Resources and Links
Some useful links to sites and information of interest.
Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency (EMEA)
US Food and Drug Administration (FDA)
National Research Ethics Service (NRES)
Royal College of Nursing (RCN)
The Institute of Clinical Research (ICR)
Declaration of Helsinki
International Conference on Harmonisation Good Clinical Practice Guidelines
European Union Clinical Trial Directive
European Union Good Clinical Practice Directive
The Medicines for Human Use (Clinical Trials) Regulations 2004 (Statutory Instrument 2004 No. 1031)
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (Statutory Instrument 2006 No. 1928)
The Active Implantable Medical Devices Directive 90/385/EEC imp 1/1/95 (AIMDD)
Clinical Trials Toolkit
Medical Devices Directive 93/42/EEC imp 13/6/98 (MDD)
In Vitro Diagnostic Medical Devices Directive 98/79/EEC imp 7/6/00 trans 7/12/03 (IVDMDD)
Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.
