Good Clinical Practice Guide
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Thread: Frequently Asked Questions for Legislation

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    Frequently Asked Questions for Legislation

    1. What regulations apply to clinical trials within the UK?

    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:


    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 International Committee on Harmonisation (ICH) Guideline E6: Good Clinical Practice (external link)
    Last edited by MHRA Super Moderator; 25th Oct 2011 at 11:59 AM.

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