The EU Commission has published a public consultation on the revision of the EU’s pharmaceutical legislation.
This is part of its work to create a future-proof and crisis-resilient regulatory framework for the pharmaceutical sector and the latest step towards an ambitious reform as announced in the Pharmaceutical Strategy for Europe, adopted in November 2020.
About this initiative
As part of the EU pharmaceuticals strategy and drawing lessons from the COVID-19 pandemic, the Commission plans to evaluate and revise the EU’s general legislation on medicines for human use to ensure a future-proof and crisis-resistant medicines regulatory system.
What is the aim of the revision of the EUs general legislation on medicines?
The aim of the revision is to:
- ensure access to affordable medicines
- foster innovation, including in areas of unmet medical need
- improve security of supply
- adapt to new scientific and technological developments
- reduce red tape.
What is the aim of the public consultation?
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.
- 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 authorisation procedures, as well as the manufacturing, authorisation and post-authorisation requirements for medicines.
What are the start and end dates of the consultation ?
The consultation will run for twelve weeks between the dates shows below:
Start date: 28 September 2021
End date: 21 December 2021
Where can you find further information on the consultation?
You can find further information on the consultation here.
Where can you respond to the consultation?
You can respond to the consultation here.
Source: Europa website