Role of ICH guidelines in registration of Pharmaceutical Products

  • Shivali Rahi Advanced Institute of Pharmacy, Palwal, Haryana, India - 121102.
  • Arpana Rana Advanced Institute of Pharmacy, Palwal, Haryana, India - 121102

Abstract

   The International Conference on Harmonization (ICH) of Technical Requirements is a unique project for Registration of Pharmaceutical products which are intended for human use. This brings together the regulatory authorities of Europe, Japan and United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.


The purpose is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.


       The objective of such harmonization is a more economical use of human, animal and material resources and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy and regulatory obligations to protect public health. It creates a venue that allows all key pharmaceutical regulatory authorities and industry stakeholders the opportunity to be more actively involved in pharmaceutical harmonization work. It aimed at the standardization of requirements and format along with the content of regulatory documentation and brings down the pressure on the price of medicines by enabling greater economies of scale and a labelled regulatory playing field. This paper is an effort to provide the detailed information about ICH Guidelines.

Keywords: ICH, QSEM, Regulatory, Technical, Harmonization, MedDRA

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How to Cite
Rahi, S., and A. Rana. “Role of ICH Guidelines in Registration of Pharmaceutical Products”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 4, Dec. 2019, pp. 14-27, doi:10.22270/ijdra.v7i4.365.