Policy responses and statements

Name of organisation:

Medicines and Healthcare Products Regulatory Agency

Name of policy document:

MLX 328: Consultation on Implementation of the European Commission's Directive on Good Clinical Practice (2005/28/EC)

Deadline for response:

7 February 2006

Background: The UK Clinical Trials Regulations in 2004 implemented the original EU Clinical Trials Directive of 2001. This 2001 Directive has now been added to by the 2005 Directive (the 2005 Good Clinical Practice (GCP) Directive), and a revised set of Regulations will be needed in order to reflect the provisions of the new Directive. The Government therefore proposes to amend the Regulations, both to align them with the 2005 GCP Directive, and to implement some other detailed requirements. This consultation sought views on the proposed arrangements.

COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
MLX 328: CONSULTATION ON IMPLEMENTATION OF THE EUROPEAN COMMISSION'S DIRECTIVE ON GOOD CLINICAL PRACTICE (2005/28/EC)

The Royal College of Physicians of Edinburgh is pleased to respond to the Medicines and Healthcare Products Regulatory Agency on MLX 328: Consultation on Implementation of the European Commission's Directive on Good Clinical Practice (2005/28/EC).

The College has few comments on the proposals to amend the regulations to comply with the provisions of the Commission Directive on Good Clinical Practice. The College supports efforts to improve and protect standards of research conduct, and has been instrumental in establishing a national panel to investigate research misconduct. However, in common with many other organisations, the College continues to have significant concern about the impact of the Commission Directive on non-commercial (largely university and NHS funded) research. This consultation document implies that there may be greater flexibility in the interpretation of the Directive than first suggested, and we will be pleased to comment more fully on the proposed guidance for “specific modalities” when it is available.

Copies of this response are available from:

Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.

Tel: 0131 225 7324    ext 608
Fax: 0131 220 3939

[26 January 2006]