Plasma in the revised EU pharmaceutical legislation

PPTA’s views on strengthening upcoming EU pharmaceutical legislation

As part of the launch of the Pharmaceutical Strategy for Europe, the European Commission is currently revising the EU pharmaceutical legislation. PPTA is tracking the process and its members are providing input to the Commission’s Inception Impact Assessment and to the public consultation.

In its initial feedback, PPTA is focusing on the following four areas of the pharmaceutical legislation where plasma needs to be recognized:

  • The need to clearly define “access to medicines” and “unmet needs” for plasma-derived medicines.
  • Innovation — including enhancing existing incentives for manufacturers.
  • "Supply" and sustainability — specifically that insufficient EU plasma donations lead to insufficient biological starting material for producing plasma-derived medicines for patients across the EU.
  • The need to simplify and improve complex regulatory processes and for global convergence with other relevant jurisdictions.

Please click here to access PPTA feedback to the revision of the EU Pharmaceutical legislation Inception Impact Assessment.

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