Good Clinical Practice Directive: Implementation

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 - SI 2006/1928

The Medicines for Human Use (Clinical Trials) Amendment Regulations (the Amendment Regulations) were laid in Parliament  on 20 July 2006 and will come into force on 29 August 2006. The Amendment Regulations principally implement Commission Directive 2005/28/EC1 (the Good Clinica l Practice (GCP) Directive) by amending the Clinical Trials Regulations2  which implement the Clinical Trials Directive3.

The provisions implementing the GCP Directive relate to: sponsor's delegation of functions; content and presentation of the investigator's brochure; qualifications and procedures for inspectors; retention of documents and archiving; sharing of information between ethics committees and the licensing authority; scope of manufacturing authorisations and procedures for their holders; and wording of principles of Good Clinical Practice.

The Amendment Regulations also include additional changes to the Clinical Trials Regulations which do not arise out of the GCP Directive. These additional provisions relate to arrangements for payment of fees; notifying the licensing authority of serious breaches of GCP and/or the protocol; and the extension of the infringement notices (warning notices) regime.

The Amendment Regulations also correct various minor errors in the Clinical Trials Regulations.

The consultation exercise on the Amendment Regulations (MLX 328 (see below)) ran from November 2005 to February 2006. A summary of the 75 responses received is available below:
› MLX 328 (548Kb)
› MLX 328: Summary of responses (143Kb)

The Amendment Regulations are available on the Office of Public Sector Information website:
› The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 - SI 2006/1928 (external link)

For further information contact the Clinical Trials Unit, 12-2, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2327, fax 020 7084 2443 or e-mail the clinical trial helpline (clintrialhelpline@mhra.gsi.gov.uk).

 

 

1Commission Directive 2005/28/EC of 8 April 2005 laying down the principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
2 The Medicines for Human Use (Clinical Trials) Regulations  2004 SI [2004/1031] which implement Directive 2001/20/EC.
3  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.