Research and development of new medicines
Data integrity, the rights, safety and
well being of the subjects participating in clinical trials are essential. This is stipulated by the World Medical Association in the Declaration of Helsinki (WMA).
To assure the above, clinical research must be conducted in compliance with Good Clinical Practice (GCP). Investigational Products (IPs) must be manufactured, handled and distributed in compliance with Good Manufacturing Practice (GMP).
The internationally recognised standard for GCP is the ICH-GCP that has been developed in 1996 with contribution from regulators and industry representatives for Europe, US and Japan (see ICH).
Many countries have inspection programs to monitor and assess compliance with GCP and GMP. Marketing authorisations are also regulated.
The regulatory framework in Europe is based on the Clinical Trial Directive 2001/20/EC and on the Directive 2001/83/EC Annex I as amended by Directive 2003/63/EC. The last directive is for clinical trials included in any marketing authorisation application in the EU. Members States have implemented into law these directories as dictated by the relevant Heads of Medicines Agencies.
For the US market, the regulatory framework is to be found in the FDA regulations 21 CFR parts 11, 50, 54, 56, 312, 314, 601, 812 and 814. (See links: 21 CFR Part 11; 21 CFR Part 50; 21 CFR Part 54; 21 CFR Part 312; 21 CFR Part 56; 21 CFR Part 314; 21 CFR Part 601; 21 CFR Part 812 and 21 CFR Part 814)