Regulatory requirement for Pre & Post-approval management of Generic Drugs in US

  • Rajveer Bhaskar
  • Monika Ola
  • Bhupesh Patil Research Scholar, Department of Regulatory Affairs, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dist. Dhule, Maharashtra, India 425405


FDA is a federal agency within the Department of Health and Human Services & important regulated body. In accordance with FDA regulations under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) this review explains how to file an abbreviated new drug application (ANDA). The data in an ANDA Submission to FDA, CDER, Office of Generic Drugs, allows for the evaluation and potential authorization for a generic drug product. After receiving approval, an application is allowed to manufacture and market the generic drug product so that the general public has access to a secure, efficient, and affordable substitute.

A generic medicine is a therapeutically equivalent, safe, and more affordable substitute for the market-leading innovator or branded drug. The US has one of the most stringent regulatory authorities. The application to be submitted for registering generic drugs is known as an ANDA. Making sure that medication development, manufacture, and testing have been done in accordance with the rules and norms and that everything has been properly documented is one of the regulatory authorities' key responsibilities. The International Conference on Harmonization (ICH) created a standardized application format for registering medicinal products. In order to obtain market authorization in the US, this paper addresses the generic medication registration requirements in the form of an eCTD dossier.

The term "post approval changes" refers to modifications made to the approved generic and marketed drug products. These modifications are made in order to provide the data necessary to assess whether the proposed changes will have an adverse effect on the quality of the approved products in terms of their safety, efficacy, and effectiveness. The applicant may make post-approval amendments after the NDA or ANDA has been approved, provided that the changes are disclosed to the FDA in accordance with the necessary categories. Company change control processes should include information on how changes are assessed, implemented, and effect on product stability along with appropriate data and justification required justifying the proposed change. Based on an examination of the technical evaluation of the change and the pertinent regulatory guidelines, the regulatory group will determine the submission method.

Keywords: Orange Book, CDER, ANDA, NDA, FDA, Paragraph IV certifications, RTR, Generic drugs, Common technical document, USFDA, Hatch Waxman act, Post-Approval Changes, SUPAC guidelines


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How to Cite
Bhaskar, R., M. Ola, and B. Patil. “Regulatory Requirement for Pre & Post-Approval Management of Generic Drugs in US”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 94-109, doi:10.22270/ijdra.v11i2.611.