International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines

[helvella]

For information only - probably of almost zero relevance to most of us, most of the time, but good to know it exists.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines

Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.

Contents

About ICH

Quality Guidelines

Safety Guidelines

Efficacy Guidelines

Multidisciplinary Guidelines

About ICH

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) aims to create an international collaborative network where people can bring forth best practices from their countries, learn from other countries, and implement best practices in their own country. It brings together the regulatory bodies and pharmaceutical industry to look at the scientific and technical aspects of drug registration.

The group discusses the scientific and practical aspects of pharmaceuticals, producing guidelines in four areas – ‘safety’, ‘quality’, ‘efficacy’ and ‘multidisciplinary’. The development and subsequent implementation of these guidelines aims to achieve global harmonisation. The overall aim of ICH is to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.

Before the UK’s exit from the EU, the MHRA was part of ICH under the EU system. Guidelines in use at that time were carried over as EU guidance documents referred to in the Human Medicines Regulations 2012.

Following the UK’s exit from the EU, MHRA became a full Member of ICH in May 2022. This page serves as a directory for current ICH Guidelines which have been implemented by the MHRA.

This page will be updated as new guidelines are implemented by the MHRA.

gov.uk/guidance/internation...

Just to point out that we only had to join the ICH because of brexit. Not that we were unrepresented at ICH before brexit and suddenly became able to be represented there.

[Tina_Maria]

Thanks for that.

All clinical research and clinical trials are conducted according to ICH-GCP clinical guidelines. This is an international requirement to ensure the safety of medicines as well as the safety of participants in clinical trials. The declaration of Helsinki (1964) was put in place by the world medical association to enshrine the rights of subjects participating in medical research. Trials will be conducted according to ICH-GCP and the declaration of Helsinki.

As you have mentioned, the UK was part of the ICH through the EU, so joining after Brexit was just a formality to ensure clinical research can continue to be conducted in the UK according to ICH-GCP guidelines.