MHRA – Scientific Advice Update MHRA has announced from 21 January 2025, they will review all new requests for scientific advice meetings against whether the requirements can be addressed with existing guidance, written advice or a scientific advice meeting. This means for a temporary period, companies can expect an increased number of requests will be progressed as written-only advice. MHRA – Scientific Advice Update
PAGB Briefing Paper: The Ban of Titanium Dioxide in Foods and Its Implications for Medicines A PAGB briefing paper on titanium dioxide has been uploaded to our website. PAGB Briefing Paper: The Ban of Titanium Dioxide in Foods and Its Implications for Medicines
MHRA – RWE Scientific Dialogue Programme MHRA is launching a pilot Real-World Evidence (RWE) Scientific Dialogue Programme during 2025, designed to help innovators refine their evidence generation strategies while providing clear guidance on regulatory expectations. MHRA – RWE Scientific Dialogue Programme
MHRA – Patient Involvement Strategy: An Assessment of Progress MHRA has published an assessment of progress made in delivering the Patient Involvement Strategy between October 2021 - January 2025. MHRA – Patient Involvement Strategy: An Assessment of Progress
New EU Rules on Health Technology Assessment On 12 January, the Regulation on Health Technology Assessment (HTA) became applicable in the EU. The new rules create an EU framework for the assessment of health technologies, such as medicines and medical devices, by fostering collaboration and coordination between EU Member States. New EU Rules on Health Technology Assessment
MHRA Marketing Authorisations Granted 15 to 31 December MHRA granted 3 OTC licences during 15-31 December 2024. MHRA Marketing Authorisations Granted 15 to 31 December
Transition to IRIS for Post-Authorisation Procedure Management The transition to the IRIS platform for managing post-authorisation procedures has successfully gone live. Transition to IRIS for Post-Authorisation Procedure Management
AESGP Webinar: Navigating the AI Act for Non-Prescription Medicines and Self-Care Medical Device Manufacturers – Challenges and Opportunities Join AESGP's webinar, "Applicability of AI Act for Non-Prescription Medicines and Self-Care Medical Devices Manufacturers: Challenges and Opportunities," on Thursday, 23 January, to explore the implications, challenges, and opportunities of the AI Act for the self-care sector. AESGP Webinar: Navigating the AI Act for Non-Prescription Medicines and Self-Care Medical Device Manufacturers – Challenges and Opportunities
Safety and Security Declarations for Goods Imported from the EU to Great Britain Starting January 2025, Safety and Security declarations will be mandatory for all imports from the EU into GB.. Safety and Security Declarations for Goods Imported from the EU to Great Britain
Supplementary Guidance for Pharmaceutical Wholesalers on the Windsor Framework The MHRA and DHSC have published guidance providing supplementary information for pharmaceutical wholesalers regarding the Windsor Framework. Supplementary Guidance for Pharmaceutical Wholesalers on the Windsor Framework
Defra – pEPR Recyclability Assessment Methodology & Webinar The Extended Producer Responsibility for packaging (pEPR) Recyclability Assessment Methodology (RAM) has been published by Defra and the pEPR Scheme Administrator. Defra is organising a webinar on 16 January 2025 (2-4pm) on the Base Fees and the RAM methodology and approach to reporting. Defra – pEPR Recyclability Assessment Methodology & Webinar
AESGP, EFPIA and Medicines for Europe Position Papers on ePI The Association of the European Self-Care Industry (AESGP), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Medicines for Europe have issued a series of position papers on electronic Product Information (ePI). These aim to advocate for the implementation of ePI and improvement of the patient leaflet content, in the discussions on the Pharmaceutical Legislation Review. AESGP, EFPIA and Medicines for Europe Position Papers on ePI
