Journal of Pharmacology and Therapeutic Research

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Journal of Pharmacology and Therapeutic Research 44 7897 074717

Drug Regulatory Affairs

A new molecule can cost several many rupees or dollars to progress and any blunder causes greater impact on company’s status. As medicines play an important role in human’s life there must be regulations for medicines ensuring Quality, Safety and Efficacy of medicine . The regulatory affairs professional is that the just one who is totally liable for holding products in compliance and maintaining all the records. one among the vital activities of the regulatory specialist is to make sure that the all the knowledge regarding medicines has been correctly established to the patient covering labelling also. Even alittle mistake in any of the activities associated with regulatory can make the merchandise to be recall additionally to loss of several many the cash .

Drug development to commercialization is very regulated. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to make sure its safety, efficacy and quality. These standards are set by regulatory authorities of their respective countries like FDA in US and DCA in India etc. Regulation affects all aspects of the pharmaceutical world, from independent innovators and pharmaceutical companies to regulatory and administrative bodies and patients also. Regulatory department is crucial link between company, products and regulatory authorities whose positive or negative standpoint foster the insight of the regulatory agency into the industry, permanently or for bad. So, the higher the scientific precision, the greater are going to be the probabilities for a product to return to the market within the expected time.

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