China’s CDE (NMPA) has issued draft guidelines to standardize manufacturing and testing procedures for recombinant monoclonal antibody biopharmaceuticals and improve regulatory clarity.
Key highlights:
- Introduces a unified format for manufacturing and testing procedures to support efficient review
- Applies to monoclonal antibodies, bispecifics, and fusion proteins with scope for product-specific adjustments
- Defines facility, raw material, purification, virus inactivation, and QC requirements
- Covers purity analysis, charge heterogeneity, and storage/transport conditions
- Appendices provide raw material, equipment, and QC method guidance
- Drafting Instructions outline document structure and note future updates based on stakeholder input
- Feedback Form collects organizational details and proposed revisions
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