MHRA launches consultation on guideline which encourages research innovation

The  3-month long consultation is on the GCP guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The MHRA is a regulatory member of the ICH.

The ICH guideline aims to maintain patient safety and enable and encourage innovation, including the increasing use of new technology in research, and ensure the safety of trial participants and the reliability of trial results.

The consultation seeks views on whether the resolutions set out in the recent ICH reflection and concept papers have been achieved, in addition to asking detailed comments on the text.

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.

Access the consultation.