Abstract

STEPS FOR OBTAINING MARKETING AUTHORIZATION FOR DRUGS

*Neha Chauhan and Dr. Shanthakumar G. S.

ABSTRACT

These days, the restrictive needs for approval of a brand-new drug within the numerous countries of the globe are quite totally different. To develop one single restrictive approach for marketing authorization application (MAA) of a brand-new drug product for numerous countries is utmost troublesome task- particularly for corporations with international activities. Therefore, it's vital to grasp intimately the regulatory needs in every country wherever associate MAA ought to be submitted to determine an acceptable regulatory strategy before the submission so as to avoid any major difficulties. The new drug approval is of two-phase method, clinical trials part & marketing authorization of drug. The article relies on the procedures for drug approval in numerous countries like Canada, India, USA, China, Australia, European countries and Turkey.

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