Medicines for Human Use: Draft Regulations on Clinical Trials

House of Lords written question – answered on 26th June 2003.

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Photo of Baroness Hayman Baroness Hayman Labour

asked Her Majesty's Government:

What were the main concerns expressed by the charitable and public sector in relation to the committee on the draft Medicine for Human Use (Clinical Trials) Regulation 2003; and what steps are being taken to address these concerns.

Photo of Lord Warner Lord Warner Parliamentary Under-Secretary, Department of Health, Parliamentary Under-Secretary (Department of Health)

The draft regulations are to transpose into United Kingdom law Directive 2001/20/EC on approximation of the laws, regulations and administrative provisions of the member states relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Consultation on the draft regulations closed on 16 May. The Medical Research Council's response is available in full on its website. Its assessment reflected the main concerns expressed by the charitable and public sector.

The Department of Health and the MRC have agreed jointly to lead a project to clarify the arrangements for publicly funded clinical trials involving medicines in the UK. It will draw up practical advice to enable publicly funded clinical trials involving medicines to comply with the law while making best use of existing good practice, minimising additional bureaucracy and making maximum use of public resources to avoid unnecessary expense.

The project is about to start, under the chairmanship of Professor Kent Woods, Director of the NHS Health Technology Assessment Programme. It will draw extensively on expert advice from trialists and from the charitable and public sector.

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