As part of its work to establish a forward-looking and crisis-resistant regulatory framework for the pharmaceutical sector, the European Commission published a public consultation on 28 September 2021 on the revision of EU pharmaceutical legislation. This is the last step towards an ambitious reform, as announced in the Pharmaceutical Strategy for Europe adopted in November 2020.

The consultation will run until 21 December and will bring together the views of both the general public and stakeholders in support of the overall assessment and the impact assessment of the revision of EU pharmaceutical legislation. It is a continuation of the public consultation conducted during the preparation of the strategy itself.

Since the adoption of the strategy, the Commission has been working on a number of actions in close cooperation with Member States' authorities, the European Medicines Agency and stakeholder organizations. One of the main leading actions is the revision of the general legislation in the field of pharmaceutical products, scheduled for the end of 2022, which is also supported by an ongoing study. Other flagship actions under the strategy focus on health technology assessment, the EU health data space, legislation on rare diseases and medicines for children, and strengthening the continuity and security of drug supply in the EU.

More information can be found in the document here.

Pharmaceutical products - European legislation
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