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 revising the EU pharmaceutical legislation. The revision provides a much-needed opportunity to ensure better access to pharmaceuticals and plasma-derived therapies for patients in the EU. PPTA has contributed to the European Commission consultations as well as participated in the targeted stakeholder consultation and is looking forward to contributing further to the process.
In its contributions, PPTA calls on the European Commission to consider the following aspects during the revision:
- Plasma-derived medicinal products (PDMPs) are unique therapies and access to these therapies depends on the availability of its starting material – human donated plasma.
- Better alignment of frameworks governing plasma collection and testing (new SoHO Regulation) with other EU frameworks and guidelines regulating manufacturing, quality, and safety of PDMPs.
- Ensure better adapted administrative requirements related to Plasma Master File (PMF).
- Improve standard regulatory processes by ensuring a better harmonisation of regulatory provisions for PDMPs globally.
For more detail, see PPTA position paper on the evaluation of the EU pharmaceutical legislation.
Please click here to access PPTA feedback to the revision of the EU Pharmaceutical legislation Inception Impact Assessment.
- PPTA position paper on Stockpiling: EU needs effective measures to facilitate access to lifesaving medicines made of human plasma (PDMPs)
- PPTA position paper on the revision of the general EU pharmaceutical legislation
- PPTA position paper on the importance of the EU-US MRA for patient access to plasma-derived medicinal products (PDMPs)
- PPTA feedback to the revision of the EU Pharmaceutical legislation Inception Impact Assessment
- PPTA feedback to the EU Pharmaceutical Strategy Inception Impact Assessment
- Roadmap: Revision of the EU general pharmaceuticals legislation
- European Commission: Roadmap on the EU Pharma strategy
- EU Pharmaceutical legislation[Directive 2001/83/EC1) and Regulation (EC) No 726/2004]
- European Commission: Process of the revision of the EU Pharma legislation, Inception Impact Assessment