INTERNATIONAL CONFERENCE ON HARMONISATION: AN OVERVIEW

  • Chaitanya Prasad Kolla

Abstract

The International Conference on Harmonisation (ICH) is a project that makes together the regulatory bodies of Europe, Japan and the United States and professionals from the pharmaceutical domain in the three areas to discuss scientific and technical views of medicinal product registration. The one aim of ICH is to reduce the need to repeat the testing carried out during the R &D of new Pharmaceuticals by suggesting ways to attain greater harmonisation in the interpretation and application of technical guidelines and requirements for Pharmaceuticals registration. Harmonisation would lead to a more frugal use of human, animal and material resources, and the evacuation of unnecessary time lag in the global development and availability of new Pharmaceuticals while maintaining safeguards on quality, safety, and efficacy, and regulatory duties to protect public health.

Keywords: ICH, QSEM, CTD, MHLW, JPMA, PhMRA, FDA, EU, EFPIA, Quality, Safety, Efficacy, IWG.

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References

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How to Cite
Kolla, C. P. “INTERNATIONAL CONFERENCE ON HARMONISATION: AN OVERVIEW”. International Journal of Drug Regulatory Affairs, Vol. 2, no. 3, Feb. 2018, pp. 19-26, doi:10.22270/ijdra.v2i3.138.