The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner.
Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines.
With ICH’s establishment as an international non-profit Association under Swiss law on October 23, 2015, ICH’s mission has been embodied in its Articles of Association as follows:
- To make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations;
- To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical products;
- To contribute to the protection of public health in the interest of patients from an international perspective;
- To monitor and update harmonised technical requirements leading to a greater mutual acceptance of research and development data;
- To avoid divergent future requirements through harmonisation of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products;
- To facilitate the adoption of new or improved technical research and development approaches which update or replace current practices;
- To encourage the implementation and integration of common standards through the dissemination of, the communication of information about and provision of training on, harmonised guidelines and their use;
- And to develop policy for the ICH Medical Dictionary for Regulatory Activities Terminology (MedDRA) whilst ensuring the scientific and technical maintenance, development and dissemination of MedDRA as a standardised dictionary which facilitates the sharing of regulatory information internationally for medicinal products used by humans.
As outlined in ICH’s multi-annual strategic plan, the organization
|Harmonisation||Progress harmonisation activities on all approved proposals for ICH topics – Annex I provides a multiyear overview of harmonisation activities on current ICH topics
Assess / approve on a regular basis proposals for new ICH topics according to an agreed process in order to keep an ongoing stream of harmonisation activities based on the total number of concurrent technical WGs which the Association can support at a given time
|Communication||Ensure appropriate communication and transparency with stakeholders on ICH activities|
|Procedures||Maintain / update as necessary the Rules of Procedure (RoP) for the Assembly, the Management
Committee, the MedDRA Management Committee and Standard Operating Procedures (SOPs) for the technical working groups (WG)
|Operations||Process / decide on applications for ICH Membership and Observership in an efficient manner
Introduce membership fees to be payable by all Members starting in 2018
Determine the medium to long term financial needs of the organization
Open-up the Management Committee to Elected Representatives no later than January 2018 in line with Article 27(3) of the ICH Articles of Association
Complete all legal, fiscal and administrative steps necessary for a fully operational Association with an entirely autonomous Secretariat
Organise annual audits of the Association’s accounts starting in 2017 with an audit of the 2016 accounts
Implement agreed-upon strategic approach for training on ICH Guidelines
In the areas most closely related to Regulatory Operations, the ICH topics included in the multi-annual strategic plan include:
- E2B(R3) IWG – Revision of Electronic Submission of ICSRs – Focused on clinical safety data management and the data elements for transmission of individual case safety reports. More information can be found here: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/clinical-safety-data-management-data-elements-for-transmission-of-individual-case-safety-reports.html
- M2 ESG – Electronic Standards for the Transfer of Regulatory Information – with its core focused on the Common Technical Document (CTD). More information can be found here: http://www.ich.org/products/ctd.html
- M8 EWG/IWG – Electronic CTD – currently focused on eCTD v4 standards. More information can be found here: http://estri.ich.org/new-eCTD/index.htm
The Value of Involvement
ICH is a truly global platform for harmonisation for better health, bringing together regulators, industry and other actors from all regions. It has a 25-year history as a successful and proven forum for delivery of harmonised guidelines through dialogue between regulators and industry. Here are some of the values and advantages of ICH Membership:
Demonstrates a commitment to high standards for public health
Becoming a Member of the ICH Association sends a clear message that the regulatory authority and the regulated industry are committed to align with the highest global standards for the quality, efficacy and safety of medicinal products. Membership in ICH brings with it integrity and recognition as ICH guidelines are widely recognised and are increasingly applied worldwide. With ICH Membership also comes the right to use the ICH Member Logo to denote Membership in a Member’s own publications, presentations or on their website.
Allows participation in international harmonisation
Being an ICH Member gives the opportunity to be fully involved in the public health work on achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product development and registration.
Gives a say on the technical and policy environment of the future
All ICH Members participate in the consensus-building and decision-making in the ICH Assembly. They can also propose new topics, participate in the selection of topics for harmonisation, and nominate technical experts to contribute to current harmonisation activities (in accordance with the Rules of Procedures). Where consensus cannot be reached, the Regulatory Members have the right to vote on items such as the endorsement of draft ICH guidelines and adoption of final ICH guidelines.
Provides input to ICH governance
All Members have a say on ICH operational decisions such as approval of new Members, Observers, annual budget and membership fees. And from 2018, all Members will have the possibility to be elected to the ICH Management Committee.
Provides an international forum for communication and the building of relationships
Membership in ICH allows for building and strengthening working relations between Members. For Regulatory Members in particular, harmonisation at multilateral level provides a strong common foundation to develop bilateral regulatory cooperation such as on the exchange of information, training and reliance practices.
Helps to stay informed
In addition to the information available on the ICH public website, Members are regularly updated on a broad range of information on ICH and on other related activities.