Article | December 3, 2024

EU Pharmaceutical Legislation Revisions

Source: ProPharma

By David Crome, Managing Director, Quality & Compliance UK & India

EU Pharma iStock-1285131583

In April 2023, the European Commission proposed a comprehensive reform of the EU pharmaceutical legislation, marking the first major overhaul since 2004. The reform includes a new Directive and Regulation aimed at improving access to affordable medicines, boosting pharmaceutical innovation, and enhancing supply chain resilience. The proposals address unmet medical needs, particularly in antimicrobial resistance (AMR) and rare diseases, while promoting greener, safer medicines and fostering Europe’s competitiveness in the global market. Key features include faster market authorizations through streamlined EMA processes, incentives for broad EU market access, and measures to ensure medicine supply security.

Despite the ambitious goals, the European Federation of Pharmaceutical Industries and Associations has voiced concerns, cautioning that changes to regulatory data protection and incentives could deter innovation and weaken Europe’s pharmaceutical industry. The legislation, slated for discussion after the June 2024 EU elections, aims to balance public health priorities with industry growth, shaping a more sustainable and innovative pharmaceutical landscape in Europe.

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