EMA Work Plans The EMA Quality Working Party (QWP) has published its 3-year work plan for 2025-2027. In addition, the EMA Non-clinical Working Party has published its 3-year rolling work plan for the Non-clinical domain for 2025-2027. EMA Work Plans
EMA HMPC Meeting Report – January 2025 The report from the EMA Committee on Herbal Medicinal Products (HMPC) meeting held on 20-22 January 2025 has been published. EMA HMPC Meeting Report – January 2025
MHRA Performance Data for Assessment of New Marketing Authorisations, Variations and Clinical Trial Authorisation The MHRA performance metrics for new marketing authorisation applications, variations, and clinical trial authorisation assessment have been updated. MHRA Performance Data for Assessment of New Marketing Authorisations, Variations and Clinical Trial Authorisation
EMA Reflection Paper on Qualification of Non-mutagenic Impurities EMA has published a draft reflection paper on the qualification of non-mutagenic impurities for public consultation. This paper reflects on the product-specific qualification of non-mutagenic impurities in chemically synthesised pharmaceuticals. EMA is organising a webinar on 6 March to explain the main new elements of the updated paper. EMA Reflection Paper on Qualification of Non-mutagenic Impurities
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
