On 26 April 2023 the European Commission has put forth a proposal for a new Directive and new Regulation that will revise and replace the existing general pharmaceutical legislation.
The proposal has been long-awaited and has been created as a
part of the Pharmaceutical Strategy for Europe adopted back in
2020.
According to the European Commission the intention is to establish
a regulatory framework that:
- Ensures access to affordable medicines for patients, and addressing unmet medical needs
- Supports competitiveness, innovation and sustainability of the EU's pharmaceutical industry and the development of high quality, safe, effective and greener medicines
- Enhance crisis preparedness and response mechanisms, diversified and secure supply chains, addressing medicines shortages, and
- Ensures a strong EU voice in the world, by promoting a high level of quality, efficacy and safety standards
Want to know more?
Plesner has a dedicated Life Science team specifically focusing on
examining the new proposal and closely following its development.
If you are interested in sparring and/or a brief introduction to
the new proposal don't hesitate to reach out.
For further information see the Commission's website
Read the new proposed Regulation
Read the new proposed Directive
Originally published 27 April 2023
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