Implementation of the Clinical Trials Directive in the UK

'The Medicines for Human Use (Clinical Trials) Regulations 2004' (SI 2004/1031) that implement the Clinical Trials Directive were laid before both Houses of Parliament on 1 April 2004 and came into force on 1 May 2004.

The full text can be viewed on the Office of Public Sector Information (OPSI),  and hard copies are available, price £9.00, from The Stationery Office. 
The MHRA has produced a short description of the Regulations  which aims to help those involved in the conduct of clinical trials to follow and understand the Regulations. Also available is a document on access to information and guidance on the UK Clinical Trials Regulations  providing addresses of useful websites. The final regulatory impact assessment document is attached here.

These Regulations help to ensure that the rights, safety and well-being of clinical trial subjects are protected by requiring sponsors of trials to be responsible for designing, conducting, recording and reporting clinical trials according to internationally recognised principles of Good Clinical Practice (GCP).

In addition, the Regulations further protect public health by helping to ensure that the results of clinical trials are collected, recorded and analysed in accordance with those principles so that they can be audited and verified before being used to impact on public health, for example through a publication that changes medical prescribing practice or as evidence to support applications to place medicines on the market.

The Regulations provide a statutory basis for:

• standardisation of procedures for ethical and competent authority consideration and authorisation
• GCP standards for commencing and conducting clinical trials
• Good Manufacturing Practice (GMP) standards for medicines used in clinical trials
• inspections against internationally accepted principles and standards of GCP and GMP, supported by enforcement powers.

 
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 came 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 requirement to share information has been achieved by a Memorandum of Understanding being agreed and signed by the MHRA, the Central Office for Research Ethics Committee (COREC) and the Gene Therapy Advisory Committee (GTAC).
› Medicines for Human Use (Clinical Trials) Regulations 2004 - Memorandum of understanding between MHRA, COREC and GTAC (91Kb)

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)

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.

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