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