Abstract
In the year 1962, Food and Drug Administration (FDA) approved for the 1 st time the concept of efficacy along with safety for new drug application (NDA), through Kefauver-Harris amendment, which revolutionized the drug development. In 1989, international conference of drug regulatory authorities organized by World health organization in Paris revealed the need for harmonization of requirements, which lead to the establishment of registration of pharmaceuticals for human use (ICH) in 1990. In consonance with these guidelines, FDA emphasized on scientific principles of risk based processes, product development and commercialization, which are underlined in ICH Q8 for pharmaceutical development, ICH Q9 for quality risk management, ICH Q10 for pharmaceutical quality system.
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1 Former Professor, Department of Pharmaceutics, Jamia Hamdard, Hamdard University, New Delhi, Principal, B. S. Anangpuria Institute of Pharmacy, Faridabad, Haryana