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Antimicrobial resistance in human medicine

Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods) most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals [1-4]. The current Pharmaceutical Industry is well organized, systematic and compliant to international regulatory standards for manufacturing of Chemical and Biological drugs for human and veterinary consumption as well as medical devices, traditional herbal products and cosmetics. Stringent GMPs are being followed for blood and its derivative as well as controlled manufacturing for Traditional Herbal Medicines, Cosmetics, Food and Dietary products which was otherwise differently a century before. Each regulatory system had faced certain circumstances which led to current well-defined controlled regulatory framework. This has resulted into systematic manufacturing and marketing of safe, efficacious and qualitative drugs. With the growth of industry, the legislations from each region have become more and more complex and created a need for regulatory professionals [2]. To understand the chronological development of the modern era of pharmaceutical industry and regulatory framework, we will glance through the historical evolution of regulations in USA, Europe and India