The Generative Brain

European Directorate for the Quality of Medicines and HealthCare (EDQM), Council of Europe, Blood Guide and transfusion standards

The EDQM is a directorate of the Council of Europe in Strasbourg. It grew out of the 1964 convention that created the European Pharmacopoeia and now also sets standards for blood transfusion, organ, tissue and cell transplantation and other health products. It touches prion disease in two separate ways. For medicines, it runs the European Pharmacopoeia, whose general chapter 5.2.8 on reducing the risk of passing on animal TSE agents matches the EMA note for guidance EMA/410/01 Rev. 3, and it issues certificates of suitability that manufacturers use as the preferred proof that ruminant-derived materials meet that note. For blood, EDQM is the scientific secretariat of the European Committee on Blood Transfusion (CD-P-TS), which maintains the Guide to the preparation, use and quality assurance of blood components, known as the Blood Guide. The 22nd edition came out in May 2025 with revised donor selection criteria on Creutzfeldt-Jakob disease. The text of that CJD change was not read here; secondary sources from Spain say it keeps permanent deferral for family risk, dura mater and corneal grafts and pituitary extract treatment, and drops deferral for UK stays and for transfusion received in BSE or vCJD countries. Its legal weight is set to grow: under Regulation (EU) 2024/1938, which applies from 7 August 2027, following ECDC or EDQM technical guidelines is treated as meeting the regulation's standards, with ECDC covering communicable disease transmission and EDQM covering other protection. Information only, not medical, legal or regulatory advice.

Key facts

  • EDQM is a Council of Europe directorate and partial agreement based in Strasbourg, tracing back to the 1964 Convention on the Elaboration of a European Pharmacopoeia (ETS 50); it took its current name in 2007 after being the European Pharmacopoeia secretariat and then the European Directorate for the Quality of Medicines (1996 to 2007).
  • The European Pharmacopoeia has 39 member states and 28 observers, with WHO and the Taiwan FDA also observers; EU pharmaceutical law refers to it directly, according to EMA.
  • EDQM certificates of suitability confirm that a substance meets the relevant Ph. Eur. monograph and can cover the steps taken to reduce the risk of TSE transmission; companies can use them in EMA marketing authorisation applications.
  • The Dutch medicines regulator says applicants must show that ruminant-derived materials at each manufacturing step comply with EMA/410/01 Rev. 3 (Official Journal 2011/C 73/01), preferably through an EDQM certificate of suitability, and that Ph. Eur. general chapter 5.2.8 is identical in content to that note.
  • EMA and the European Commission published a working arrangement with EDQM in April 2019; EDQM also runs the technical secretariat of the Official Medicines Control Laboratories network that retests centrally authorised medicines.
  • Council of Europe blood transfusion work sits under the European Committee on Blood Transfusion (CD-P-TS), for which EDQM has been scientific secretariat since 2007 (search excerpt).
  • The Blood Guide grew out of Council of Europe Recommendation No. R (95) 15. Its 22nd edition (ISBN 978-92-871-9481-7) was prepared over two years by the GTS working group under the CD-P-TS.
  • The 22nd edition was published on 21 May 2025. It reviews all chapters, revises the haemovigilance chapter, adds chapters on components for topical use or injection and on supply emergency planning, and lists Creutzfeldt-Jakob disease first among the changed donor selection criteria, ahead of malaria, blood pressure and pulse, plasmapheresis, iron stores, donor age and insulin.
  • What the 22nd edition says on CJD was not read. A Spanish health ministry document citing it (search excerpt only) keeps permanent deferral for people treated with human pituitary extracts, people with dura mater or corneal grafts and people with a family risk of CJD or another TSE, with listed exceptions. It drops deferral for travel or residence in areas with BSE or vCJD cases and for transfusion received in such areas.
  • The Catalan public blood and tissue bank says people who lived in or travelled to the UK can now give blood, and that its former UK-stay and transfused-abroad exclusions were dropped following EDQM's European recommendations.
  • The EU-level permanent TSE deferral row in Directive 2004/33/EC, Annex III (family risk, corneal or dura mater graft, pituitary-derived medicines) has the same three groups as the criteria the Spanish excerpt says are kept, and leaves variant CJD precautions to national choice.
  • In January 2025 EDQM held an international Blood Conference in Strasbourg with almost 250 participants, co-funded by the European Commission. The conference report, with six EDQM co-authors, calls the Blood Guide one of the formal references in the SoHO Regulation and EDQM a recognised expert body under it.
  • In Regulation (EU) 2024/1938, recital 49 says following ECDC and EDQM guidelines should be an appropriate way to show compliance, and recital 50 says EDQM technical guidelines may be used to implement the standards, including donor eligibility criteria against cancer and other non-communicable diseases.
  • Articles 56(4)(a) and 59(4)(a) of the regulation divide the guideline lanes. For donor and recipient protection, ECDC guidelines cover prevention of communicable disease transmission and EDQM guidelines cover protection other than from communicable disease. Under Article 27(6) inspectors treat the standards as met where a SoHO entity follows these guidelines.
  • Article 82(2) of the regulation deems blood components already checked against the blood component monographs in the EDQM Blood Guide edition shown on the EU SoHO Platform on 7 August 2024 to be authorised SoHO preparations; that date is unconfirmed, since a 26 July 2024 corrigendum, seen only in search excerpts, moves the transitional dates in Articles 81 to 84 to 2027 or later (see regulation-eu-soho-2024-1938).
  • The regulation text read does not mention prions, Creutzfeldt-Jakob disease or TSEs.
  • EDQM has two observers on the ECDC expert panel for SoHO technical guidelines, there to avoid inconsistency with its own guidance.
  • Since 17 June 2025 the EDQM director has been Eugenia Cogliandro, who followed Petra Doerr (from October 2021) and Susanne Keitel (2007 to 2021).

Timeline

  1. 1964Convention on the Elaboration of a European Pharmacopoeia (ETS 50), the origin of EDQM.
  2. 1995Council of Europe Recommendation No. R (95) 15, the basis of the Blood Guide.
  3. 2007EDQM takes on the scientific secretariat for Council of Europe blood transfusion work (search excerpt) and takes its current name.
  4. 2011EMA/410/01 Rev. 3 published in the Official Journal; Ph. Eur. chapter 5.2.8 matches it.
  5. 2019EMA and European Commission working arrangement with EDQM published.
  6. 2024Regulation (EU) 2024/1938 on substances of human origin signed in Brussels.
  7. 2024SoHO Regulation published in the Official Journal; EDQM later named as having observers on the ECDC guideline panel.
  8. 2025Two-day International EDQM Blood Conference opens in Strasbourg.
  9. 202522nd edition of the Blood Guide published, with revised CJD donor selection criteria.
  10. 2025Italian national blood centre announces the 22nd edition.
  11. 2025Eugenia Cogliandro becomes EDQM director.
  12. 2027SoHO Regulation applies; Directives 2002/98/EC and 2004/23/EC repealed.
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