Νομοθεσία

H biogenea pharmaceuticalsΤΜ και το επιστημονικό προσωπικό της ακολουθεί αυστηρά τις απαιτήσεις των σχετικών εθνικών και κοινοτικών διατάξεων. Η Ισχύουσα Νομοθεσία που καλύπτει τις υπηρεσίες συλλογής και κρυοσυντήρησης κυττάρων και ιστών εναρμονίστηκε προς την οδηγία 2004/23/ΕΚ του Ευρωπαϊκού Κοινοβουλίου και του Συμβουλίου της 31.3.2004 για τη θέσπιση προτύπων, ποιότητας και ασφάλειας για τη δωρεά, την προμήθεια, τον έλεγχο, την επεξεργασία, τη συντήρηση, την αποθήκευση και τη διανομή ανθρώπινων ιστών και κυττάρων (EEL102/7.4.2004) και τις συναφείς προς αυτήν οδηγίες 2006/17/ΕΚ (EEL 38/9.2.2006) και 2006/86/ΕΚ (EEL 294/25.10.2006).

Aναφορές

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