Abstract

GENERIC DRUGS (ANDS) APPROVAL PROCESS IN CANADA: A REVIEW

Sana Khan*, Dr. M. V. Nagabhushanam, T. G. Prathyusha and Santosh Kumar Chamarthi

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. In CANADA. The literature work, 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 Canada lies in its generic drug approval process, generic market and the challenges that Canadian regulatory authority has to overcome in the near future.

Keywords: ANDA, CANADA, REGULATORY REQUIREMENTS, GENERICS, HEALTH CANADA.