The Medicines and Healthcare products Regulatory Agency (MHRA) is seeking views from the public and other stakeholders in a 3-month long consultation on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MHRA became a regulatory member of the ICH in May 2022.
The ICH E6(R3) GCP guideline supports the MHRA’s ambition to maintain patient safety, alongside enabling and encouraging innovation and risk-proportionate regulation of clinical trials within the UK.
The consultation seeks views on whether the resolutions set out in the ICH reflection and concept papers have been achieved, in addition to soliciting detailed comments on the text. These ICH papers planned to update the guidance to further encourage a proportionate, risk-based approach to the quality management of clinical trials. They focus on addressing innovation in trial design and conduct including the increasing use of new technologies, as well as the protection of rights well-being and safety of trial participants and the reliability of the trial results. Because the ICH Principles of GCP (in section II of the guidance) will form part of the revised UK legislation, the consultation will inform the UK Clinical Trials Regulations.
Following the consultation, feedback from the UK and other ICH members will be reviewed and discussed by the ICH E6 (R3) GCP Expert Working Group which has revised the guidance alongside stakeholder input.
The implementation of this guideline will be a milestone in the MHRA’s programme to give those sponsoring and conducting clinical trials a proportionate framework of good clinical practice, while also demonstrating the agency’s commitment to align with international standards where there is clear benefit in doing so.
The MHRA is seeking the views of those involved in clinical trials of medicines, such as academic researchers, manufacturers, sponsors, contract research organisations, clinical trial service providers, investigators, healthcare professionals and of course patients and clinical trial participants on the proposed guidelines for adoption.
The consultation will close on Thursday 31 August 2023.
Further information
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings regulatory authorities and the pharmaceutical industry together with a mission to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines.
- The ICH Expert Working Group (EWG) for ICH E6(R3) has been revising the ICH E6(R2) Good Clinical Practice (GCP) guideline.
- The MHRA represents the Pharmaceutical Inspection Co-operation Scheme in the ICH E6 EWG.
- The government response to the consultation on legislative proposals to clinical trials confirmed that the ICH Principles of GCP (section II of the guidance) will replace the current GCP principles in the UK legislation that are based on outdated EU legislation.