RWD & RWE in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences Working Group XIII A report summary from the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII on Real-World Data (RWD) and Real-World Evidence (RWE) has been published in the Pharmacoepidemiology and Drug Safety (PDS) journal. RWD & RWE in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences Working Group XIII
Study on Availability of MDs – Second Survey Deadline Extended The deadline for the second survey for data collection from manufacturers and other economic operators in the framework of the “Study supporting the monitoring of availability of medical devices on the EU market” has been extended. The deadline is now 21 March 2025. Study on Availability of MDs – Second Survey Deadline Extended
Regulatory Innovation Office Chair Lord Willetts has been appointed as Chair of the Regulatory Innovation Office (RIO). Regulatory Innovation Office Chair
New Chief Executive Appointed at MHRA Lawrence Tallon has been appointed as the new Chief Executive Officer of MHRA, succeeding Dame June Raine DBE who is retiring. He will begin the role from 1 April 2025. New Chief Executive Appointed at MHRA
Regulation on the European Health Data Space Published The Regulation on the European Health Data Space (EHDS) has been published in the Official Journal of the EU. Regulation on the European Health Data Space Published
New Chair of NHS England Dr Penelope Dash has been appointed by the government as the next chair of NHS England. New Chair of NHS England
Planned Meetings of MDCG and Subgroups in 2025 Updated The European Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. Planned Meetings of MDCG and Subgroups in 2025 Updated
PAGB Food Supplements Regulatory Workshop The next PAGB Food Supplements Regulatory workshop will take place at the PAGB offices on Tuesday, 18 March, from 10:00 AM to 4:00 PM. PAGB Food Supplements Regulatory Workshop
MHRA Consultation Response on Proposed Changes to Statutory Fees to Support Ongoing Cost Recovery The MHRA has published the government response to the consultation on proposed changes to statutory fees to support ongoing cost recovery. MHRA Consultation Response on Proposed Changes to Statutory Fees to Support Ongoing Cost Recovery
IMDRF Publishes Working Group Briefing Document The IMDRF has published a brief structured by working group, covering background, scope, progress, next steps, EU concerns, and expected decisions. IMDRF Publishes Working Group Briefing Document
MHRA Consultation Response on Future Medical Device Regulations The MHRA has published the first part of the Government’s response to the medical devices regulations consultation, focusing on the retention of four pieces of EU law. MHRA Consultation Response on Future Medical Device Regulations
Defra Guidance on Registering and Paying Fees for Extended Producer Responsibility (EPR) for Packaging Defra has published guidance on EPR registration and fees for organizations responsible under the Extended Producer Responsibility (EPR) for packaging. Defra Guidance on Registering and Paying Fees for Extended Producer Responsibility (EPR) for Packaging
