Commission to review pharmaceutical legislation

28/09/2021 28 Views
Commission to review pharmaceutical legislation

On September 27, as part of  the European Health Union, the Commission published a public consultation on the revision of the EU’s pharmaceutical legislation. This is the latest step towards an ambitious reform as announced in the Pharmaceutical Strategy for Europeadopted in November 2020. The consultation will be open until December 21.

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 with stakeholders’ organisations.

A major flagship action is the revision of the general pharmaceutical legislation, foreseen for end 2022, which is also being supported by an ongoing study. Other flagship actions of the Strategy focus on Health Technology Assessment, EU Health Data Space, legislation on rare diseases and medicines for children and strengthening the continuity and security of supply of medicines in the EU.

This public consultation launched today notably addresses:

  • The performance of the EU’s pharmaceutical legislation;
  • Unmet medical needs;
  • Incentives for innovation;
  • Antimicrobial resistance;
  • Future-proofing the regulatory framework for novel products;
  • Improved access to medicines;
  • Competitiveness of the European markets to ensure affordable medicines;
  • Repurposing of medicines;
  • Security of supply of medicines;
  • Quality and manufacturing of medicines;
  • Environmental challenges.

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