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EFPIA calls for the revision of the EU Variation Framework

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Published on: 17 March 2023

Published by LNB News

LNB News 17/03/2023

Document Information

Issue Date: 17 March 2023

Published Date: 17 March 2023

Jurisdiction(s): European Union

Article summary

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released an article on how a modernised EU Variation Framework will improve the life of European patients. The article noted that the EU Variation Regulation (1234/2008) and Classification Guideline (C(2013) 2804) was outdated and rigid and in need of modernisation to support future innovation in medicine development and manufacturing and to address the challenges with medicines associated with devices, such as, as cell- and gene/ advanced therapies (ATMPs). The EFPIA made further recommendations going forward with the revision of the EU Variation Framework and concluded that the revision is urgent and should be tackled as soon as possible.

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