Implementing the European clinical trials directive

摘要

The European Union's clinical trials directive must be implemented in United Kingdom law by May 2004. It is intended to simplify and harmonise the regulation of clinical trials across the European Union, thereby facilitating the internal market in medicinal products while protecting participants and public health. Yet some have expressed concern that it will actually impede and inhibit publicly funded clinical trials, a sector of research in which the United Kingdom has always been strong. What are the contentious issues, and where do matters now stand? The Medicines and Healthcare products Regulatory Agency (MHRA) is the regulatory body responsible for drafting the UK legislation to be laid before parliament early in 2004. In preparation for this the agency consulted widely in February 2003 and provided advice and a helpline via its website (http:// medicines.mhra.gov.uk/ourwork/licensingmeds/ types/clintrialdir.htm). The main concerns elicited were around the role and responsibilities of the spon- sor of the trial, the delay and cost imposed by additional bureaucracy, and new requirements for good clinical practice, pharmacovigilance, and good manufacturing practice standards for investigational medicinal products. A joint project has been set up by the Department of Health and the Medical Research Council to help trialists and the Medicines and Healthcare products Regulatory Agency by documenting current best practice in these areas and to provide advice on systems and approaches that will comply with the law while minimising unnecessary burdens.