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.

Post-approval Changes to Drug Substance - Freyr Expertise

Freyr’s team has experience and expertise in handling post-approval changes, including the following:

  • 01

    Change addition/deletion in the manufacturing site.

  • 02

    Support in MAH transfers.

  • 03

    Change in the formulation and batch size.

  • 04

    Optimization of manufacturing process/change in route of synthesis/change in equipment.

  • 05

    Addition/change of active substance supplier/CEP updates/new CEP.

  • 06

    An additional source for active substance starting material.

  • 07

    Pharmacopoeia monograph updates.

  • 08

    Specifications and analytical method changes.

  • 09

    Changes in container closure systems and suppliers.

  • 10

    Shelf-life extension/reduction.

  • 11

    Administrative updates/changes in contact details.

  • 12

    Offering support in post-approval changes to generic drug substances.

Freyr offers the following services to medicinal product manufacturers:

  • 01

    Change control support and change evaluation.

  • 02

    Consultation on submission strategy for proposed changes.

  • 03

    Implementation of strategy and timelines.

  • 04

    Guidance on supporting documents/data.

  • 05

    Preparation of variation submission documentation.

  • 06

    HA interactions for approval and implementation.

  • 07

    CMC Regulatory compliance of legacy dossiers and submissions.

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