Current regulations for the production of multipotent mesenchymal stromal cells for clinical application

Transfusion Medicine and Hemotherapy

Volumn 35, Issue 4, 2008, Pages 295-298

  Slaper Cortenbach, Ineke C M ^a  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

Author keywords

Advanced therapy medicinal products; MSC; Regulatory issues

Indexed keywords

CELL THERAPY; CLINICAL TRIAL; EUROPE; GRAFT VERSUS HOST REACTION; HOSPITAL; HUMAN; LAW; MESENCHYME CELL; MULTICENTER STUDY; NONHUMAN; REVIEW; SAFETY; STROMA CELL;

EID: 58549108431     PISSN: 16603796     EISSN: None     Source Type: Journal    
DOI: 10.1159/000144043     Document Type: Review

References (16)

1. Horwitz EM, Le Blanc K, Dominici M, Müller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A: Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy 2005;7(5):393-395.
2. Easy access to the published documents (L stands for Legislation) in the Official Journal (OJ) of the European Union: http://eur-lex.europa.eu/en/ index.htm.
3. Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Reg (EC) No 726/2004 OJ L 324, 10-12-2007, pp 121-137.
4. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards on quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of tissues and cells. OJ L 102, 07-04-2004, pp 48-58.
5. Commission Directive 2006/17/EC of 8 February 2006 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 tissues and cells. OJ L 38, 09-02-2006, pp 40-52.
6. Commission Directive 2006/86/EC of 24 October 2006 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 coding, processing, preservation, storage and distribution of tissues and cells. OJ L 294, 25-10-2006, pp 32-50.
7. Ashford P, Distler P, Gee A, Lankester A, Larsson S, Feller I, Loper K, Pamphilon D, Poston L, Rabe F, Slaper-Cortenbach I, Szczepiorkowski Z, Warkentin P: Standards for the terminology and labeling of cellular therapy products. Transfusion 2007 47(7):1319-1327.
8. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the law, regulations and administrative provisions of the MS relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. OJ L121, 01-05-2001, pp 34-44.
9. Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufaturing practice in respect of medicinal products for human use and investigational medicinal products for human use. OJ L 262 14-10-2003, pp 22-26.
10. GMP guidelines: http://ec.europa.eu/enterprise/pharmaceuticals/ eudralex/vol4-en.htm.
11. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311, 28-11-2001, pp 67-128.
12. ISCT European LRA Committee: www.celltherapysociety.org/Committees- Working-Groups/Committees/Regulatory-Affairs-Europe.aspx.
13. EU DG Sanco: Quality and Safety of tissues and cells: http://ec.europa.eu/health/ph-threats/human-substance/tissues-en.htm.
14. EU DG Enterprise and Industry: Advanced Therapies: http://ec.europa. eu/enterprise/pharmaceuticals/advtherapies/advanced-en.htm.
15. EMEA: www.emea.europa.eu.
16. ISBT 128 Labelling: www.ICCBBA.org.