Changes to the way the UK ePI Task Force works The 3 trade associations leading the UK ePI Task Force - PAGB, ABPI and BGMA - have provided an update on how the Task Force will operate in the future. Changes to the way the UK ePI Task Force works
MHRA PIQU RFI Update The MHRA PIQU team has confirmed going forwards only 1 Request for Further Information (RFI) letter will be issued. MHRA PIQU RFI Update
Smarter Regulation Update DBT has published two policy papers "Smarter Regulation: Delivering a regulatory environment for innovation, investment and growth" and "Smarter Regulation: One Year On – May 2024". Smarter Regulation Update
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
