Post Approval Regulatory Compliance Management for Generics in U.S. Market

Abstract

Generic drugs play an increasing role in the healthcare system, saving billions of dollars each year while providing equivalent therapeutic effects just as their brand name counterpart. The United States (U.S.) is one of the major markets for Indian generics manufacturers to market their drug products. Approval of Abbreviated New Drug Application (ANDA) enables a pharmaceutical manufacturer to market its generic products in U.S. There are various regulatory requirements that need to be complied with once a drug product is marketed. Changes being inevitable can come up anytime during the life cycle of a drug product and these changes must be in conformance with the regulatory requirements of the Food and Drug Administration (FDA), the drug regulatory authority in U.S. These changes are called as “Post Approval Changes” and must be systematically reported to the U.S. FDA. The various Post Approval Changes and their reporting formats and requirements in U.S. along with a brief comparison to the requirements in the European Union (EU) are described in this dissertation work. As part of post approval compliance, it is mandatory for the ANDA Holder to submit Annual Reports to the FDA every year to provide current status of their generic product being marketed in U.S. Another regulatory requirement is that of safety reporting; it is necessary for the ANDA Holder to give an account of the adverse events occurring because of the drug products to the FDA. The various reports that need to be submitted for this purpose to FDA along with a brief comparison of the safety reporting requirements of U.S. and EU are described in this thesis. Due to limited scope, this thesis focuses on Post Approval Changes Reporting, Annual Reports, Change Control System present in a Pharmaceutical Company and Post Approval Safety Reporting. Complying with these post approval requirements is of great importance for Generic Manufacturers to maintain the marketing status of their drug products in U.S.