May 2025 – Contents
Advanced therapies: A maturing regulatory framework
Gene Therapy Medicinal Products: An examination of regulatory CMC requirements
Recent advances and the near-term outlook for Advanced Therapy Medicinal Products in cancer treatment
Case studies: The impact of the In Vitro Diagnostic Regulation on ATMP clinical trials and drug development plans
Navigating the FDA’s platform technology designation: Key insights and best practices for drug manufacturers
Navigating orphan drug designation in the EU
Prescribing efficiency: Using generative artificial intelligence for pharmacovigilance
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MHRA provides guidance to streamline safety communication
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
Key milestone reached in African medicines regulation
A key milestone for medicines regulation in Africa has been reached with the first continental listing of five medicinal products by the African Medicines Regulatory Harmonisation (AMRH) Steering Committee.
Rui Santos Ivo elected as new Chair of the EMA Management Board
Rui Santos Ivo has been elected as the new Chair of the European Medicines Agency (EMA) Management Board. Mr Santos Ivo takes over from Lorraine Nolan, who completed her tenure on 21 March 2025.
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EMA establishes new standard procedure for high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of high-risk Class III and Class IIb medical devices to request scientific advice.
EMA accepts new guidelines on investigational ATMPs
The European Medicines Agency (EMA) has adopted the Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials, which officially comes into effect on 1 July 2025.
RegRapPod − InConversation with Ivo Claassen
InConversation talks veterinary regulation with Ivo Claassen, Head of the Veterinary Medicines Division at the EMA
RegRapPod − InConversation with the UK ePI Task Force
InConversation talks electronic product information with Andrew Burgess and Michael Clarke
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