DHSC Consultation: Proposed Amendments to the Statutory Scheme for Branded Medicines Pricing The Department of Health and Social Care (DHSC) has launched a consultation on proposed changes to the statutory scheme for branded medicines pricing. DHSC Consultation: Proposed Amendments to the Statutory Scheme for Branded Medicines Pricing
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
EMA Consultation – Reflection Paper on Regulatory Testing Requirements for Medicinal Products & Opportunities for Implementation of 3Rs The draft EMA reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs (replacement, reduction, refinement) has been published for consultation. In addition, the 3Rs Working Party is holding a plenary meeting to showcase the Agency's commitment to ensuring the implementation of 3Rs principles in the development and evaluation of medicinal products. EMA Consultation – Reflection Paper on Regulatory Testing Requirements for Medicinal Products & Opportunities for Implementation of 3Rs
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
MHRA Marketing Authorisations Granted 15 to 28 February MHRA granted 9 OTC licences during 15 to 28 February 2025. MHRA Marketing Authorisations Granted 15 to 28 February
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
OTC Medicines Pack Design – Get It Right First Time! Join Us on 3 April The PAGB OTC Medicines Pack Design Workshop is taking place online on 3 April from 10am to 4pm. OTC Medicines Pack Design – Get It Right First Time! Join Us on 3 April
AESGP Webinar – Environmental Risk Assessment AESGP is hosting a webinar on 'Environmental Risk Assessment' on Monday 10 March from 11.30am to 1.00pm (GMT) The webinar will provide a general overview of the environmental risk assessment looking at its scope and main objectives. AESGP Webinar – Environmental Risk Assessment
