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Appendix 2 of the ISSCR Guidelines for the Clinical Translation of Stem Cells International, national and local regulations, guidelines and resources A2.1 Codes of Conduct for Research Involving Human Subjects A2.4 Existing International Regulations Governing Good Manufacturing Practice
A2.1. Codes of Conduct for Research Involving Human Subjects Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979). Convention on Human Rights and Biomedicine (Oviedo Convention) (Council of Europe, 1997) European Commission Clinical Trials Directive: 2001/20/EC (2001) European Forum for Good Clinical Practice International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organizations of Medical Sciences, 2002) Nuremburg Code (1947) U. S. Federal Policy for the Protection of Human Subjects, also known as the Common Rule (U.S. Department of Health and Human Services, 2005). World Medical Association Declaration of Helsinki (1964 and updates) A2.2. Existing International Regulations and Regulatory Bodies and Professional Organizations Governing Cell-Based Therapies Regulatory Bodies European Medicines Agency (EMEA) Therapeutic Goods Administration, Australia U.S. Food and Drug Administration (FDA), Center for Biologics and Research FDA listing of international organizations and government agencies Regulations Australia European Union: Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004, also known as the ‘Tissues and Cells Directive’, setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Directive 2006/17/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells Regulation (EC) 1394/2007 of the European Parliament and the Council of the European Union on advanced therapy medicinal products and amending Directive 2001/83/EC List of EU legal documents related to treatments based on tissues and cells. United Kingdom Professional Organizations AABB. Formerly known as the American Association of Blood Banks, AABB includes an Accreditation Program that accredits facilities by activity, in all aspects of blood banking, transfusion medicine, hematopoietic, cellular and gene therapies, and transplantation. Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA). The AHCTA is committed to the harmonization of their respective standards with the objective of creating a single set of quality, safety and professional requirements for cellular therapy including hematopoietic stem cell (HSC) transplantation. AHCTA represents the American Association of Blood Banks (AABB), American Society for Blood & Marrow Transplantation (ASBMT), European Federation for Immunogenetics (EFI), European Group for Blood & Marrow Transplantation (EBMT), Foundation for the Accreditation of Cellular Therapy (FACT), International Society for Cellular Therapy (ISCT) (Europe), Joint Accreditation Committee ISCT-EBMT (JACIE), International NETCORD Foundation, and the World Marrow Donor Association (WMDA). The Foundation for the Accreditation of Cellular Therapy (FACT) is a non-profit corporation co-founded by the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT) for the purposes of voluntary inspection and accreditation in the field of cellular therapy. In 2000, FACT partnered with the NetCord Foundation to develop standards for cord blood collection through release, theNetCord-FACT International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release. In 2006, FACT and JACIE partnered to establish international standards in the field of cellular therapy, the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration. The Joint Accreditation Committee- ISCT and EBMT (JACIE) is a non-profit body established by the International Society for Cellular Therapies (ISCT) and the European Group for Blood and Marrow Transplantation (EBMT) to provide assessment and accreditation in the field of haematopoietic stem cell (HSC) transplantation. Appendix 2.3: Existing International Regulations and Guidelines Governing Procurement of Tissues or Organs for Cell Therapies and Ethical Conduct of Research Involving Humans (See also Appendix 2.2) Guidelines for Clinical Trials Involving Cellular and Tissue-based Products, Israel (Ministry of Health, Pharmaceutical Administration, 2006) Guidelines for the Conduct of Human Embryonic Stem Cell Research, ISSCR (ISSCR Task Force on the Conduct of Human Embryonic Stem Cell Research, 2006) Guidelines for Human Embryonic Stem Cell Research, National Academies (USA) (Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council and Institute of Medicine of the National Academies, 2005 and amendments 2007, 2008) Guidelines for Stem Cell Research and Therapy, India (Department of Biotechnology and Indian Council of Medical Research, 2007) Guidelines for the Use of Human Embryonic Stem Cells for Clinical Application, Japan (Ministry of Health, Labour and Welfare, 2006) National Institutes of Health (USA): Bioethics Resources on the Web National Statement on Ethical Conduct in Human Research, Australia (National Health and Medical Research Council, 2007) Medical Research Council (MRC) Policy on UK Clinical Trials Regulations A2.4 Existing International Regulations Governing Good Manufacturing Practice Australia Australian Code of Good Manufacturing Practice for Medicinal Products Posted December 3, 2008
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