About Authors:
Jatin Patel*, Krunal Parikh, Dhiren Shah
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Patelj313@yahoo.com
ABSTRACT:
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
This article includes new drug approval process in different countries include India, Australia, European union, China etc.
New drug approval process in different countries are described in logarithmic representation.