Main aim of Regulatory affairs in pharmaceutical industry is to protect human health. The purpose of drug is to diagnose, prevent or treat diseases or ailments in humans, they are products intimately linked with the advances in research and regulation. People and government spent money on drugs because of the role they can play in saving lives, restoring health, preventing diseases and stopping epidemics. But, in order to do so, drug must be safe, effective and of good quality. The primary components should be regulated by Drug Regulatory Agencies like, product registration, regulation of drug manufacturing, importation and distribution, regulation of drug promotion and information. The pharmaceutical industry, while pursuing an international market, is obliged to comply with national regulations. So, in this review article, an overview of few drug regulatory agencies: India, Europe, Japan, US is covered.
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