Drug regulatory affairs

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DRUG REGULATORY AFFAIRS Introduction 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. REGULATONS: Regulation involves extensive evaluation of a particular drug product to ensure protection of public health, promotion of the product, Drug registration, marketing authorization, import and distribution, pharmacovigilance.

Regulatory Affairs is a comparatively new profession which has developed from the desire of governments to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs is a unique mixture of science and management to achieve a commercially important goal within a drug-development organization. Regulatory Affairs takes care of Development plan, supervising-writing / reviewing and assembling and submission management. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development program and the company as a whole. Generation of various Regulations2 Major incidences made us to understand that rules and regulations are required to prove safety along with efficacy of drug. Such incidences are as follows: -Diphtheria Epidemic led to 1902 Biologics Control Act -Publication of The Jungle by Upton Sinclair led to 1906 Pure Food and Drugs Act -Elixir of Sulfanilamide led to the 1938 Food Drug and Cosmetic Act -Thalidomide led to the 1962 Kefauver-Harris Amendments -Dalkon Shield led to the 1976 Medical Device Amendments -Bjork-Shiley Heart Valves led to the 1990 Safe Medical Devices Act

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