Regulatory, Quality and Operations Links

Cellular Therapy Related Societies
AABB
American Society for Blood and Marrow Transplantation
American Society of Hematology (ASH)
American Society for Histocompatibility and Immunogenetics (ASHI)
British Society for Blood and Marrow Transplantation (BSBMT)
European Federation for Immunogenetics (EFI)
International Society for Stem Cell Research (ISSCR)
Tissue Engineering & Regenerative Medicine International Society (TERMIS)
Worldwide Network for Blood & Marrow Transplantation (WBMT)
International Council for Commonality in Blood Banking Automation (ICCBBA)
ICCBBA's ISBT 128 Cellular Therapy Page
ISBT 128 for Cellular Therapy (AABB)

 

Cellular Therapy/Hospital Accreditation Bodies
AABB Standards and Accreditation
ASHI Laboratory Accreditation Programs
College of American Pathologists (CAP)
EFI Laboratory Accreditation Programs

Foundation for the Accreditation of Cellular Therapy (FACT)

Joint Accreditation Committee ISCT EBMT (JACIE)
The Joint Commission

 

Global Regulatory Bodies
Country Governing Body Cell Therapy Specific Website
North America: Canada Health Canada Cell Therapy Specific Website
North America: Mexico COFEPRIS Cell Therapy Specific Website
North America: USA FDA Cell Therapy Specific Website
Europe: Belgium Scientific Institute of Public Health
Europe: EU European Medicines Agency Cell Therapy Specific Website
Europe: France Agence Française de Sécurité Sanitaire des Produits de Santé Cell Therapy Specific Website
Europe: Germany Paul-Ehrlich Institut Cell Therapy Specific Website
Europe: Ireland Irish Medicines Board Cell Therapy Specific Website
Europe: Netherlands Dutch Health Care Inspectorate
Europe: Portugal INFARMED Cell Therapy Specific Website
Europe: Spain Spanish Medicines Agency Cell Therapy Specific Website
Europe: UK Medicines and Healthcare products Regulatory Agency Cell Therapy Specific Website
Oceana: Australia Therapeutic Goods Administration Cell Therapy Specific Website
Oceana: New Zealand Medsafe Cell Therapy Specific Website
Asia: China State Food and Drug Administration Cell Therapy Specific Website
Asia: Hong Kong Drug Office
Asia: India Central Drugs Standard Control Organization Cell Therapy Specific Website
Asia: Japan Ministry of Health, Labour and Welfare
Asia: Malaysia Pharmaceutical Services Division, Ministry of Health
Asia: Philippines FDA
Asia: Sinagapore Health Sciences Authority Cell Therapy Specific Website
Asia: South Korea Korea FDA
Asia: Taiwan FDA
Asia: Thailand FDA
Asia: Vietnam Ministry of Health, Drug Administration of Vietnam
Africa: Egypt NORCB, Egyptian Drug Authority Cell Therapy Specific Website
Africa: South Africa Department of Health, Medicines Control Council
South America: Argentina SENASA Cell Therapy Specific Website
South America: Brazil ANVISA (Agência Nacional de Vigilância Sanitária)

 

Blood and Marrow Donor and Outcome Registries
Anthony Nolan Marrow Trust
Asia-Pacific Blood and Marrow Transplantation Group (APBMT)
Australian Bone Marrow Donor Registry (ABMDR)
British Society for Blood and Marrow Transplantation (BSBMT) Registry
Bone Marrow Donors Worldwide (BMDW)
Center for International Blood & Marrow Transplant Research (CIBMTR)
Eastern Mediterranean Blood and Marrow Transplantation (EMBMT) Registry
European Group for Blood and Marrow Transplantation (EBMT)
National Marrow Donor Program

 

Useful Regulatory Information
Annual Code of Federal Regulations (CFR)
Centers for Medicare & Medicaid Services (CMS)
FDA Cellular Therapy Biologics Guidance Documents
FDA Center for Biologics Evaluation & Research (CBER)
FDA Registration and Biological Product Deviations
US Food and Drug Administration

 

Other Useful Links
National Marrow Donor Program (MDP) HLA Typing Allele Codes
Production Assistance for Cellular Therapies (PACT)
Social Security Death Index
Small Cell Therapy Laboratory Google Group

 

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