The European Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation.
This public consultation aims to collect views of stakeholders and the general public in order to support the evaluation of the existing general pharmaceutical legislation on medicines for human use, and the impact assessment of its revision to ensure a future-proof and crisis-resistant medicines regulatory system.
It builds further on the public consultation conducted for the preparation of the Pharmaceutical Strategy for Europe of November 2020. The general pharmaceutical legislation sets the main definitions, regulatory incentives and authorization procedures, as well as the manufacturing, authorization and post-authorization requirements for medicines.
The consultation will run until 21 December.
A major flagship action of the Strategy 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.