Bibliography
- Angell M . The ethics of clinical research in the Third World.N. Engl. J. Med.337(12), 847–849 (1997).
Websites
- EMEA website www.emea.europa.eu
- 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. Consolidated version: 30th December 2008 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_83_cons/dir2001_83_cons_20081230_en.pdf (Accessed 10August2009)
- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a EMEA Consolidated version: 20 April 2009 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2004_726_cons/reg_2004_726_cons_en.pdf (Accessed 10August2009)
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, as amended. Consolided version: 30 December 2008 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf (Accessed 10August2009)
- Guidelines on good clinical practice ICH E6 (CPMP/ICH/135/95). Consolidated guideline www.emea.europa.eu/pdfs/human/ich/013595en.pdf (Accessed 10August2009)
- Ethical considerations for clinical trials on medicinal products conducted with the paediatric population http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-10/ethical_considerations.pdf (Accessed 10August2009)
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 26 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, as amended http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf (Accessed 10August2009)
- EMEA strategy paper. Acceptance of clinical trials conducted in third world countries, for evaluation in Marketing Authorisation Applications. Doc. Ref. EMEA/228067/2008, 5 December 2008 www.emea.europa.eu/Inspections/docs/22806708en.pdf (Accessed 10August2009)