Abstract

REGULATORY REQUIREMENTS FOR SUBMISSION OF GENERICS IN DEVELOPED COUNTRIES (TGA, USFDA, PMDA, CDSCO): A REVIEW

Santosh Kumar Ch.*, D. Nagarjunareddy and M. V. Nagabhushanam

Abstract

A regulatory requirement for generic drug development has the impact on launching the drug into the market. The regulatory documents which are going to submitted to the regulatory agencies should be carefully reviewed by the skilled professional to minimize the queries raised by the regulatory agencies and speed up the approval process. These are few differences in dossier submission requirements among the four regions i.e., Australia, USA, JAPAN, INDIA which has been clearly explained through sufficient comparisons in this work. The literature work, the comparison parameters, difference in generic drug approval requirements has been studied and explained in detailed in this work, which gives the clear over view of the role of generics in the world market and where India lies in its generic drug approval process, generic market and the challenges that Indian regulatory authority has to overcome in the near future.

Keywords: Regulatory affairs, Process approval, India, USA, Australia, Japan and Generics.