Press release: New authoritative guide to Good Clinical Practice

Press release

Date:	24/09/2012
Time:	11:30
Subject:	New authoritative guide to Good Clinical Practice
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) is launching a brand new publication – the ‘Good Clinical Practice Guide’ covers the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.

The ‘Good Clinical Practice Guide’ will be beneficial for any individual or organisation involved in conducting clinical trials with medicines in the UK. This includes both commercial and non-commercial sponsors and hosts of clinical trials, as well as contract research organisations, clinical research consultants and other niche providers. As the guide references European legislation and guidance as well as international standards, it will also be relevant to organisations conducting clinical trials across Europe and beyond.

It is intended that this guide will complement currently available legislation and guidance and provide practical advice about implementing the principles of Good Clinical Practice (GCP) across the wide range of trials conducted in the UK, within the context of the clinical trial regulatory framework in the European Union. Written and produced by the MHRA, this is the only guide on GCP produced by a regulatory authority that is available within Europe.

The guide covers all the different areas of clinical trials, for example sponsor oversight, applying for authorisation for the trial to the MHRA and obtaining an opinion from an Ethics Committee. It also covers the conduct and management of clinical trials in chapters covering the investigational medicinal product, documentation, management of data, safety reporting and quality systems. Specialist topics such as advanced therapies and technologies for managing drug supplies are also included.

Gerald Heddell, MHRA Director of Inspection, Enforcement and Standards said, “It was recognised that there was a need to provide additional information to those involved with GCP and therefore this guide has been produced. While this guide does not replace existing documents on the subject, it does offer valuable practical guidance on GCP and how it is possible to comply within the existing legal framework.”

Notes to Editor

1. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk

2. The Good Clinical Practice Guide is available from The Stationery Office (TSO) website (external link)

3. Good Clinical Practice Guide