Frequently Asked Questions for Legislation
[SIZE=4][B]1. What regulations apply to clinical trials within the UK?[/B][/SIZE]
Clinical trials of investigational medicinal products conducted within the UK must be conducted in accordance with The Clinical Trial Regulations.
The Medicine?s for Human Use (Clinical Trials) Regulations, came into force 1 May 2004. The legislation and relevant subsequent amendments to the Regulations can be found at:
[LIST][*] [URL="http://www.legislation.gov.uk/uksi/2008/941/contents/made"]The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 [/URL](external link)[*][URL="http://www.legislation.gov.uk/uksi/2006/2984/contents/made"]The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006[/URL] (external link)[*][URL="http://www.legislation.gov.uk/uksi/2006/1928/contents/made"]The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006[/URL] (external link)[*][URL="http://www.legislation.gov.uk/uksi/2004/1031/contents/made"]The Medicines for Human Use (Clinical Trials) Regulations 2004[/URL] (external link)[/LIST]
This legislation incorporates the European Directive requirements of 2001/20/EC and 2005/28/EC relating to the planning, conduct and Good Clinical Practice requirements expected in all Member States of Europe and the European Economic Area (EEA).
In addition, it is not uncommon for an international trial framework to be made reference to such as the [URL="http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf"]International Committee on Harmonisation (ICH) Guideline E6: Good Clinical Practice [/URL](external link)