Regulatory Authorities

The objective of this paper is to give insight and better understanding of the regulatory requirements for changes done for an approved New Drug Application (NDA) in United States (US). For technical advancements, there may be situations which demand/ necessitate modifications for an approved NDA. The changes must be in conformance with the regulatory requirements of the Food and Drug Administration (FDA), the ultimate authority for the Drug related approvals in US. The changes must be systematically reported to the regulatory authorities in the recommended formats, termed as “Post approval changes for an NDA”. Section 506A of Federal Food, Drug, and Cosmetic Act, provides requirements for making and reporting manufacturing changes to an approved application and for distributing a drug product made with such changes. The FDA has revised its regulations on supplements and other changes to an approved application (21 CFR 314.70) to conform to section 506A of the Act. The changes can be major, moderate or minor depending on the changes likely to affect the quality, safety and efficacy of the product. Irrespective of the category of the changes, every change is to be brought to the notice of the US FDA in stringent, structured and stipulated format that are recommended for the regulatory advancements. If manufacturers are to achieve the much-heralded desired state, it is essential to allow some manufacturing changes. Firms would still be responsible for ensuring product quality. The goal is well known, the components needing change are well understood and characterized and the process well defined. Key words: NDA, USFDA, Post approval changes, Regulatory Authorities