Extension of EU/US MRA to Include PDMPs Is a Positive Step Forward
Brussels, December 6, 2022: The Plasma Protein Therapeutics Association (PPTA) welcomes the joint EU and US statement, released during the third meeting of the US-EU Trade and Technology Council (TTC). PPTA supports continuous regulatory efforts to implement the provisions of the EU-US Mutual Recognition Agreement (MRA) on GMP inspections and particularly the extension of its scope to include plasma-derived medicinal products (PDMPs).
This represents a significant step towards ensuring more sustainable supply of PDMPs, and will, ultimately, benefit patients who rely on these essential, life-saving medicines (1). It will facilitate global regulatory convergence and reduce regulatory burden for EU and US regulators and the plasma industry, by ending costly and time-consuming, duplicative inspections of PDMP manufacturing facilities, thereby improving patient access to life-saving PDMPs.
In view of the continuing supply chain challenges for PDMPs, which are relied upon by patients with life-threatening, rare diseases and disorders, PPTA asks the EU and US regulators to commit rapidly to a target date for the implementation of the provisions of the agreement.
“This is great news for our industry and for patients. Nevertheless, we see further opportunity to go beyond today’s important commitment, by including plasma donation centres within the scope of transatlantic regulatory cooperation. This would further improve the sustainability of the plasma ecosystem and enable more reliable supply for patients,” commented PPTA’s Executive Director Europe Maarten Van Baelen.
PDMPs can only be made from plasma, which is generously donated by healthy human volunteers (3). Plasma used to manufacture PDMPs is not included in the scope of the original 1998 MRA. If it were given the same consideration as other active pharmaceutical ingredients within the pharmaceutical supply chain, the global supply chain for PMDPs would be further strengthened. Currently, for US plasma to be released for manufacturing in the EU, US donation centres must be inspected by both European and US inspectors. However, there is a limited contingent of EU inspectors who inspect US (and other third country) plasma donation centres. This, as well as interruptions and/or delays to inspections, caused by the COVID-19 pandemic, have further slowed down the production process and directly impacted the availability of plasma for the manufacture of PDMPs for patients.
Maarten Van Baelen added: “The EU is today reliant on the US for 40% of the plasma it needs for manufacturing PDMPs for European patients. And yet, the EU has a solid footprint for manufacturing PDMPs. Significant delays or the inability to import US plasma into the EU, due to low inspection capacity, directly impacts the availability of PDMPs for patients.”
PPTA calls upon EU and US policy makers to support patient access to reliable supply, by further reducing the regulatory burden associated with duplicative plasma centre inspections, which do not bring any benefit to medicinal product quality or safety but negatively impact access to PDMPs (4).
- WHO model list of essential medicines - 22nd list, 2021 World Health Organization (2021) World Health Organization. Available at: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02
- Plasma for fractionation definition: Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (2022) European Commission. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52022PC0338&from=EN
- Source Plasma definition: Code of Federal Regulations (CFR) 21CFR640; TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER F – BIOLOGICS PART 640, ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=640
- The importance of the EU-US MRA for patients access to plasma-derived medicinal products (2022) PPTA position paper. Available at: https://www.euneedsmoreplasma.com/publications-resources
Senior Director, Global Communications