Publication of the presentation materials of the Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines held the 23 June 2025
Summary of the event:
EMA was hosting the fourteenth industry stakeholder platform on the operation of the centralised procedure for human medicines on 23 June 2025. This was 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 focused on the implementation of the variation regulation and guideline; along with ongoing initiatives concerning the centralised procedure. We also provided 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 discussed the implementation of IRIS system for lifecycle management of medicinal products. Furthermore, information and discussion were 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.
The presentation materials of the event are now available on the EMA Website.
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vroby (28 juillet 2025). Publication of the presentation materials of the Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines held the 23 June 2025. ELSIBI. Consulté le 16 mars 2026 à l’adresse https://doi.org/10.58079/14fy8





