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Abstract

REGULATORY REQUIREMENTS FOR NEW DRUG APPROVAL IN DIFFERENT COUNTRIES: AN OVERVIEW

Sonal Jain*

ABSTRACT

A new drug development process requires extensive research in terms of chemistry, manufacturing, controls, preclinical and clinical trials. It is a huge responsibility of drug reviewers in regulatory agencies across the globe of evaluating the authenticity of research data supporting the safety, effectiveness and quality control of a new drug product to serve the public health. This review emphasizes on the regulatory requirements for attaining MA for new drugs in United States Food & Drug Administration (USFDA), European Medicines Agency (EMA), Japan, China, Australian region and India based on the regulatory guidelines as laid by them. There is focus on Investigational new drug (IND) and New drug application (NDA) as USFDA requirements. In EU, the procedure comprise of four different processes: Centralized Procedure, Decentralized Procedure, National Procedure and, Mutual Recognition Procedure. In India, CDSCO is the primary regulatory authority to get MA for new drugs. Similarly, SDFA, PMDA and TGA are main regulatory authorities in China, Japan and Australia for reviewing efficacy and safety data and thus granting MA for new drugs in these countries.

Keywords: Central Drugs Standards Control Organization(CDSCO), Drug Lag, European Medicines Agency (EMA), European Union(EU), US Food and Drug Administration (USFDA), Marketing Authorization (MA), Pharmaceuticals and Medical Devices Agency (PMDA), State Food and Dr


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