MHRA – Windsor Framework Readiness Message MHRA has shared a reminder of the preparations required with respect to labelling changes under the Windsor Framework ahead of 1 January 2025. MHRA – Windsor Framework Readiness Message
EMA – Guideline on Good Pharmacovigilance Practices The European Medicines Agency (EMA) has published Guideline on good pharmacovigilance practices: Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures. EMA – Guideline on Good Pharmacovigilance Practices
Use of Real-World Evidence in Regulatory Decision Making – Second EMA Report Published A second report based on studies the European Medicines Agency (EMA) conducted using real-world data (RWD) between February 2023 and February 2024 has been published. The report summarises the progress made to enable the use of RWD and establish its value in regulatory decision-making by 2025. Use of Real-World Evidence in Regulatory Decision Making – Second EMA Report Published
MHRA & British Pharmacopoeia Reports MHRA has published the Annual conflict of interest compliance report 2023/24 and MHRA annual report and accounts 2023 to 2024. In addition, the British Pharmacopoeia Commission Annual Report 2023 has also been published. MHRA & British Pharmacopoeia Reports
International Recognition Procedure – IRP Lifecycle Validation Checklist Updated MHRA has updated the International Recognition Procedure (IRP) lifecycle validation checklist. International Recognition Procedure – IRP Lifecycle Validation Checklist Updated
UK Environmental Improvement Plan The UK Government has publishes the Environmental Improvement Plan (EIP) Annual Progress Report. UK Environmental Improvement Plan
Windsor Framework: Medicines Statutory Instrument Laid The Department of Health and Social Care has laid The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, which implements the Windsor Framework changes for medicines in UK law. Windsor Framework: Medicines Statutory Instrument Laid
MHRA May and July Board Meeting Documents The agenda and board papers from the MHRA board meeting on 21 May and 9 July 2024 have been made available. MHRA May and July Board Meeting Documents
CMDh July 2024 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 23-24 July 2024. CMDh July 2024 Meeting – Report
Important Changes to PAGB Regulatory Inboxes The PAGB food supplement inbox (foodsupplements@pagb.co.uk) has now been merged with the PAGB regulatory inbox (regulatory@pagb.co.uk). Important Changes to PAGB Regulatory Inboxes
MHRA Marketing Authorisations Granted 15 to 30 June MHRA granted 4 OTC licenses during 15-30 June 2024. MHRA Marketing Authorisations Granted 15 to 30 June
MHRA Performance Data for Assessment of Clinical Trials and Established Medicines The MHRA performance metrics for clinical trials and established medicines assessment have been updated. MHRA Performance Data for Assessment of Clinical Trials and Established Medicines
