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Regulations & Guidelines

Click below to discover how JACIE accreditation and/or related Standards are cited in the following countries and international bodies.



Engagement with JACIE a requirement for allogeneic transplant centres according to Arrêté du 3 avril 2009 relatif au contenu du document d’évaluation des activités de greffes d’organes et de greffes de cellules hématopoïétiques.


JACIE accreditation will be a legal requirement for transplantation centers (doing autologous and/or allogeneic transplantations) in Belgium for reimbursement by the social security according to C-2012/22474 Arrêté royal modifiant l'article 20, § 1er, a), de l'annexe à l'arrêté royal du 14 septembre 1984 published 21-12-2012.


Ordinance Pravilnik o uvjetima u pogledu prostora, stručnih radnika, medicinsko-tehničke opreme i sustava kvalitete za obavljanje djelatnosti prikupljanja, uzimanja, testiranja, obrade, očuvanja, pohrane i raspodjele ljudskih tkiva i stanicahaematopoietic. Art 35 (2) "progenitor cells bank must be accredited according to the JACIE standards" published 17-06-2013


Accreditation required to receive reimbursement from Social Insurance for treatments. Ordonnance du DFI sur les prestations dans l’assurance obligatoire des soins en cas de maladie (Ordonnance sur les prestations de l’assurance des soins, OPAS


Decreto Legislativo 25 gennaio 2010, n.16 implementing the European Directives on Tissues and Cells cites a 2003 agreement recognising JACIE

The Netherlands

Accreditation required to receive authorisation to transplant from Ministry of Health

United Kingdom

JACIE is a requirement according to NHS Commissioning Board: Clinical Commissioning Policy: Haematopoietic Stem Cell Transplantation (HSCT) (All Ages) (April 2013) Reference: NHSCB/B04/P/a



Reference to FACT-JACIE standards by The National Pathology Accreditation Advisory Council (NPAAC) in Requirements for Procedures Related to the Collection, Processing, Storage and Issue of Human, Haemopoietic Progenitor Cells, Fourth edition 2013


Piano Oncologico Nazionale 2010-2012 cites JACIE accreditation

United Kingdom

JACIE cited in National Institute for Health and Clinical Excellence (NICE) guidelines 

The Future of Unrelated Donor Stem Cell Transplantation in the UK. A Report from the UK Stem Cell Strategic Forum (July 2010). NHSBT

JACIE cited in Specialised Services National Definitions Set (3rd edition) SSNDS Definition No.2, Specialised Services for Blood and Marrow Transplantation (all ages)

Welsh Health Specialised Services (WHSSC) Blood and  Marrow Transplantation Commissioning Policy

Related information

In January 2012, JACIE began compiling information on regulatory issues affecting transplant programmes that also impact on the JACIE inspection. The aim of the survey is to collect basic information on the different national regulations relevant to the JACIE Standards. With the results of the survey, we are able to provide inspectors with a list of items that they should expect to see during the inspection. This is especially relevant for when an inspector goes to visit a centre in another country and is unfamiliar with local regulations.  

The following countries have reported information: Austria, Finland, Germany, Hungary, Italy, Slovakia, Sweden, Turkey, United Kingdom.