International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an initiative that brings together regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration.^[1]

Harmonisation leads to a more rational use of human, animal and other resources, the elimination of unnecessary delay in the global development, and availability of new medicines while maintaining safeguards on quality, safety, efficacy, and regulatory obligations to protect public health. Junod notes in her 2005 treatise on Clinical Drug Trials that "Above all, the ICH has succeeded in aligning clinical trial requirements."^[2]

^ Mullin Theresa (17 Nov 2017). "International Regulation of Drugs and Biological Products". In Gallin, John I.; Ognibene, Frederick P.; Lee Johnson, Laura (eds.). Principles and Practice of Clinical Research. Academic Press. p. 88.
^ Junod, Valerie (2005). Clinical drug trials - Studying the safety and efficacy of new pharmaceuticals. (thesis for Faculté de droit de Genève) Bruxelles: Bruylant. p. 107.

[1] Mullin Theresa (17 Nov 2017). "International Regulation of Drugs and Biological Products". In Gallin, John I.; Ognibene, Frederick P.; Lee Johnson, Laura (eds.). Principles and Practice of Clinical Research. Academic Press. p. 88.

[junod05-2] Junod, Valerie (2005). Clinical drug trials - Studying the safety and efficacy of new pharmaceuticals. (thesis for Faculté de droit de Genève) Bruxelles: Bruylant. p. 107.

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