The Generative Brain

Paul-Ehrlich-Institut (German federal institute for vaccines and biomedicines, competent authority for blood products)

The Paul-Ehrlich-Institut (PEI) in Langen, Hesse, is a senior federal authority under the German Federal Ministry of Health that authorises and controls biomedicines, including vaccines, sera and blood products. It traces back to a serum testing institute founded in Berlin in 1896 and has been an independent federal authority since 1972. For prion disease its role is regulatory: as the competent authority for blood and blood products it set the German precautions against variant CJD in blood and plasma, starting with a 1998 ban on UK plasma for plasma products, an order for leucodepletion from October 2001, donor exclusion for long UK stays and a 2005 order excluding donors who had surgery or a transfusion in the UK after 1979. After the Arbeitskreis Blut reassessed vCJD risk in statement S 27 (December 2024), the PEI revoked its 2005 order in May 2025. It co-runs a yearly workshop with IPFA on blood-borne pathogens that has included vCJD sessions. Information only, not medical, legal or regulatory advice.

Key facts

  • The PEI is a senior federal authority reporting to the Federal Ministry of Health, based in Langen near Frankfurt am Main, with roughly 900 staff; its tasks include marketing authorisation of biomedicines, clinical trial authorisation, pharmacovigilance, official batch control and inspections.
  • The institute was founded in 1896 in Steglitz near Berlin as an institute for serum research and testing under Paul Ehrlich, became an independent senior federal authority in 1972 and moved to Langen from 1987, with the new building opened in 1990.
  • In 2000 the PEI described itself as the German competent authority for blood and blood products: each marketing authorisation fixes which collection centres and countries of origin are allowed, it had not accepted and would not accept UK blood or plasma collection centres, and it checks this through state release of every plasma product batch.
  • In spring 1998 the PEI used its batch control powers to stop UK plasma being used to make plasma products in Germany. In 2000 it still judged that excluding all donors with UK stays in 1980 to 1996 would cause shortages.
  • A PEI order of 18 August 2000, issued in a graded risk procedure (Stufenplanverfahren), required leucodepletion of cellular blood products from 1 October 2001, and since October 2001 donors who spent six months or more in Great Britain between 1980 and 1996 have not been accepted in Germany. Trade press in April 2001 also listed recall of blood products when a donor is found to have vCJD among the PEI precautions.
  • In 2001 the Federal Health Minister asked the PEI president and the head of the RKI blood working group to draft a national blood supply strategy for vCJD; it called for funding of donor screening tests, strict indications for transfusion and, until a test existed, exclusion of transfused donors (about 4 percent of donors), while rating plasma products such as factor VIII and albumin as very unlikely carriers. PEI staff also sat on the follow-up working group whose report the Arbeitskreis Blut published in 2006.
  • By an order of 4 April 2005 (Bundesanzeiger 85, 7 May 2005) the PEI barred, from 1 May 2005, use of donations from anyone who had surgery or a transfusion in the United Kingdom on or after 1 January 1980, covering whole blood, cellular components and plasma for transfusion, and required a vCJD warning in product information; legal basis was section 28 of the German Medicines Act.
  • On 28 May 2025 the PEI published the revocation of the 2005 order, both the donor exclusion and the warning text (file dated 16 May 2025). A search excerpt of the decision PDF ties the revocation to the Arbeitskreis Blut S 27 reassessment (excerpt only).
  • Since 1994 the PEI has run an annual International Workshop on Surveillance and Screening of Blood-borne Pathogens with IPFA; the 28th edition (Porto, September 2022) listed vCJD and other prion diseases as a topic.
  • A PEI expert sits as a co-opted member on the EMA Committee for Medicinal Products for Human Use (re-elected November 2023, term to November 2026), and the PEI releases batches of blood products nationally and as an official European control laboratory.

Timeline

  1. 1896founded in Steglitz near Berlin as an institute for serum research and testing.
  2. 1972becomes an independent senior federal authority.
  3. 1994first IPFA/PEI workshop on surveillance and screening of blood-borne pathogens.
  4. 1998(spring): PEI stops use of UK plasma for plasma products in Germany.
  5. 2000PEI order requiring leucodepletion of cellular blood products from 1 October 2001.
  6. 2001joint PEI and RKI national blood supply strategy on vCJD; from October 2001 donors with six months or more in Great Britain in 1980 to 1996 not accepted.
  7. 2005order excluding donors with UK surgery or transfusion since 1980 and requiring a vCJD warning, effective 1 May 2005.
  8. 202228th IPFA/PEI workshop in Porto with vCJD and other prion diseases on the programme.
  9. 2023PEI expert re-elected co-opted member of the EMA CHMP.
  10. 2025PEI revokes the 2005 vCJD order (published 28 May 2025).
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