Regulatory Agencies feed

Field Safety Notices: 1 May 2026

Decision: Medical devices given exceptional use authorisations

[KOKUSAI]PMDA-ATC Learning videos have been updated

Field Safety Notices: 20 to 24 April 2026

Decision: Orphan registered medicinal products

Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse

“DIAFORM RX”

Guidance: The Innovative Devices Access Pathway (IDAP)

Public Alert No. 024/2026 – Alert on Counterfeit Augmentin 625mg Tablets (Batch No. AC3N) in Nigeria

Sixth resumed meeting of the open-ended Intergovernmental Working Group (IGWG 6) on the WHO Pandemic Agreement: PABS instrument

Note to Industry on Requirement for Bioequivalence Study

Interfarma na Imprensa: Interfarma ressalta importância de previsibilidade regulatória após adiamento da Resolução CMED nº 3/2025

Interfarma destaca papel do acesso sustentável à inovação na edição especial do Global Forum 2026

Interfarma e Correio realizam Summit Propriedade Intelectual na Agenda Pública; confira a agenda

Defining Leadership for Oneself is Key to Becoming a Leader, ACRP 2026 Panelists Say

ABPI celebrates a month of major investment commitments into UK life sciences

Attendees Encouraged to “Act with Courage, Driven by Purpose” as ACRP 2026 Closes

La AEMPS informa del cese de comercialización y la retirada del mercado de Deliplus Men Depil bajo la ducha

Prorrogação da entrada em vigor da Resolução CMED nº 3/2025 é positiva, avalia Interfarma

MHRA Safety Roundup: April 2026

Good laboratory practice (GLP) for safety tests on chemicals

ANMAT cancela la habilitación de la firma REHUE S.A. y prohíbe la comercialización de sus productos

ANMAT suspendió el certificado de buenas prácticas de la firma ELECTRON PLAST S.A. y prohibió la comercialización de productos de terceros con destino a tránsito interjurisdiccional

Ανακοίνωση σχετικά με την Ευρωπαϊκή Βάση Δεδομένων Ι/Π- EUDAMED

Aπαγόρευση διάθεσης και διακίνησης των προϊόντων

Eκτέλεση προϋπολογισμού μηνός Μαρτίου 2026

La AEMPS adecúa los formatos de antibióticos para alinearlos con las pautas clínicas habituales y evitar su uso inapropiado

Boletín sobre Cosméticos, Biocidas AEMPS y Productos de Cuidado Personal. Enero-marzo 2026

Across the Codes: Navigating MedTech Compliance Expectations in the Region

Wegovy and Mounjaro for weight loss not funded

Clinical investigations for medical devices

Class 2 Medicines Recall: Amarox Limited, Sertraline 100mg film-coated tablets, EL(26)A/22

Γενόσημα Μαρτίου 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση

Ανάκληση των παρτίδων του συνημμένου πίνακα του Ιατροτεχνολογικου προϊόντος, MDD Class IIΙ, 16F Dual—Valved Splittable Sheath Introducer

Transparency data: MHRA Performance Data

Corporate report: MHRA Results and Forecast 2025/26; 2026/27

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines

Clinical trials for medicines: non-investigational medicinal products

Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products

Guidance: Clinical Trials Regulations enforcement provisions

Guidance: Clinical trials for medicines: roles and responsibilities

Guidance: Clinical trials for medicines: Archiving and retention of clinical trial records

Clinical trials for medicines: notifiable trials

Clinical trials for medicines: labelling

Clinical trials for medicines: Good clinical practice inspections

Guidance: Clinical trials for medicines: International Council for Harmonisation (ICH) annotations

Guidance: Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol

Guidance: Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment

Leading the Cut: 4 Organizations Take on Site Training Reduction

US legislative reforms needed to make biosimilars competitive

Νέα ΣΥΦΑ 1ου Τριμήνου 2026 _ Τιμολόγηση Φαρμακευτικών Προϊόντων

Boletín sobre Productos Sanitarios. Enero-marzo 2026

ACRP 2026 Panelists Encourage Attendees to “Embrace the Now, Ignite What’s Next”

KOMENTARZ z okazji Światowego Dnia Własności Intelektualnej. prof. Rafał Sikorski, Uniwersytet im. Adama Mickiewicza w Poznaniu

Γενόσημα Φεβρουάριος 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση

La AEMPS informa del cese de comercialización, retirada del mercado y recuperación de la tinta para tatuaje Dynamic Candy Apple Red

Attention aux confusions entre flacons

[ANZEN]PMDA Medical Safety Information: Use of Insulin-Specific Syringe- Incorrect dose may cause serious adverse health effects- posted

[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (General Chapters) updated

[YAKKYOKUKATA]Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs) updated

[KOKUSAI]Information on PMDA Asia Office updated

“What Got Us Here, Won’t Get Us There,” and Other Insights on the Clinical Research Workforce Shared at ACRP 2026

