Reminder - Public consultation on the revised International Council for Harmonisation (ICH) on Good Clinical Practice (GCP) guidelines

We are seeking the views from the public in our 3-month long public consultation on the Good Clinical Practice (GCP) guideline revised by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). This guideline gives those sponsoring and conducting clinical trials a proportionate framework of GCP.

We would like to hear from 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 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. The consultation will also inform the UK Clinical Trials Regulations.

Find out more and share your views.

The consultation will close on Thursday, 31 August 2023.

Please share this email with your networks and contacts so that we can get the broadest possible response.

Thank you for your support.

Kind regards,

The Medicines and Healthcare products Regulatory Agency

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