China’s National Medical Products Administration (NMPA) has unveiled the “Three-Year Action Plan for Smart Supervision of Blood Product Production (2024-2026),” with a strategic focus on enhancing the digital management of blood product manufacturers. The initiative aims to elevate the supervision of blood products and ensure their high quality and safety by the close of 2026.
Key objectives of the plan include:
- Enhancing Plasma Reception Information Management: Manufacturers are required to develop information systems that electronically document the plasma reception and acceptance process. Integration with the information systems of individual plasma collection stations will ensure traceability for each plasma sample.
- Fortifying Production Process Information Management: Companies must implement automated and digital methods for data collection and real-time monitoring of critical equipment during key production stages. Video data collection will be necessary for visual management of human-computer interaction processes.
- Boosting Testing Phase Information Management: The plan involves the use of an information system to manage electronic batch inspection records, stability assessments, and other testing processes. An electronic record management system will be established for standard/reference materials, reagents, and test solutions, with the system capable of automatically determining if inspection results surpass predefined quality thresholds.
- Ensuring Compliance and Security of Information Management Systems: Information systems and data security must align with the standards of network security level protection. The plan calls for data retention, audit tracking, and backup measures to ensure data recoverability.
As outlined in the document, the targeted completion rates for the initial implementation phase (June-December 2024) and the continuous promotion phase (January-December 2025) are approximately 30% and 60%, respectively. In the final stage (January-December 2026), each provincial-level drug supervision and management department is tasked with comprehensively reviewing the progress of intelligent supervision within their jurisdiction, compiling a report, and submitting it to the national bureau.- Flcube.com
