Abstract
The pharmaceutical sector is a high-technology, knowledgeintensive and heavily regulated industry. All aspects of the life-cycle of new drugs are regulated, from patent application to marketing approval, commercial exploitation, patent expiration and competition with generics. All the important actors in the pharmaceutical industry: the manufacturers, wholesalers, retailers and prescribing physicians are subject to regulatory controls. This helps to ensure the product efficacy and safety which are not immediately observable. This article discusses about the regulatory practice in pharmaceutical industry with respect to various facets of drug development.
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