China NMPA Proposes Updated Technical Requirements for Drug Traceability Systems

On August 3, 2026, the Information Center of the National Medical Products Administration released an official notice seeking public feedback on the revised standard titled "Basic Technical Requirements for Drug Traceability System (Revised Draft for Comments)." 

The revised draft sets out technical requirements for the construction and use of drug traceability systems, covering Marketing Authorization Holders (MAHs), manufacturers, distributors, healthcare institutions, and technical service providers participating in China’s drug traceability framework.

The public consultation window is open through September 3, 2026.

Proposed Technical Requirements

The revised draft addresses full-process traceability, system interoperability, data management, information security, and system operation.

End-to-End Tracking & System Integration

• Requires traceability systems to cover traceability information throughout drug production, distribution and use.
• Requires connectivity with the drug traceability harmonization service platform and drug traceability regulatory systems to support data filing, reporting, exchange and queries.
• Encourages deeper integration of drug traceability systems with enterprise systems such as Enterprise Resource Planning (ERP), Warehouse Management Systems (WMS), Supply Chain Management (SCM) systems and Hospital Information Systems (HIS) to improve data exchange, management efficiency and compliance.
•  Sets functional requirements covering basic data management, drug traceability code management, inbound and outbound traceability information, returns and recall-related traceability functions.

Data Ownership & Authorization Protocols

• Establishes the principle that traceability data permissions should be managed according to “whoever generates the data owns it”. Requires authorization and permission-management functions, including for logistics activities and access by authorized MAHs to relevant distribution and use data.
• Requires mechanisms for secure traceability-data exchange and authorized use un accordnace with applicable data-security requirements.

MLPS Level 3 Security & Access Controls

• Requires drug traceability systems to meet MLPS Level 3 information-system security requirements. (MLPS Level 3)
• Requires multi-factor authentication (MFA) and role-based access controls following the principle of least privilege.
• Requires regular data-security risk self-assessment and encourages periodic third-party data-security risk assessments.

Infrastructure, Storage & Backup Protocols

• Requires system availability and fault tolerance capabilities, including support for multiple parallel instances and recovery where an individual instance fails.
• Requires storage capabilities for structured, semi-structured and unstructured data.
• Requires defined data-backup strategies and system emergency-response arrangements to support stable operation and timely response to failures.

Traceability Queries & Regulatory Data Exchange

• The draft requires drug traceability systems to support traceability-information queries and connectivity with regulatory traceability systems, enabling required regulatory data exchange and access to relevant traceability information.

Traceability Code Controls

The revised draft strengthens controls over drug traceability codes. Systems should identify and warn users when uploaded data contain traceability codes that have already been activated. Repeated activation is generally prohibited, with exceptional cases requiring supporting explanations and legally valid documentation, together with records of the handling process.

Support Submitting Your Comments

The consultation remains open until September 3, 2026. Companies operating drug traceability systems in China should review the proposed requirements against their current system architecture, security controls and data-management processes and consider whether any provisions warrant consultation feedback.

Contact Cisema to discuss how the proposed requirements may affect your operations in China.

Further Information

• Explore Cisema’s pharmaceutical consulting services for China.

References

• Notice on Public Solicitation of Opinions on the 'Basic Technical Requirements for Drug Traceability Systems (Revised Draft for Comments)'