MHRA Marketing Authorisations Granted 15 to 31 January MHRA granted 4 OTC licences during 15 to 31 January 2025. MHRA Marketing Authorisations Granted 15 to 31 January
MHRA – RWE Scientific Dialogue Programme EOI Form MHRA is launching a pilot Real-World Evidence (RWE) Scientific Dialogue Programme during 2025 which is designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations. An Expression of Interest (EOI) form has now been added as EOIs will be accepted from 10 February 2025 until 11.59pm BST 4 April 2025. MHRA – RWE Scientific Dialogue Programme EOI Form
Commission Announces Action for Safe and Sustainable e-Commerce Imports The Commission is taking action to tackle risks stemming from low-value imports sold via non-EU online retailers and marketplaces hosting non-EU traders. These actions are part of the Communication on E-Commerce, ‘A Comprehensive EU Toolbox for Safe and Sustainable E-commerce', which the Commission is proposing. Commission Announces Action for Safe and Sustainable e-Commerce Imports
CMDh Report – January 2025 Meeting The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the meeting held on 28-30 January 2025. CMDh Report – January 2025 Meeting
European Health Data Space Webinars The EU Health Policy Team of the European Commission is hosting a series of webinars on the European Health Data Space. European Health Data Space Webinars
UK ePI Task Force Update The UK ePI Task Force is co-led by PAGB, ABPI and BGMA and is working for user-centred, digital-first medicines information. An update from the Task Force has been shared. UK ePI Task Force Update
EMA – Questions & Answers on Article 117 – Fifth Revision Published EMA has updated its guidance on the implementation of EU regulations on medical devices and in vitro diagnostic medical devices to address situations when a declaration of conformity is not available for class I integral medical devices. EMA – Questions & Answers on Article 117 – Fifth Revision Published
AESGP Webinar – Interruption or Discontinuation of Supply Under Article 10a MDR: Practical Guidance On 27 February, AESGP is hosting a webinar on the interruption or discontinuation of supply under Article 10a MDR. AESGP Webinar – Interruption or Discontinuation of Supply Under Article 10a MDR: Practical Guidance
UK-wide Licensing for Human Medicines: Supplementary Guidance Published MHRA has published supplementary information on the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. UK-wide Licensing for Human Medicines: Supplementary Guidance Published
HPRA – Guide to Labels and Leaflets of Human Medicines The Health Products Regulatory Authority (HPRA) has published an updated guide to labels and leaflets of human medicines. HPRA – Guide to Labels and Leaflets of Human Medicines
European Shortages Monitoring Platform Fully Live The European Shortages Monitoring Platform (ESMP) has now gone fully live. MAHs can now log in and begin using the platform. European Shortages Monitoring Platform Fully Live
EMA Publishes Final Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs) EMA has released the final guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs). EMA Publishes Final Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs)
