1. European Commission Directive 2001/20/EC. Clinical trial directive. 2004 May. Brussels, Belgium. Available from:
2. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
E6: Good Clinical Practice. Geneva, Switzerland. Available from:
3. European Commission. Directive 2003/94/EC, Laying down the Principles and guidelines of good manufacturing practice in
respect of medicinal products for human use and investigational products for human use. Brussels, Belgium. Available from:
4. European Commission. EUDRALEX, Vol. 4, Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice. Annex
13, Revision 1. Brussels. 2003 July. Manufacture of investigational medicinal products, Available from: pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/anx13en030303Rev1.pdf
5. US Food and Drug Administation, Rockville, MD. Pharmaceutical cGMPs for the 21st century—A risk-based approach. Press
Release, Aug. 21, 2002, Available from:
http://www.fda.gov/oc/guidance/gmp.html and Final report, Fall 2004. Available from:
6. FDA. Guidance for industry. Q8. Pharmaceutical development, Available from:
7. FDA. Guidance for industry. PAT—A framework for innovative pharmaceutical development, manufacturing, and quality assurance.
8. FDA. Guidance for industry. INDs—Approaches to complying with CGMP during Phase 1. Available from:
9. FDA. ONDC's new risk-based pharmaceutical quality assessment system. 2004 September 29. Available from:
10. European Commission. Enterprise and Industry. Rules governing medicinal products in the European Union, Volume 4, Good
manufacturing practices for medicinal products for human and veterinary use. Available from:
11. FDA. CDER. Guideline on the preparation of investigational new drug products (human and animal). 1991 March. Available
12. European Commission. Volume 4. Good manufacturing practices. Annex 16. Certification by a qualified person and batch
release. 2001 July. Available from: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm
13. FDA. CDER. Content and format of investigational new drug applications (INDs) for Phase 1 studies of drugs, including
well-characterized, therapeutic, biotechnology-derived products, 1995 November. Available from:
14. Medicines and Healthcare products Regulatory Agency.
15. French Health Products Safety Agency,
16. FDA. Guidance for industry Q9 quality risk management Available from:
17. FDA. Guidance for industry. Quality systems approach to pharmaceutical current good manufacturing practice regulations.
2004 September. Available from:
18. Federal Register September 19, 2005. Submission of chemistry, manufacturing, and controls information in a new drug application
under the new pharmaceutical quality assessment system; Extension of application and comment deadlines. Available from: