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.
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:
- Adequacy of Implementation and Adherence to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines: centralised procedure with EMA
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.
EMA supports ICH in its efforts to obtain early stakeholder input on a regional basis towards its good clinical practice (GCP) renovation process, by gathering the views and engaging European stakeholders via its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties
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 of ICH's Medical Dictionary for Regulatory Activities (MedDRA).
EMA is supporting ICH's pilot regional stakeholder engagement approach for the moderinsation of its good clinical practice guidance (ICH E6(R3)), by facilitating the obtaining of the relevant input in Europe via its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties. The feedback gathered via EMA in Europe, along with
EMA is coordinating the stakeholder engagement process in Europe for the revision of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 good clinical practice (GCP) guideline.
This is to help ensure that the perspectives of European patients, healthcare professionals and clinical researchers are taken into account during the revision process.
ICH has committed itself to engaging stakeholders from the outset of the revision process for this guideline. This aims to ensure that the revised guideline will meet the needs of those conducting or participating in clinical trials.
As a first step, EMA held a workshop with its Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties in June 2020 to gather their views and experiences. The workshop summary report is available:
For more information on the ICH E6 revision process, see:
The reflection paper on patent paper identifies key areas where incorporation of the patient’s perspective could improve the quality, relevance, safety and efficiency of drug development and inform regulatory decision making. It also presents opportunities for development of new ICH guidelines to provide a globally harmonized approach to inclusion of the patient’s perspective in a way that is methodologically sound and sustainable for both regulated industry and regulatory authorities.
This reflection paper has been updated as a result of the public consultation process initiated by ICH to gather public comments from relevant (non-ICH) stakeholders. Furthermore, when the proposed guideline work advances, this will include plans for further public consultation and engagement.
EMA is a co-sponsor of the reflection paper.
Outcome of public consultation on ICH reflection paper on proposed ICH guideline work to advance patient focused drug development (PFDD) (PDF/279.53 KB)
First published: 24/06/2021
ICH reflection paper - proposed ICH guideline work to advance Patient Focused Drug Development (PFDD) (PDF/298.29 KB)Draft
First published: 24/06/2021
Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (PDF/612.57 KB)
First published: 14/04/2021
ICH reflection paper on proposed ICH guideline work to advance patient focused drug development (PDF/313.44 KB)Draft: consultation closed
First published: 10/12/2020
Consultation dates: 10/12/2020 to 07/03/2021
New: A reflection paper is available for public consultation aiming to harmonise real-world evidence terminology and enable the convergence of general principles for planning and reporting studies using real-world data to support regulatory decision-making.
It builds on the 2022 statement from the International Coalition of Medicines Regulatory Authorities (ICMRA), offering a strategic approach for future ICH guidelines on the assessment of real-world data and real-world evidence.
The reflection paper identifies the following areas for harmonisation:
EMA encourages medicine regulators, academic researchers, the pharmaceutical industry and other stakeholders to comment.
The document contains a link to the submission form for comments.
The public consultation is open until 30 September 2023.
EMA is coordinating the public consultation in Europe in parallel with a consultation run by ICH, to ensure European stakeholders have the opportunity to comment.
The reflection paper was released by the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and co-sponsored by EMA, the United States of America's (USA) Food and Drug Administration (FDA), and Health Canada.
ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines (PDF/390.54 KB)Draft: consultation closed
First published: 06/07/2023
Consultation dates: 30/06/2023 to 30/09/2023