##  [China: Draft Guidelines for Manufacturing & Testing of Recombinant Monoclonal Antibody Biopharmaceuticals Open for Public Comment](/index%2ephp/mandate/china-draft-guidelines-for-manufacturing-testing-of-recombinant-monoclonal-antibody-biopharmaceuticals-open-for-public-comment) 

November 10, 2025

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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Source

<https://www.cde.org.cn/main/news/viewInfoCommon/669b709bdd86f18e06732111f00a7a8d>

 

 

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