Guidelines and rules of the cell-based therapy in USA, UK, and Europe

Link for the guidelines or rules of the cell-based therapy in USA, UK, and Europe.
This is written by Mr Yuji Yamamoto, JST, Japan. This is an excellent list for scientists, businessmen, and physicians in the field of regenerative medicine/cell-based therapy.

I. USA

FDA:
http://www.fda.gov/default.htm
FDA/CBER http://www.fda.gov/cber/index.html
FDA Cellular & Gene Therapy Publications
http://www.fda.gov/cber/genetherapy/gtpubs.htm

１）Tissue Rules
・Title 21 Code of Federal Regulations / Sec 1271 (21CFR 1271) http://www.access.gpo.gov/nara/cfr/waisidx_07/21cfr1271_07.html
・Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products - 8/8/2007
http://www.fda.gov/cber/gdlns/tissdonor.htm

２）Cellular & Gene Therapy Rules
・Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 4/9/2008
http://www.fda.gov/cber/gdlns/cmcsomcell.htm
・Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) - 4/9/2008
http://www.fda.gov/cber/gdlns/gtindcmc.htm

３）How to approach to cell-based therapy
・Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals ﾐ 7/12/1993
http://www.fda.gov/cber/gdlns/ptccell.pdf
・Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice - 10/14/1993
http://www.fda.gov/cber/genadmin/fr101493.pdf
・Proposed Approach to Regulation of Cellular and Tissue-Based Products - 2/28/1997
http://www.fda.gov/cber/gdlns/celltissue.pdf
・Reinventing the Regulation of Human Tissue
http://www.fda.gov/cber/tissue/rego.htm
http://www.fda.gov/cber/tissue/regotab.pdf (Table)


II. Europe

EMEA http://www.emea.europa.eu/
EMEA / Committee for Medicinal Products for Human Use (CHMP)
http://www.emea.europa.eu/htms/general/contacts/CHMP/CHMP.html
EudraLex / The Rules Governing Medicinal Products in the European Union
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm

1) Tissue Rule
・ The tissues and cells directive　(2004/23/EC)
http://www.who.int/ethics/en/ETH_EU_Directive_2004_23_EC.pdf

2) GCP Rules
・ The clinical trials directive (2001/20/EC、2005/28/EC)
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2005_28/dir_2005_28_en.pdf

3) Authorization Rules
・ the medicinal products directive (2001/83/EC, 2003/63/EC)
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_83/dir_2001_83_en.pdf
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2003_63/dir_2003_63_en.pdf
・ the medical devices directive (93/42/EEC)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML
・ Regulation on Advanced therapy medicinal products (Regulation (EC) No 726/2004)
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf

4) GMP Rules
・GMP directives (2003/94/EC)
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdf
・EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm

5) Guideline on human cell-based medicinal products (EMEA/CHMP)
http://www.emea.europa.eu/pdfs/human/cpwp/41086906en.pdf

6) Pharmacovigilance Rules
・EudraLex Volume 9A（Pharmacovigilance for medicinal products for Human use）
http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-9/pdf/vol9_2007-07_upd07.pdf


III. UK

MHRA http://www.mhra.gov.uk/index.htm
HTA (Human Tissue Authority) http://www.hta.gov.uk/
HFEA (Human Fertilisation & Embryology Authority) http://www.hfea.gov.uk/
National Institute for Biological Standards and Control http://www.nibsc.ac.uk/
UK Stem cell Bank http://www.ukstemcellbank.org.uk/

1) Tissue Rules
・the Human Tissue Act (2004)
http://www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1

2) ES cells Rules
・The Human Fertilisation and Embryology (HFE) Act (1990)
http://www.opsi.gov.uk/acts/acts1990/Ukpga_19900037_en_1.htm
・Code of practice for the use of human stem cell lines (UK stem cell Bank, 2005)
http://www.ukstemcellbank.org.uk/documents/Code%20of%20Practice%20for%20the%20Use%20of%20Human%20Stem%20Cell%20Lines.pdf

3) GCP Rules
・UK Statutory Instrument 2004 No.1031(The Medicines for human use clinical trials regulations)
http://www.opsi.gov.uk/si/si2004/20041031.htm

4) GMP Rules
・The Code of Practice for the Production of Human-derived Therapeutic Products (MHRA, 2002)
http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON007432&RevisionSelectionMethod=LatestReleased

Thanks, Yuji.