The following organisations and entities cite JACIE accreditation and/or related Standards.
- France 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
- Belgium 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.
- NEW Croatia 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".
- Switzerland 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)
- Italy 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
Guidelines & Standards
- European Directorate for the Quality of Medicines & HealthCare
- Guide to the quality & safety of tissues and cells for human application, 1st edition (2013)
- Guide to the Safety and quality assurance for the transplantation of organs, tissues and cells, 4th edition (2010)
- EU-BIS - European Blood Inspection System
In January 2012, JACIE complied information on regulatory aspects 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:
- United Kingdom
Access the complete survey data here.
Complete the survey here.