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ANSM, Agence nationale de securite du medicament et des produits de sante (French medicines and health products safety agency) logo

ANSM, Agence nationale de securite du medicament et des produits de sante (French medicines and health products safety agency)

The ANSM is the French state agency that authorises and monitors health products: medicines, vaccines, biological products such as labile blood products, tissues and cell therapies, and medical devices including in vitro diagnostics. It took over on 1 May 2012 from the AFSSAPS (1999 to 2012), which had itself replaced the Agence du medicament set up in 1993. For prion disease the agency and its predecessor matter in three ways. It set French blood product policy on variant CJD, with the AFSSAPS expert group of late 2000 that preceded the UK stay donor exclusion and plasma leukoreduction. It publishes the standard prion protocol (PSP) and the list of products accepted for inactivating prions on reusable surgical instruments, with a stricter 2018 version due to become the only one in force after 31 December 2026. And it has funded French prion test research, including EFS decontamination work and the INRAE E219K RT-QuIC substrate. Information only, not medical, legal or regulatory advice.

Key facts

  • The ANSM describes itself as the public body that, on behalf of the State, gives access to health products in France and watches their safety across their life cycle, covering medicines, vaccines, biological products and medical devices including in vitro diagnostics, with about 1,000 staff on sites in Saint-Denis, Lyon and Montpellier-Vendargues.
  • The agency was set up on 1 May 2012 under the law of 29 December 2011, replacing the AFSSAPS (created under the law of 1 July 1998), which had replaced the Agence du medicament dating from a law of 4 January 1993; it is a national public administrative body under the health ministry.
  • The French list of labile blood products is fixed by ANSM decision after an opinion from the EFS, and the agency authorises tissues, cell therapy preparations and the establishments that store and distribute them.
  • In a January 2001 notice the AFSSAPS reported its expert group opinion of 11 December 2000: a low theoretical vCJD risk remained for labile blood products after leukoreduction, with a projected 6 to 300 cases in France over 60 years, while the risk from medicines made from French plasma was called extremely low if present and no recall was judged justified.
  • The measures listed in that notice were exclusion of donors with more than one year in the UK between 1980 and 1996, extension of leukoreduction from cellular products (since 1998) to all plasma from April 2001, restricting blood product use to necessary cases, and easier access to recombinant or lower BSE exposure clotting factor products.
  • In October 2004 the AFSSAPS issued a notice on a precautionary recall of lots of LFB plasma-derived medicines, noting that fractionation and nanofiltration (added in 2001) reduce prion risk, and said an expert group would judge individual risk and whether recipients should be informed.
  • The standard prion protocol (PSP) is the reference method manufacturers use to show that a product or process removes or inactivates prions on reusable medical devices; a 2011 health ministry instruction makes it the yardstick next to two reference treatments (sodium hydroxide or concentrated sodium hypochlorite for one hour), and the ANSM publishes the list of compliant products.
  • PSP v2018, published by the ANSM on 15 May 2018, raised the bar to two animal studies (hamster 263K plus a bovine or human strain) and at least three strains in vitro with set sensitivity levels; after an HCSP opinion of 30 October 2023 the older v2011 stays valid until 31 December 2026.
  • As of June 2023 no product compliant with PSP v2018 was on the French market; on 10 June 2026 the ANSM announced the first product entered on the v2018 list, without naming it.
  • ANSM grant P79 PrionMDsecure funded the 2020 EFS study showing that the Surf-PMCA surface test agrees with infectivity in mice and that several commercial reagents fail against vCJD prions, and PrionMDsecure is also listed on the 2021 EFS paper on amplifying sporadic CJD prions.
  • ANSM grant 2014S033 (HAP ANSM 2014/iPDB) is one of three funders listed on the 2025 INRAE paper introducing human PrP E219K as an RT-QuIC substrate.
  • A Europe PMC funding search finds six prion papers mentioning the ANSM, from 2016 to 2025, all from French groups in Montpellier, Jouy-en-Josas, Lyon and Paris; only three carry a structured ANSM grant entry.

Timeline

  1. 1993Law creating the Agence du medicament, earliest predecessor of the ANSM.
  2. 1994France starts specific rules for reprocessing reusable medical devices against prions.
  3. 1998Law providing for the AFSSAPS.
  4. 2000AFSSAPS convenes an expert group on vCJD and blood products; opinion given 11 December 2000.
  5. 2001AFSSAPS notice on vCJD risk from blood products, with UK stay donor exclusion and plasma leukoreduction from April 2001.
  6. 2001Health ministry circular on prion risk in reprocessing medical devices.
  7. 2004AFSSAPS notice on precautionary recall of LFB plasma-derived medicine lots.
  8. 2011Health ministry instruction 2011/449 makes the PSP the method for judging prion inactivation products; PSP v2011 issued by the DGS and ANSM predecessor.
  9. 2012ANSM replaces the AFSSAPS.
  10. 2018ANSM publishes PSP v2018.
  11. 2020ANSM-funded EFS decontamination study published in mSphere.
  12. 2021EFS sporadic CJD PMCA paper published with PrionMDsecure funding.
  13. 2023After the HCSP opinion of 30 October 2023, ANSM keeps PSP v2011 in force until 31 December 2026.
  14. 2025E219K RT-QuIC substrate paper published with an ANSM grant among its funders.
  15. 2026ANSM announces the first product compliant with PSP v2018.
  16. 2026Planned end of PSP v2011 validity.
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