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

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Medicines Healthcare Products Regulatory Agency

December 19

16:14 2024

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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 UKs 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 UKs 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.

Quality Guidelines

Safety Guidelines

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