Post-approval Changes to Drug Substance

Post-approval Changes to Drug Substance - Overview

Post-approval changes to drug substances can arise throughout the lifecycle of a drug product and must be addressed appropriately. After the approval and during its commercialization, manufacturers may propose certain changes to a product and/or the active substance for optimizing operational costs, increasing productivity, administrative reasons, etc.

Evaluation of such changes must determine whether a submission to the relevant Health Authorities (HAs) is necessary, and if it is, a variation package must be prepared. The submission required might be a Type IA, IA, IB, or Type II variation package, depending on the categorization of the change in accordance with the relevant variation guidelines.

Changes requiring HA approval must only be implemented after it has been granted, and in many cases, the implementation may be done within a defined period following the approval. Robust post-approval submission strategies and accurate change categorization are critical to minimize HA questions and rejections.

In order to maintain compliance, timely submission of changes is essential during the lifecycle of drug products. Freyr’s Regulatory affairs team has extensive experience in handling CMC post-approval changes and the required submissions to European HAs in alignment with the relevant requirements and guidelines.