The Medicines and Healthcare products Regulatory Agency (MHRA) will launch a brand new publication—the ‘Good Clinical Practice Guide’ which will cover the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK. Written and produced by the MHRA, this is the only guide on GCP produced by a regulatory authority that is available within Europe.
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.
The guide will cover 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 will also cover 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, Director of Inspection, Enforcement and Standards, MHRA 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.”
EP News Bureau