Meeting on8 June2026 10:30am to 1:30pm ROOM F101000/MED2 EU-Directorate General for Health and Food Safety-101 rue Froissart,Brussels AGENDA 1.Introduction by the Co-Chairs and presentation of the participants 2.Adoption of the agenda3.Exchange on trends in the evolution of the EU and the UK regulatory frameworks formedicinal productsa.EUpresentation of the Biotech Act, an update on the EU’s Critical MedicinesAct,the EU pharmaceutical legislation reformand theEU GoodPharmacovigilance Practice guidanceb.Update by UK on the implementation of the point of care framework,presentations onclinicaltrials reform, therapies for rare diseases andsubscription model for antimicrobials4.Update on implementation of Annex 12 with respect to recognition of inspectionsand exchange of official GMP documents5.Conclusions