Harmonisation for Better Health

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.

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"Coming together is a beginning. Keeping together is progress. Working together is success."

Henry Ford