EMA Consultation – Reflection Paper Linking to ePI from EU Medicine Packages The European Medicines Agency (EMA) has released for public consultation its Reflection paper on linking to electronic product information (ePI) from EU medicine packages. The official deadline for comments is 30 June 2025. EMA Consultation – Reflection Paper Linking to ePI from EU Medicine Packages
UK Clinical Trials Regulations Signed into Law New regulations for running clinical trials in the UK have now been signed into law. A 12-month roll-out began on 11 April to deliver a significant update to UK clinical trials regulation, with the aim of strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research. UK Clinical Trials Regulations Signed into Law
DHSC – Value Based Procurement Market Engagement Exercise One of the Department of Health and Social Care (DHSC)'s key MedTech initiatives is Value Based Procurement (VBP). The DHSC VBP team are hosting 2 hour long Q&A sessions with MedTech suppliers. The sessions will take place on 7 May 11am - 12pm and 13 May 3 - 4pm. DHSC – Value Based Procurement Market Engagement Exercise
DBT – Request for Input on Potential UK Measures in Response to US Tariffs The Department for Business and Trade (DBT) is seeking input from stakeholders on potential UK measures in response to recent US tariff announcements. DBT – Request for Input on Potential UK Measures in Response to US Tariffs
EU Life Sciences Strategy – Call for Evidence The European Commission has opened a Call for Evidence on the EU Life Sciences Strategy, closing 17 April 2025. EU Life Sciences Strategy – Call for Evidence
EMA – Real-world Evidence The European Medicines Agency (EMA) has published a reflection paper on the use of real-world data in non-interventional studies to generate real-world evidence (RWE) and a document detailing progress and the journey towards a roadmap for regulatory guidance on RWE. EMA – Real-world Evidence
MHRA Guidance on National Assessment Procedure for Marketing Authorisation Applications The MHRA has published a guidance on the national assessment procedure for marketing authorisation (MA) applications. MHRA Guidance on National Assessment Procedure for Marketing Authorisation Applications
MHRA Publishes Updated Statutory Fees for Medicines (2025–2027) The MHRA has published updated statutory fees for medicines, following a public consultation and response process. MHRA Publishes Updated Statutory Fees for Medicines (2025–2027)
CMDh Report – March 2025 Meeting The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the meeting held on 25-26 March 2025. CMDh Report – March 2025 Meeting
MHRA Marketing Authorisations Granted 15 to 31 March MHRA granted 1 OTC licence during 15-31 March 2025. MHRA Marketing Authorisations Granted 15 to 31 March
Regulatory Fees for British Chemicals Sector Reduced New legislation to cut UK REACH costs for chemical businesses has come into force as part of the Government’s Plan for Change. Regulatory Fees for British Chemicals Sector Reduced
Commission Report on the Work of HERA The EC has published a report assessing the work of the Commission's Health Emergency Preparedness and Response Authority (HERA) since its creation over three years ago. Commission Report on the Work of HERA
