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
EMA Public Launch of Guideline on Good Pharmacovigilance Practices The European Medicines Agency (EMA) is hosting a virtual event on 11 September 2024 to present the revised Guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II. EMA Public Launch of Guideline on Good Pharmacovigilance Practices
EMA-AESGP Bilateral – April 2024 – Highlights Published The European Medicines Agency (EMA) has published the highlights from the fifth EMA-AESGP bilateral meeting held on 29 April 2024. EMA-AESGP Bilateral – April 2024 – Highlights Published
CMDh June 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 25-26 June 2024. CMDh June 2024 Meeting – Report
EMA New Fee Regulation – Working Arrangements The European Medicines Agency (EMA) Management Board adopted several documents in June 2024 in preparation for the New Fee Regulation (Regulation (EU) 2024/568) on fees and charges payable to the Agency coming into effect as of 1 January 2025. EMA New Fee Regulation – Working Arrangements
