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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EMA to address antimicrobial resistance risks from veterinary medicinal products
The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing AMR from VMPs via the environment.
MHRA authorises new cancer treatment variation with significantly reduced administration time
On 30 April 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) authorised a new under-the-skin injection variation of nivolumab (OPDIVO). This offers a quicker administration of the treatment for eligible patients.
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.’
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MHRA appoints new Chief Executive Officer
Lawrence Tallon has been appointed the new Chief Executive Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) and will begin the role on 1 April 2025.
MHRA approves Nemolizumab for eczema patients in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nemolizumab, also known as Nemluvio, to help with the treatment of atopic dermatitis (eczema) in the UK.
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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