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
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.