Post-Approval Management of An Anda Approved Drug Product

Abstract

“Change is un-evitable” quoted John C. Maxwell; this quote can be felicitous to ANDA application as well besides literature. Pharmaceutical industry being the most regulated and stringent, demands even a nugatory change to be documented and reported to the agency. The purpose of this project is to provide clear insight on the management of an already approved ANDA drug product. ANDA application which is submitted to agency (US-FDA) for generic product approval takes around 10months for review by FDA if any deficiency during review does not affect the review clock. However this approved ANDA entails post approval management until the drug product is in commercial distribution. “Amendments and Supplements” or say “pre-approval amendments and post approval supplements”. That is how they can be differentiated. Post approval management of an ANDA involves reporting changes to ANDA, Annual reports. It is equally important for applicant to identify the befitting change category alongside reporting. Agency has laid down proper guidance to help applicants identify the reportable category and germane documents.FDA through its guidance has divided post approval changes into categories based on the severity of change to affects the drug product. Changes are divided changes into major, moderate and minor changes based on its potential to affect the drug product. Major changes having substantial potential to impact the drug product requires the submission of PAS, followed by moderate changes which have modest potential to impact the product. Moderate changes are further breakdown into 2 categories i.e. CBE-0 & CBE-30.Agency through its SUPAC guidelines has also tried to provide recommendation to applicant regarding various changes and define the level of change into 3 levels i.e. Level-1, Level-2 and Level-3 change. The thesis work emphasizes on reporting changes to the agency through proper reporting categories. Inclusion of alternate Vendor of API has been reported through PAS, the relevant document has also been attested with the submission. It has been categorized as PAS since it comes under major change due to change in vendor’s route of synthesis or process. Case based hypothetical dossiers have been made and discussed in the thesis work. ix Similarly, change in labeling has been made by CBE-0, following safety labeling change notification by the agency. A minor change is also discussed in the submission through annual report content, format and a hypothetical report.