Consultations: EU Good Clinical Practice Directive
Name: EU Good Clinical Practice Directive
Source: European Commission
Date: August 2004
In August this year, the European Commission conducted a consultation on the draft Directive laying down the principles for Good Clinical Practice.
These regulations cover investigational medicinal products for human use and the requirements for authoristation of manufacturing or importation of such products.
This Directive is the third of those designed to regulate and harmonise procedures for conducting clinical trials across Europe, and sits alongside the Directives on Clinical Trials and Good Manufacturing Practice.
This set of Directives were implemented into UK law in May this year in the Medicines for Human Use (Clinical Trials) Regulations.
Downloading PDFs
You will need Adobe's Acrobat Reader to view PDFs. Download it free of charge from the Adobe website or, for people with visual disabilities, visit Access Adobe.
Download our response to this consultation as a pdf, EU Good Clinical Practice Directive
To find out more about our position on the regulation of clinical research in the UK, go to the Science, Research and Technology section of our briefings.
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