Regulatory Guidance on the Production of Antibody-Drug Conjugates (ADCs) in China

The Center for Drug Evaluation (CDE) has introduced new guidelines to support the segmented production of biological products, particularly focusing on Antibody-Drug Conjugates (ADCs).

The "Technical Requirements for the Registration and Application of Pilot Segmented Production of Antibody-Conjugated Drugs” (November 7, 2024) notice outlines this approach, which distributes different stages of manufacturing across multiple facilities while ensuring quality and regulatory compliance.

Objectives of New Guidelines for ADCs

Segmented production is a strategy aimed at improving efficiency in the Chinese biopharmaceutical industry. However, it presents risks, particularly in the transportation and handling of intermediate products, which can affect stability and efficacy.

The CDE’s guidelines specifically address these risks for ADCs, which are biologics conjugated with small molecules, by adapting international standards like ICH (International Council for Harmonisation). The goal is to standardize the approach to segmented production while maintaining product safety and quality.

Key Regulatory Developments

1) Technical guidance for segmented production

Manufacturers and Marketing Authorization Holders (MAHs) must integrate domestic guidelines with ICH standards to manage risks, focusing on transportation, lifecycle management, and regulatory documentation. Companies are encouraged to establish best practices aligning with both local and global regulations.

2) Risk management

A mandatory risk assessment for transportation, handover, and exchange of intermediate products is required, given the complexity of ADC production. Comprehensive quality control strategies must be developed to address stability concerns, contamination risks, and environmental factors such as temperature and humidity fluctuations.

3) ADC-specific challenges

Due to their sensitivity to environmental factors and complex structure, ADCs require stringent stability and quality controls during segmented production. The guidelines emphasize maintaining product integrity during transportation and handover processes, ensuring that any changes in production sites do not compromise safety and efficacy.

Regulatory Compliance & Best Practices

For compliance and regulatory affairs professionals, key actions to consider include the following:

• Risk-based approach: Ensure that all risks associated with segmented production are properly identified, assessed, and mitigated. This includes addressing potential risks in transportation, handling, and quality control of intermediate products.

• Documentation and justification: MAHs must provide robust documentation that justifies the risk management strategies, particularly in terms of stability studies, handover protocols, and the establishment of acceptance standards.

• Collaboration with regulatory bodies: The CDE encourages ongoing communication between MAHs and regulatory authorities to resolve any technical challenges or uncertainties in the production process.

Conclusion

The CDE’s updated guidelines for segmented production of ADCs aim to enhance regulatory oversight and improve the safety, stability, and quality of biopharmaceutical products in the Chinese market.

Compliance professionals must stay informed about these evolving requirements and implement stringent quality control measures to ensure that ADCs remain effective throughout the segmented production process. By following these guidelines, companies can enhance efficiency while maintaining compliance with international and domestic regulations.

Further Information

Read the original CDE announcement on the Technical Requirements for the Registration and Application of Pilot Segmented Production of Antibody-Conjugated Drugs.

For more information on how these guidelines might impact your development process, contact us to learn about our specialized drug registration and filing services in China.

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