MHRA Board Members and Committee Lists Updated The MHRA has updated the board members and committee list on their website. MHRA Board Members and Committee Lists Updated
ESMP Webinar The European Medicines Agency (EMA) is organising a series of events throughout 2024 and 2025 for stakeholders on the European Shortages Monitoring Platform (ESMP). The first webinar is scheduled for 24 June. ESMP Webinar
MHRA Marketing Authorisations Granted 1 to 14 May 2024 MHRA granted 6 OTC licenses during 1 - 14 May 2024. MHRA Marketing Authorisations Granted 1 to 14 May 2024
Brexit Working Group Meeting Michelle Riddalls, CEO of PAGB, hosted an ad hoc meeting of the EU Exit Working Group to update on the EU Acquis implementation for medicines within the Windsor Framework. Brexit Working Group Meeting
EMA Q&A Document on Article 117 – 4th Revised Version Published EMA has published the fourth revised version of its questions & answers document on Article 117 MDR (practical considerations concerning combination products). EMA Q&A Document on Article 117 – 4th Revised Version Published
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
