Registration Requirements of Medicinal Products for Human Use in Asia: An Emerging Pharmaceutical Market

Abstract

Asia is world’s largest and most populated continent having huge diversity in culture, climate, and government system. Nowadays Asian countries are progressively tightening their healthcare regulation standards. For the successful drug registration in Asia region,local knowledge of healthcare regulations plays vital role for improving the speed, cost and efficiency of introducing new medicines into these markets, thereby allowing timely access to patients. In this dissertation I have described various healthcare regulatory authorities, their registration requirements including types of application, registration fees, approval timeline, stability data requirements and requirements for change in registration of product particulars. Regulatory aspects of these countries are developing and changing constantly. Hence, regulatory professionals need to be updated with the current regulations.