European Medicines Agencies Network Data Strategy The European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) have published their European Medicines Agencies Network Data Strategy. This strategy sets out the agreed European medicines regulatory network (EMRN) vision, principles to be followed and goals to be met to maximise the value of the data managed by the EMRN. European Medicines Agencies Network Data Strategy
EDQM – Guidelines on Considerations Issuing Recommendations on Classification of Active Substances as Regards Their Supply The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the new guidelines on the classification of active pharmaceutical substances as regards their supply (prescription and non-prescription status). EDQM – Guidelines on Considerations Issuing Recommendations on Classification of Active Substances as Regards Their Supply
FSA Consultation – Proposed BPA Ban, Alignment With the EU The FSA has launched a public consultation seeking stakeholders’ views on their proposal to implement a ban on the use of bisphenol A (BPA) and other bisphenols in food contact materials (FCMs). The consultation will close on 24 December 2025. FSA Consultation – Proposed BPA Ban, Alignment With the EU
AESGP Webinar – Evaluating Credibility in Digital Campaigns AESGP is hosting a webinar on “Evaluating credibility in digital campaigns: a practical guide and example with Influencer Monitor" on 24 November. AESGP Webinar – Evaluating Credibility in Digital Campaigns
OTC Medicines Pack Design Workshop – Join Us on 6 November The PAGB OTC Medicines Pack Design Workshop is taking place in person at the PAGB office on 6 November from 10am to 4pm. OTC Medicines Pack Design Workshop – Join Us on 6 November
MHRA Medicines Marketing Authorisation: Change of Ownership Form Update MHRA has updated the change of ownership form found in the guidance 'medicines marketing authorisation: change of ownership' which contains information on how to change the ownership from one marketing authorisation (MA) holder to another. MHRA Medicines Marketing Authorisation: Change of Ownership Form Update
European Commission Survey on Draft Guidance on Article 73 AI Act – Incident Reporting The European Commission has launched a targeted stakeholder consultation on the Commission guidance on Article 73 of the AI act which concerns incident reporting (High-Risk AI Systems). European Commission Survey on Draft Guidance on Article 73 AI Act – Incident Reporting
EU AI in Medicine Survey: Stakeholder Priorities to Inform Research and Regulatory Agenda The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) Network Data Steering Group (NDSG) is running a survey to inform research priorities for AI use in the development and evaluation of medicines. EU AI in Medicine Survey: Stakeholder Priorities to Inform Research and Regulatory Agenda
PAGB Align with MHRA Statement Confirming No Link Between Paracetamol Use in Pregnancy and Autism PAGB has aligned with the MHRA's recent statement affirming that there is no evidence linking paracetamol use during pregnancy to autism in children, reinforcing its safety when used appropriately. PAGB Align with MHRA Statement Confirming No Link Between Paracetamol Use in Pregnancy and Autism
CMDh July 2025 Meeting – Minutes The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the minutes from their meeting held on 22-23 July 2025. CMDh July 2025 Meeting – Minutes
EMA Webinar – Revised Environmental Risk Assessment – 1 year experience EMA is hosting a webinar on 'Environmental Risk Assessment' on Monday 6 October from 1.30pm to 4.00pm (GMT). This webinar will cover the one year experience with the revised guideline. EMA Webinar – Revised Environmental Risk Assessment – 1 year experience
CMDh September 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 16-18 September 2025. CMDh September 2025 Meeting – Report
