Legislation

References

I. USA

FDA
http://www.fda.gov/default.htm
FDA/CBER

１）Tissue Rules

・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%20
the%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

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