UK – MHRA approves first UK treatment for congenital thrombotic thrombocytopenic purpura (cTTP)
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (12 May 2025) approved rADAMTS13 (ADZYNMA), the first UK treatment to treat congenital thrombotic...
International – International group proposes best practices for AI in pharmacovigilance
The Council for International Organizations of Medical Sciences (CIOMS) has issued a draft report detailing a set of best practices to guide the integration...
Europe – EMA proposes to incorporate Annex 1 in GMP guide for ATMPs
The European Medicines Agency (EMA) plans to release a draft guideline that will integrate Annex 1 into Part IV of the Guidelines on Good...
France – Grippe saisonnière : la HAS précise la place des vaccins Efluelda et...
Infection respiratoire aigüe, la grippe saisonnière provoque chaque année un nombre important de décès et d'hospitalisations, notamment chez les personnes âgées, et une tension...
Switzerland – Swissmedic mandates nitrosamine risk assessments in some applications
The Swiss Agency for Therapeutic Products (Swissmedic) has updated guidance on nitrosamines to clarify when new authorization applications must include a risk assessment.
Swissmedic added...
USA – FDA to expand unannounced foreign inspections after Trump executive order
The US Food and Drug Administration (FDA) on Tuesday announced it will expand its effort to conduct unannounced inspections of foreign manufacturing facilities that...
Europe – Product Management Service (PMS) – Implementation of International Organization for Standardization (ISO)...
This document provides detailed guidance on the data elements and associated business rules applicable to:
• the submission of information of authorised medicinal products...
Europe – Leveraging the power of data for public and animal health
EMA and the Heads of Medicines Agencies (HMA) have published a joint workplan "Data and AI in medicines regulation to 2028". It sets out how the European...
UK – MHRA approves teprotumumab as the first UK treatment for adults with moderate...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 7 May 2025, approved teprotumumab (Tepezza). This is the first medicine to be licensed...
Europe – EMA starts review of Ixchiq (live attenuated chikungunya vaccine)
EMA’s safety committee (PRAC) has started a review of Ixchiq (a live attenuated chikungunya vaccine) following reports of serious adverse events in elderly people.
Many of the...
