Article | July 23, 2021

ICH's Value To Regulatory

Source: Phlexglobal

By Jim Nichols

How To Align Your Clinical Trials With The Latest Guidance In ICH CGP E6(R2)

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:

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