International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world. ICH aims to achieve greater harmonisation worldwide for the development and approval of safe, effective, and high-quality medicines in the most resource-efficient manner. The European Medicines Agency (EMA), in collaboration with EU Member States, supports the European Commission's membership in ICH and plays a key role in the development and implementation of ICH guidelines .
The Council was officially established on 23 October 2015, after 25 years as the International Conference on Harmonisation. The reformed ICH is intended to transform ICH into a truly global initiative supported by a robust and transparent governance structure.
ICH achieves harmonisation through developing guidelines and technical requirements for the development, approval and safety monitoring of medicines involving regulatory and industry experts. ICH regulatory members adopt the guidelines and are expected to implement them.
The objectives and activities of ICH are similar to those of the International Cooperation for Harmonisation of Technical Requirements for Pharmaceuticals for Veterinary Medicinal Use (VICH).
- guidelines on quality, safety and efficacy as the main criteria for authorising new medicines and monitoring their safety;
- electronic standards for the transfer of regulatory information;
- the common technical document (CTD), a common format for quality, safety and efficacy information;
- the medical dictionary for adverse event reporting and coding of clinical trial data (MedDRA), which comprises standardised medical terms to facilitate sharing of regulatory information internationally for human medicines.
Update: The results of a survey commissioned by ICH show that the EC and EMA, in collaboration with EU Member States, adequately implement and adhere to ICH guidelines, without introducing unjustified modifications:
These results are part of a 2019 study to monitor the adequacy of implementation and adherence to ICH guidelines in regulatory member and observer countries and regions. The study report provides a gap analysis based on authorities’ and companies’ views on the implementation and adherence of regulators to ICH guidelines. It reveals a close alignment between the self-declaration of the authorities and perception among companies.
EMA acts as technical coordinator for ICH activities and plays a key role in EU contributions to ICH topics are developed and communicated in a timely manner. European experts nominated by the CHMP participate in the expert working groups that draft the guidelines, and can act as chair or rapporteur responsible for leading the group's work.
Once an ICH guideline has been finalised, the CHMP is responsible for implementing it as a European guideline. All harmonised guidelines are published on the EMA website on Scientific guidelines: ICH guidelines.
The Agency also sits on the management board for the Medical Dictionary for Regulatory Activities (MedDRA).