Post-approval activities of ANDA are equally important throughout the lifecycle of a generic drug product. After the approval of generic drug application and during the commercialization of the drug product, manufacturers may propose certain changes to an approved ANDA/DMF to optimize the operational cost or increase productivity or due to administrative reasons. These post-approval changes are submitted to the USFDA by filing supplements or amendments in accordance with the section 506A of the Federal Food, Drug, and Cosmetic Act and § 314.70 (21 CFR 314.70).
Based on the impact and complexity, changes have been categorised as major, moderate and minor, and the type of submissions, as well as the necessity for prior approval from the USFDA, before the implementation of the change.
Timely submission of the respective supplement/amendment/annual report is very critical to maintain the lifecycle of the product and to be Regulatory complaint. Preparation of post-approval submission strategy is critical to avoid rejections from the USFDA, in case of the inappropriate categorization of the change.
Freyr’s Regulatory affairs team has extensive knowledge and experience in handling post-approval changes to ANDA and DMF with their submissions to the USFDA in alignment with the requirements and guidelines.
Freyr’s team has experience and expertise in handling the following post-approval changes with submissions to the USFDA.
Change/addition/deletion in manufacturing site
ANDA/DMF holder transfers
Optimization of manufacturing process/change in route of synthesis/change in equipment
Change in formulation/batch size change
Addition of new supplier for active substance/CEP updates/new CEP
Inclusion of additional source for starting material for drug substance
Monograph updates i.e. CMC Regulatory compliance to the US Pharmacopoeia
Specifications and Analytical method changes
Changes in container closure system and suppliers
Administrative updates/contact details changes
CMC Regulatory compliance
Freyr offers the following services to the Medicinal Products Manufacturers:
Change controls/proposed changes evaluation
Provide consulting on submission strategy for proposed changes
Implementation strategy and timelines
Guidance on supporting documents/data
Preparation of supplement/amendment/annual reports
Interaction and follow-ups with Health Authorities for approval and implementation
CMC Regulatory compliance of legacy dossiers/submissions with post-approval supplements