On 26 April 2023, the European Commission presented a proposal to overhaul pharmaceutical legislation , aiming to update a regulatory framework that had not been substantially changed in over twenty years. This reform, an integral part of the Pharmaceutical Strategy for Europe , aims to ensure that citizens have access to safe, effective, and affordable medicines, while strengthening the competitiveness of the sector.
The key objectives of the reform are four:
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Greater access to medicines : faster authorisation times and incentives to promote the availability of medicines in all Member States.
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Stimulating innovation : specific measures to support research and development, particularly for orphan and paediatric drugs.
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Tackling shortages and securing supply chains : New monitoring and transparency rules to prevent supply disruptions.
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Regulatory simplification : reducing bureaucracy and streamlining regulatory processes for pharmaceutical companies.
For companies in the sector, the impact will be significant. Once approved, the reform will introduce new rules for marketing authorizations and regulatory changes , as well as targeted incentives for the development of innovative therapies. Companies will therefore need to prepare to adapt internal processes and development strategies, with particular attention to documentation management and compliance.
In 2025, the legislative process is still ongoing: the European Parliament and the Council of the EU are discussing amendments, but it is clear that the reform represents a turning point for the European pharmaceutical industry. Companies will need to carefully monitor regulatory developments to be ready to implement the changes as soon as they come into force.
For a detailed analysis of the reform and its practical implications, discover our guides to EU pharmaceutical regulations.
