MHRA AI Strategy Paper Published MHRA has published its strategic approach to AI, setting out how MHRA approaches AI as a regulator of AI products. MHRA AI Strategy Paper Published
CMDh April 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 23-25 April 2024. CMDh April 2024 Meeting – Report
Updated Annex to Excipients Guideline – Proline & Polysorbates The European Medicines Agency (EMA) has published a revised version of the Annex to the excipients guideline. The April 2024 revision includes two new excipients: proline and polysorbates. Updated Annex to Excipients Guideline – Proline & Polysorbates
UK ePI Task Force Update Bulletin – April 2024 The UK ePI Task Force April 2024 bulletin has been published. The UK ePI Task Force is an initiative led by PAGB, BGMA and ABPI to facilitate a move to user-centred, digital-first medicines information for patients. UK ePI Task Force Update Bulletin – April 2024
Communication by the Commission on Essential Use Concept & EEA/ECHA Indicator Framework to Assess Chemical Pollution The Commission has published a communication on guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals and the European Environment Agency (EEA) and the European Chemicals Agency (ECHA) Indicator have published a framework in support of the transition to safe and sustainable chemicals. Communication by the Commission on Essential Use Concept & EEA/ECHA Indicator Framework to Assess Chemical Pollution
MSSG Recommendations to Strengthen Supply Chains of Critical Medicines Published EMA has published a set of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain. MSSG Recommendations to Strengthen Supply Chains of Critical Medicines Published
MHRA Marketing Authorisations Granted 1 to 14 April 2024 MHRA granted 2 OTC licenses during 1 - 14 April 2024. MHRA Marketing Authorisations Granted 1 to 14 April 2024
MHRA – Lorenz Docubridge Validation Tool MHRA has added details of the Lorenz Docubridge validation tool to the guidance 'Medicines: apply for a variation to your marketing authorisation' and 'Apply for a licence to market a medicine in the UK'. MHRA – Lorenz Docubridge Validation Tool
MHRA Newsletter April 2024 MHRA has published the April edition of MHRA News, the monthly newsletter for industry. MHRA Newsletter April 2024
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
MHRA Publishes Marketing Authorisations Granted From 15 to 31 March 2024 MHRA granted one new OTC licence between 15 and 31 March. MHRA Publishes Marketing Authorisations Granted From 15 to 31 March 2024
EMA Guidance on Real-World Evidence Provided by EMA EMA has published a guidance on real-world evidence provided by EMA: support for regulatory decision-making. EMA Guidance on Real-World Evidence Provided by EMA