Suspensión de Servicios

ANMAT facilita la importación de productos necesarios para el desarrollo de estudios clínicos

Behind the Budget: What Sites Really Need to Know Today

Why Site Support Goes Unused in Clinical Trials

Mobility in Clinical Trial Operations with the SIP Mobile App: Practical Gains, New Friction Points, and What to Watch

Cardiometabolic Trials are Exposing a Flaw in the Clinical Research Model: Retention is Engineered Upstream

Bridging Innovation and Reality: Why Human Support Is Essential in Tech-Enabled Clinical Trials

Class 3 Medicines Recall: Omega Pharma Ltd, Napralief 250mg Gastro-Resistant Tablets, EL(26)A/21

Γενόσημα Ιανουάριος 2026 _ Προτεινόμενες Τιμές προς Διαβούλευση

La AEMPS informa de un posible error de software en las versiones 1.5 a 1.6 de la aplicación Dexcom One+ iOS

Επικοινωνία σχετικά με την οριστική διακοπή κυκλοφορίας επιλεγμένων σκευασμάτων ινσουλίνης

A free gene therapy? Regeneron’s Otarmeni approved for hearing loss

FDA, CMS partner to deliver RAPIDly for innovative devices

Field Safety Notices: 13 to 17 April 2026

El presidente del CSSP, Lic. Daniel Quinteros, junto con equipo técnico realiza visita a el Instituto Especializado Hospital El Salvador (IEHES)

La AEMPS informa de un posible error en las versiones 2.9.0 a 2.11.2 de las aplicaciones Dexcom G7 iOS y Dexcom G7 Watch iOS

La AEMPS informa del cese de comercialización, retirada del mercado y recuperación de los cosméticos Blonde Henna y Oil Balance, de la marca Real Earth

4S (κάψουλες) (SIBUTRAMINE, PHENOLPHTALEIN)

Boletín sobre Seguridad de Medicamentos de Uso Humano. Febrero de 2026

BABA BERATAN HERBAL MIXTURE, GENTLE DMP DOMIPA HERBAL MIXTURE, MANISA HERBAL MIXTURE, BITKISEL KARISIMLI EPIMEDYUMLU MACUN, LA PEPA NEGRA, ROYAL HONEY

Webinaires EUDAMED : formation aux modules Acteurs, UDI/Dispositifs et Organismes notifiés/Certificats

Απαγόρευση διάθεσης και διακίνησης των συμπληρωμάτων διατροφής YAVA LABS – FAT BURNER BLUEBERRY και YAVA LABS – FAT BURNER COLA

Agenda for May 2026 Immunisation Advisory Committee (IAC) meeting

Información Electrónica de Prescripción (ePI): Acelerando la Transformación Digital de los Sistemas de Salud en América Latina

CMS to Bridge coverage for obesity drugs as BALANCE teeters

La AEMPS informa del lanzamiento de un programa piloto de la EMA para impulsar el desarrollo de productos sanitarios y productos sanitarios in vitro innovadores

La AEMPS informa de la detección de productos sanitarios falsos bajo las marcas GEBRO-Mesoceuticals y VANE-Mesoceuticals en el mercado europeo

ANMAT suspende el certificado de BPF y prohíbe la comercialización de productos médicos de la firma RIPEZZI S.R.L.

ANMAT dispuso la suspensión de habilitaciones de la firma BIOGAMMA S.R.L.

Class 4 Medicines Defect Notification: Doncaster Pharma Limited, Hiprex 1g tablets, EL(26)A/20

Ανάκληση της Άδειας Χονδρικής πώλησης φαρμάκων για Ανθρώπινη Χρήση στο πρατήριο της εταιρείας ΕΝΟΡΑΣΙΣ ΑΕ

Ανάκληση των παρτίδων 17270129, 17363725, 17385132, του φαρμακευτικού προϊόντος VISIPAQUE INJ.SOL 625 MG(320MG I)/ML BTx1 USB BOTTLE x 100ml

Έντυπα & Διαδικασίες Τμήματος Τιμολόγησης (τελ.τροπ.23-4-2026)

Xuanzhu shares dip despite phase III ALK inhibitor data

Biogen amasses full felzartamab rights with $850M TJ deal

La AEMPS establece los requisitos técnicos para el registro de medicamentos veterinarios no biológicos

ANMAT suspende la habilitación para la distribución interjurisdiccional de medicamentos de la firma GLOBAL PHARMA GROUP S.A.

