อาหาร อย. แจ้งเตือนประชาชน หยุดบริโภคผลิตภัณฑ์อาหาร 25 รายการ หลังตรวจพบเป็นอาหารปลอมอ่านเพิ่มเติม →Thai FDA15 ก.ค. 69อย. เตือน ผลิตภัณฑ์เสริมอาหาร “วิสโตริน” อ้างรักษาโรคทางตาอ่านเพิ่มเติม →Thai FDA14 ก.ค. 69อย. ยืนยันผลตรวจพิสูจน์สายพันธุ์ปลา จากผู้เชี่ยวชาญด้านสายพันธุ์ปลา กรมประมงอ่านเพิ่มเติม →Thai FDA14 ก.ค. 69อย. รับการตรวจประเมิน PIC/S ตอกย้ำมาตรฐาน GMP ไทย สร้างความเชื่อมั่นคุณภาพยาอ่านเพิ่มเติม →Thai FDA14 ก.ค. 69“รัฐมนตรีฯ พัฒนา” นำทีมเผาทำลาย “ยาเสพติดของกลาง” รวม 17 ตัน ตอกย้ำความเชื่อมั่นไม่ย้อนกลับมาทำลายสังคมได้อีกอ่านเพิ่มเติม →Thai FDA14 ก.ค. 69อย. ตรวจสอบแล้ว ยาหยอดตาที่สหรัฐฯ เรียกคืน ไม่มีจำหน่ายในไทยอ่านเพิ่มเติม →Thai FDA07 ก.ค. 69อย. - ศุลกากร ร่วมปั้นนักธุรกิจสุขภาพ ขับเคลื่อนเศรษฐกิจไทย ก้าวล้ำสู่มาตรฐานสากลอ่านเพิ่มเติม →Thai FDA07 ก.ค. 69อย. เดินหน้ากวาดล้างผลิตภัณฑ์สุขภาพผิดกฎหมาย ผนึก บช.น. ทลายโรงงานผลิตและโกดังเก็บอาหารเสริมลดน้ำหนัก "บาชิ"อ่านเพิ่มเติม →Thai FDA15 July 2026Traditional herbal remedies - quality and safety mattersProduct typeTraditional medicinesConsumer Safety ArticlesHSA (Singapore)10 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)14 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)17 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)15 July 2026How health supplements are regulated by HSAProduct typeHealth supplementsConsumer Safety ArticlesHSA (Singapore)15 July 2026Getting savvy with health supplementsProduct typeHealth supplementsConsumer Safety ArticlesHSA (Singapore)23 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)1 July 2026Stakeholder Consultation on the Proposed Regulation for Complementary Health Products under the Health Products ActAudiencesConsumerHealthcare professionalIndustry memberProduct typeHealth supplementsHomeopathic medicinesTraditional medicinesPublic ConsultationsHSA (Singapore)30 June 2026Regulatory Update for Therapeutic Product Registration (30 June 2026)AudiencesIndustry memberProduct typeTherapeutic ProductsExtension of e-labelling to P and GSL medicinesRegulatory UpdatesHSA (Singapore)15 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)29 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)11 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)16 June 2026Healthpoints and Yuu PointsA concise summary of the main points regarding this article.Feature ArticlesHSA (Singapore)24 July 2026 News ReleaseWHO joins Uganda to celebrate 90 years of the Uganda Virus Research InstituteWHO AFROEmergency21 July 2026 Feature StoryUganda safeguards essential health services during Ebola outbreak responseWHO AFRO22 July 2026 News ReleaseMozambique launches Action Plan for Child Survival and reaffirms its commitment to reduce child mortalityWHO AFROBarefoot doctors bring health care closer to communities in EritreaWHO AFROUganda begins countdown to end of Ebola outbreakWHO AFROSinaspril Stroop alleen geschikt vanaf 5 jaarHet paracetamol drankje Sinaspril Stroop bevat de hulpstoffen propyleenglycol en alcohol. 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