Date
Location
EMA is hosting the fourteenth industry stakeholder platform on the operation of the centralised procedure for human medicines on 23 June 2025. This will be the fourteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations, aiming to foster a constructive exchange on general updates and more focused discussions on specific processes and issues to support continuous improvement. This meeting will focus on the implementation of the variation regulation and guideline; along with ongoing initiatives concerning the centralised procedure. We will also provide updates on the on the focus group on predictability and the revamp AR process, as well as ongoing and future pilots; including the ICMRA collaborative assessment and hybrid inspection pilots. Additionally, we will discuss the implementation of IRIS system for lifecycle management of medicinal products. Furthermore, information and discussion will be held on streamlining regulatory processes; addressing regulatory challenges for biological medicinal products for human use; combination products; and follow-up on the clinical study data pilot.