Pharmaceutical Regulatory Affairs News

Pharmaceutical Regulatory Affairs News

A new molecule can cost several millions of rupees or dollars to progress and any blunder causes greater impact on company’s status. As medicines play a vital role in human’s life there must be regulations for medicines ensuring Quality, Safety and Efficacy of drugs. The regulatory affairs professional is the only one who is completely responsible for holding products in compliance and maintaining all the records. One of the vital activities of the regulatory specialist is to ensure that the all the information regarding medicines has been correctly established to the patient covering labelling also. Even a small mistake in any of the activities related to regulatory can make the product to be recall in addition to loss of several millions of the money. Drug development to commercialization is highly regulated. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. These standards are set by regulatory authorities of their respective countries such as 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 authority into the industry, for good or for bad. So, the better the scientific precision, the greater will be the chances for a product to come to the market within the expected time.


Last Updated on: Nov 26, 2024

Global Scientific Words in Pharmaceutical Sciences