La AEMPS desmiente el “callo solar” y recuerda la importancia de una exposición solar segura

Boletín del Comité de Medicamentos de Uso Humano. Marzo de 2026

Ενημέρωση για την υποβολή των αιτημάτων τιμολόγησης

Statutory guidance: MHRA fees

[ANZEN]Revisions of PRECAUTIONS: Infliximab (genetical recombination) and biosimilars , etc. posted

Xuanzhu shares dip despite phase III ALK inhibitor data

Psychedelic space expanding on Trump’s EO

Decision: Marketing authorisations Granted in 2026

Reunión del Comité de Medicamentos de Uso Humano de abril de 2026

Decision: Parallel import licences granted in 2026

Class 2 Medicines Recall: Crescent Pharma Limited, Ramipril 10mg capsules, EL(26)A/19

La UE abre consulta pública sobre la propuesta de restricción de las PFAS

[KOKUSAI]A new page for the Regulatory Symposia has been launched.

Agenda for May 2026 Pharmacology and Therapeutics advisory committee (PTAC) meeting

New nominee may need a charm at the CDC

Allergovit 123 Parietaria 100% suspensión inyectable, en su formato de Mantenimiento de 2 viales, concentración B (10.000 UT/ml)

Ανάκληση παρτίδων των καθετήρων μπαλονιού κρυοκατάλυσης POLARx και POLARx FIT, των κατευθυνόμενων θηκαρίων POLARSHEATH

La AEMPS informa de retrasos en el restablecimiento del suministro de Tenormin 0,5 mg/ml solución inyectable

Κύρια σημεία συνεδρίασης της Επιτροπής Αξιολόγησης Κινδύνου Φαρμακοεπαγρύπνησης (PRAC), 7 – 10 Απριλίου 2026

Promotional material: National AI Commission: Ask Me Anything

Dispositifs médicaux et dispositifs médicaux de diagnostic in vitro : un arbre décisionnel pour aider les acteurs concernés par l’article 10bis des règlements européens

Ανάκληση του συμπληρώματος διατροφής MemoVigor2, δισκία, με αρ. παρτίδας Ι015 και ημερομηνία λήξης 02/2027

HHS budget hearing not so much about budget

CSPC’s SYS-6051 cleared for clinic in China for solid tumors

China’s NMPA accepts Mabwell’s IND application for 6MW5311

Tulipe et le Snitem signent un partenariat pour renforcer la mobilisation des industries de santé dans l’aide médicale humanitaire

Clinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom

Clinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom

Clinical trials for medicines: guidance on quality and risk proportionality

Δήλωση Αποθεμάτων Φαρμάκων Ανθρώπινης Χρήσης

Flash VIG-news - Vaccin Ixchiq contre le chikungunya : rappel des recommandations

Transparency data: MHRA annual accountability review minutes

Flow of Trump EOs slowing way down

Recherche & industrie : le rêve d’une France souveraine, à l’épreuve des choix

Guidance: RSV Vaccine Factsheet – Information for Patients, Parents and Carers

Mabwell announces Chinese clinical trial clearance for SST-001

Actualizaciones del Código Alimentario Argentino

Ανάκληση της παρτίδας EM1425 του καλλυντικού προϊόντος NEPTUNE AFTER SHAVE

Ανάκληση της παρτίδας 333570 του συμπληρώματος διατροφής HEALTHAID HAEMOVIT, Liquid Gold Blackcurrant taste

Reunión del Comité de Medicamentos Veterinarios de abril de 2026

Managing Financial Risk at the Site Level: Practical Strategies for Underfunded Studies

The Need for Clinical Research Sites to Transition to e-Regulatory Binders: Strategies, Pros, and Cons

Measuring Quality in the Age of AI: Why Regulatory Writing Needs a True Standard

Enhancing the Quality of Investigator-Initiated Trials Through Self-Study Modules

From Mapping Your Pathway to Traversing a Career

Empowering Research-Naïve PIs for Complex and Advanced Therapeutic Trials

The Cost of Turnover in Clinical Operations: What Leaders Can Actually Do About It

Using AI to Unlock New Opportunities in Clinical Data Recruitment and Talent Development

A Practical Guide to Patient-Centric Trials Using Net Treatment Benefit

The Recurring Conundrum of Diversity: Targeted Precision as an Economically Calculable Strategy

Guidance: Declaration of Helsinki and Clinical Trial Regulations alignment

Guidance: Archiving and retention of clinical trial records

Interfarma no HBR Summit Brasil: painel debate cuidado baseado em valor como eixo para inovação e sustentabilidade

Interfarma no HBR Summit Brasil: cuidado baseado em valor é caminho para mais eficiência e melhores desfechos em saúde

Nuevos proyecto de consulta para la opinión pública

Medicines: Get integrated scientific advice from the MHRA and NICE

[ANZEN]MHLW Pharmaceuticals and Medical Devices Safety Information No.428 posted

Field Safety Notices: 6 to 10 April 2026

Repenser la santé depuis les territoires : le signal venu de Dunkerque

Decision: Triheptanoin in the treatment of long-chain fatty acid oxidation disorders (LC-FAOD)

El Informe Anual sobre Cosmetovigilancia registra un aumento del 30% de las notificaciones por efectos no deseados de productos cosméticos

Decision: Marketing authorisations granted in 2025

[IBENTO][IBENTO]The report for the PMDA-ATC Pharmacovigilance Seminar 2026 has been posted.

