Drug Regulatory Affairs

Drug Regulatory Affairs is a compilation of fundamental concepts pertaining to pharmaceutical drug regulation. Governments protect public health by strictly controlling the safety and efficacy of human medicine, veterinary medicines, medical devices, cosmetics and complementary medicines. Companies responsible for the discovery, testing, manufacture and marketing of these products must ensure sale of safe and effective products. Drug Regulatory Affairs refers to fulfilment of all aspects of drug regulations within the pharmaceutical companies from development process to finished product marketing.

The book provides a sound basis on understanding of international drug regulatory guidelines controlling the quality, safety and purity of marketed drugs. The content of this book covers the syllabus of pharmacy undergraduate and postgraduate course content of drug regulatory affairs. The text focuses on delivering updated and reviewed up-to-date information on current global regulatory guidelines. The book contains information that is substantial to a comprehensive understanding of regulatory affairs and the practice in pharmaceutical industry.

Afaceri cu reglementarea medicamentelor este o compilatie de concepte fundamentale referitoare la reglementarea medicamentelor farmaceutice. Guvernele protejeaza sanatatea publica prin controlul strict al sigurantei si eficacitatii medicamentelor umane, medicamentelor veterinare, dispozitivelor medicale, cosmeticelor si medicamentelor complementare.