Food and Drug Laws Affecting Pharmaceutical Product Design, Development, and Commercial Manufacturing

Abstract Every country has its individual sets of laws and regulations for pharmaceutical products; virtually these regulations are comparable with slight differences. The failure of a drug at any stage from discovery, development to marketing leadsto a big loss not only in terms of economically and the reputation of the organization, but also it affects the public health. Any organization that desires to sell its products to a particular authority should have extremely precise knowledge of laws and regulation, although regulatory agencies impart strategic advice in the case of extremely tough verdicts. The regulatory department of an organization has to eradicate the risk with a proper exhibition of clinically safe and effective drug products. They also have to take accountability to manufacture qualitative drug products as per the regulations. The regulatory department acts as interface between regulatory authority of the country and various departments in the organization. It is indulged in every stage of development of a drug even after approval of a drug as well as during marketing. This chapter presents an overview of the regulatory landscape for regulatory agencies which throw a light on how various laws affect diverse aspects of drug discovery. This chapter also explains key regulatory factors involved in the development of new medicinal product that are considered by the pharmaceutical manufacturers and sponsors from development to commercialization of a new drug or medicine.