Deadline to Submit pEPR Data Obligated businesses must submit 2024 packaging data by 1 April 2025 under new extended producer responsibility for packaging (pEPR) scheme Deadline to Submit pEPR Data
MHRA Updates Category 1 and 2 Lists Following Windsor Framework Implementation The MHRA has updated the category lists following the implementation of the Windsor Framework. MHRA Updates Category 1 and 2 Lists Following Windsor Framework Implementation
Updated MHRA Guidance on Supplying Authorised Medicines to Northern Ireland The MHRA has updated the guidance on supplying authorised medicines to Northern Ireland. Updated MHRA Guidance on Supplying Authorised Medicines to Northern Ireland
NHS to be Merged Back Into DHSC As part of the Prime Minister’s speech on civil service reform, he has announced that NHS England will be merged back into Department of Health and Social Care (DHSC). NHS to be Merged Back Into DHSC
New Approach to Ensure Regulators and Regulation Support Growth The Chancellor met with 8 regulators as part of the Governments 'war on red tape' and has launched an Action Plan to reduce the regulatory burden on businesses by 25%, streamline regulatory processes, and drive economic growth. The group of regulators included MHRA. New Approach to Ensure Regulators and Regulation Support Growth
Joint Stakeholder Engagement Forums: 2025 Dates and Participation Details Defra has announced all upcoming dates for the Joint Stakeholder Engagement Forums for 2025. Joint Stakeholder Engagement Forums: 2025 Dates and Participation Details
EMA Management Board – March 2025 Meeting Highlights EMA has published the highlights of the EMA Management Board meeting that took place on 14 March 2025. EMA Management Board – March 2025 Meeting Highlights
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