MHRA – Medicines Pipeline Data MHRA is requesting that current or potential medicines Marketing Authorisation Holders provide information on planned or potential future submissions to MHRA. MHRA has published guidance which details how, what, and why MHRA require this data. MHRA – Medicines Pipeline Data
MHRA – Pre-submission Advice & Support MHRA has published guidance on pre-submission advice before applying for medicines Marketing Authorisations. MHRA – Pre-submission Advice & Support
MHRA Windsor Framework Readiness Message and DHSC Survey MHRA has shared a reminder of the preparations required regarding labelling changes under the Windsor Framework ahead of 1 January 2025. MHRA Windsor Framework Readiness Message and DHSC Survey
MHRA – Invoicing System Issue MHRA has discovered there is currently an IT issue which is causing the issuing of incorrect invoices. MHRA – Invoicing System Issue
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
