Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and MHRA MHRA has detailed the changes made to the guidance which clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP) on 1 January 2025. Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and MHRA
European Medicines Agencies Network Strategy to 2028 – Webinar The presentations and recording of the webinar on the European Medicines Agencies Network Strategy (EMANS) to 2028 have been published. European Medicines Agencies Network Strategy to 2028 – Webinar
AESGP Hearing with EMA HMPC September 2024 – Report The report of the AESGP hearing with the EMA Committee on Herbal Medicinal Products (HMPC) that took place on 25 September 2024 has been published. AESGP Hearing with EMA HMPC September 2024 – Report
Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and the MHRA The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the guidance that clarifies he expectations on the application of the EU guidance on good pharmacovigilance practices (GVP). Updated MHRA Guidance on Exceptions and Modifications to EU Good Pharmacovigilance Practices for UK MAHs and the MHRA
Updated MHRA Category 1 List Following the Implementation of the Windsor Framework The Medicines and Healthcare products Regulatory Agency (MHRA) has updated the Category 1 list to include authorisations granted in December 2024. Updated MHRA Category 1 List Following the Implementation of the Windsor Framework
Draft EU Herbal Monograph on Hyperici herba/Cimicifugae rhizome Further to its adoption by the EMA Committee on Herbal Medicinal Products (HMPC) in January 2025, the draft EU herbal monograph on Hyperici herba/Cimicifugae rhizome has been published for public consultation. Draft EU Herbal Monograph on Hyperici herba/Cimicifugae rhizome
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
