§ Mr. BellinghamTo ask the Secretary of State for Health what assessment he has made of the impact of the EU Clinical Trials Directive in the UK. [185535]
§ Ms Rosie WintertonThe United Kingdom Clinical Trials Regulations1 to implement the Clinical Trials Directive2 came into force on 1 May 2004. It is still early to fully assess the impact of the Directive in the UK. Transitional arrangements allowed holders of existing authorisations or exemptions to roll them over as clinical trial authorisations without applying again to the Medicines and Healthcare products Regulatory Agency (MHRA) or paying a fee. The MHRA has met its deadline of 14 days for Phase I applications and of 30 days for all other applications. Generally the new procedures have been introduced without disruption of clinical trials. Industry and academia have both given early positive feedback on the UK's implementation of the Directive.
1 The Medicines for Human Use (Clinical Trials) Regulations 2004 S.I. 1031.2 Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.