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<p>The efficient review and approval of chemistry, manufacturing and control (CMC) post-approval changes by global health authorities remains a critical aspect toward ensuring medical product commercial supply chains and patient access. The recent and growing implementation of innovative regulatory frameworks such as ICH Q12, large molecule statistical analysis of stability data, and global reliance has provided a positive impact on the health authority approval of CMC post-approval changes. This case study presents a large molecule multi-product post-approval change management protocol (PACMP) and the review/approval by a WHO-Listed&#xa0;Authority (WLA). The regulatory approval of this PACMP exemplifies how the principles of ICH Q12 combined with large molecule statistical stability analysis accelerates the implementation of a drug product aseptic filling line supporting the production of 5 globally approved products by 7 months. This accelerated approval by a WLA leads to the faster submission of the required approval letter/module 3 documentation to global national regulatory authorities leveraging WHO Good Reliance Procedures to improve rest-of-world regulatory review/approval timelines.</p> Graphical Abstract <p></p>

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Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP

  • 期刊论文

  • 发表日期：

    2025年10月3日

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  • Sunny Kamlesh Dave,
  • Christine Ørting,
  • Scott W. Roberts

摘要

The efficient review and approval of chemistry, manufacturing and control (CMC) post-approval changes by global health authorities remains a critical aspect toward ensuring medical product commercial supply chains and patient access. The recent and growing implementation of innovative regulatory frameworks such as ICH Q12, large molecule statistical analysis of stability data, and global reliance has provided a positive impact on the health authority approval of CMC post-approval changes. This case study presents a large molecule multi-product post-approval change management protocol (PACMP) and the review/approval by a WHO-Listed Authority (WLA). The regulatory approval of this PACMP exemplifies how the principles of ICH Q12 combined with large molecule statistical stability analysis accelerates the implementation of a drug product aseptic filling line supporting the production of 5 globally approved products by 7 months. This accelerated approval by a WLA leads to the faster submission of the required approval letter/module 3 documentation to global national regulatory authorities leveraging WHO Good Reliance Procedures to improve rest-of-world regulatory review/approval timelines.

Graphical Abstract