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Revised ICH Terms of Reference 

 

To maintain a forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients;

 

To contribute to the protection of public health 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, where these permit a more economical use of human, animal and material resources, without compromising safety;

 

To facilitate the dissemination and communication of information on harmonised guidelines and their use such as to encourage the implementation and integration of common standards