MHRA consults public on ICH Good Clinical Practice guideline 15 Jun 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting public feedback on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The ICH E6(R3) GCP guideline aims to support a proportionate, risk-based approach to clinical trials management, particularly in relation to innovative trial design and the use of new technologies.
The MHRA joined the ICH in May 2022 and the ICH Principles of GCP (in section II of the guidance) will form part of the revised UK legislation. Therefore, the consultation will inform the UK Clinical Trials Regulations, which are being updated following the UK’s departure from the European Union.
Those wishing to comment on the guideline have until 31 August 2023 to supply their views. Interested parties can access more information via this link.