Abstract

A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE, INDIA, AUSTRALIA, JAPAN

Rakshita Patel, Jaya Patel*, Sachin Sharma and Dr. Ketan Shah

ABSTRACT

This review paper includes, Drug Approval process of different countries like USA, Europe, India, Australia, Japan. Nowadays, the regulatory requirements for approval of a new drug in the various countries of the world are quite different. Therefore, it is very important to know in detail the regulatory requirements in each country where an MAA should be submitted to establish a suitable regulatory strategy before the submission in order to avoid any major difficulties. The new drug approval is of two-phase process, clinical trials phase & Marketing authorization of drug.

Keywords: New drug approval, Drug Approval procedure, Approval stages, USFDA, CDSCO, DCGI.