Global regulatory approaches to post-approval changes in biotherapeutic products

A comparative analysis against WHO guidelines

This article includes a comprehensive analysis of global regulatory frameworks for post-approval changes (PACs) for biotherapeutic products across twenty-one regions from Latin America (LATAM), Asia-Pacific (APAC) and Middle East and Africa (MEA) and compares them to the WHO Guideline on changes on biotherapeutic products. Legislation and guidance were compared for 10 points to assess similarities and differences against the WHO Guideline and 5 PAC CMC scenarios for drug substance and drug product to compare how these changes are addressed under the WHO Guideline versus each country’s specific PAC regulations and guidelines for biotherapeutic products, providing a comprehensive view of their alignment. Convergence level (low, moderate and high convergence) was determined based on change categorization, technical documentation requirements and timeframes for approval. All the outputs were tabulated using colour codes and converted into visual heatmaps to make them easier to digest.

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