[KOKUSAI]The report for the APEC CoE workshop: PMDA-ATC Pharacovigilance Seminar 2026 has been posted.

Register medical devices to place on the market

Decision: Advertising investigations: March 2026

Kennedy expands ACIP function, membership criteria

ANMAT concluyó el proceso para la baja definitiva de las firmas HLB PHARMA GROUP S.A. y LABORATORIOS RAMALLO S.A.

CENRIFKI

[SHINSA]Considerations for clinical development of intravenous formulations containing the same active ingredient as oral products for patients who are temporarily unable to receive oral administration in epilepsy treatment （Early consideration） posted

Guidance: Get medicines to NHS patients earlier via the MHRA-NICE aligned pathway

National assessment procedure for medicines

Simplificación de los mecanismos de inscripción para productos importados cosméticos, domisanitarios e higiénicos

La AEMPS informa del cese de comercialización, retirada del mercado y recuperación de un lote del cosmético Agrado crema solar SPF 50

Onbeschikbaarheid van Fibclot 1,5 g poeder en oplosmiddel voor injectie/infusie: aanbevelingen voor artsen-specialisten en ziekenhuisapothekers

Pharmac to fund two new combination treatments, and widen access to another, for people with a type of blood cancer

31 March 2026WHO Model RMP Assessment Tools Standard Operating Procedure (SOP)WHO Model RMP Assessment Tools Standard Operating Procedure (SOP)

Publications of the World Health Organization

8 January 20262025 November ACSoMP recommendations2025 November ACSoMP recommendations

Report of the Meeting of the WHO Advisory Committee on Safety of Medicinal Products, 24-25 November...

9 April 2026Departmental updateKazakhstan becomes first country in Central Asia to earn WHO recognition for regulation of medicines and imported vaccines

Kazakhstan has achieved a major public health milestone, becoming the first country in Central Asia...

Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination

Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3)...

Patient Listening Session Summaries

Patient Listening Session summaries are published after each session to share a high-level summary o...

FDA approves safety labeling changes for opioid pain medicines

Today, FDA is announcing final approval and immediately effective implementation of required labelin...

FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain

FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the leg...

FDA's ISTAND Pilot Program accepts submission of first artificial intelligence-based and digital health technology for neuroscience

FDA's Center for Drug Evaluation and Research (CDER) recently accepted a new submission into the Inn...

FDA revises letter of authorization for the emergency use authorization for Paxlovid

FDA revises letter of authorization for the emergency use authorization for Paxlovid

ACRP Fellow Touts the Benefits of Bringing Clinical Research Stakeholders Together

FDA issues guidance regarding drug development for early Alzheimer’s disease

FDA issues guidance regarding drug development for early Alzheimer’s disease

FDA Announces New Quality Oversight Webpage

FDA Announces New Quality Oversight Webpage

FDA establishes CDER Center for Clinical Trial Innovation (C3TI)

FDA establishes CDER Center for Clinical Trial Innovation (C3TI), which will promote CDER clinical t...

FDA issues agency-initiated proposed order regarding OTC monograph drugs containing acetaminophen

Today, FDA issued a proposed administrative order, to address a safety issue related to over-the-cou...

FDA updates guidance on interchangeability

FDA issued a draft guidance for industry “Considerations for Demonstrating Interchangeability with a...

FDA's ISTAND Pilot Program accepts a submission of first organ-on-a-chip technology designed to predict human drug-induced liver injury (DILI)

FDA accepts first letter of intent (LOI) into the ISTAND Pilot Program for an organ-on-a-chip techno...

FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize

The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucag...

FDA approves REMS modification, advancing new drug disposal option

FDA approves risk evaluation and mitigation strategy (REMS) modification, advancing new drug disposa...

UK formalizes zero tariffs deal with US, will pay more for drugs

Field Safety Notices: 30 March - 3 April 2026

LOTUS PREMIUM HONEY MIXED HERBAL PASTE WITH HONEY

Boletín sobre Medicamentos Veterinarios. Enero-Marzo 2026

Ανάκληση της παρτίδας 111572333 βρεφικού γάλακτος ALMIRON PROFUTURA 1

MHRA expands AI Airlock programme with a £3.6 million funding boost over three years

The MHRA continues to be at the forefront of innovation and secures multi-year funding to expand its...

Ανάκληση παρτίδων του ιατροτεχνολογικού προϊόντος VELFIX EDGE 6cmX7cm (REF 5502A) Διάθεση στην αγορά: NEUROMED MEDICAL SUPPLIES