‘Imperfect Compromise’ On EU Pharma Legislation Still Offers Progress

Medicines For Europe Says Latest Parliament Position ‘Accelerates Much Needed Reform’

Reacting to the latest position on the EU pharma legislation overhaul adopted by a European Parliament committee – including changes to previous proposals on regulatory data protection – Medicines for Europe said that the “imperfect” compromise nevertheless offers improvements.

EUROPEAN PARLIAMENT
The ENVI committee made changes to data protection proposals • Source: Shutterstock

Revised proposals for the EU’s overhaul of pharma legislation have been welcomed by off-patent industry organization Medicines for Europe as offering progress, after a European Parliament committee voted to approve a modified version of the European Commission’s “pharmaceutical package.”

Published in April 2023, the package had included significant changes to regulatory data protection (RDP) periods, as well as simplified marketing authorization procedures and moves towards greater digitalization

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