MHRA Announces Dedicated New Team to Support the International Community in Tackling Antimicrobial Resistance MHRA's specialized team to support the international community combat the growing threat of antimicrobial resistance (AMR). MHRA Announces Dedicated New Team to Support the International Community in Tackling Antimicrobial Resistance
A message from MHRA – Windsor Framework Labelling Changes MHRA's message to companies outlines the labelling preparations required under the Windsor Framework ahead of 1 January 2025. A message from MHRA – Windsor Framework Labelling Changes
BIVDA Webinar – An Introduction to the Procurement Act 2023 MHRA has published the recording of the webinar on the established medicines licensing process, which took place in April 2024. BIVDA Webinar – An Introduction to the Procurement Act 2023
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
Webinar Recording – Established Medicines Licensing Process MHRA has published the recording of the webinar on the established medicines licensing process, which took place in April 2024. Webinar Recording – Established Medicines Licensing Process
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
