NMPA Issued Plan for Cybersecurity in Drug Supervision

On April 24, 2022, NMPA issued the "14th Five-Year Plan for Cybersecurity and Informatization Construction in Drug Supervision" (“Plan”), which clearly aims to support drug safety and high-quality development and improve the modernization of drug supervision.

The Plan highlights the construction requirements of drug approval, inspection, monitoring, evaluation, information traceability, professional team building, Internet + integration, etc., and takes drug supervision capacity and information construction as important content.

In terms of drug regulatory capacity building, the Plan proposes to deeply integrate drug approval and filing, information collection businesses, continuously improve the construction of drug business application systems, and realize drug approval and filing, production licenses, annual reports, production supervision inspections, and collection of administrative punishment information, etc. "One-stop" business reporting, supervision and inquiry.

In terms of the construction of the information traceability system, the Plan proposes to establish and improve the drug traceability system, expand the construction of the drug traceability collaborative service platform and traceability supervision system, and gradually realize the retrospective supervision of key varieties such as narcotic drugs, psychotropic drugs, blood products, and the varieties selected by the national organization for centralized procurement.

In terms of drug safety risk and credit, create drug safety credit files, and collect relevant information including drug production licenses, daily supervision and inspection results, investigation and punishment of illegal acts, random inspections of drug quality, records of bad behavior, complaints and reports.

The Plan also proposes 4 safeguard measures to strengthen and improve drug supervision and information management, requiring regulatory authorities at all levels to play a leading role, clarify responsibilities, establish project supervision and inspection procedures, and formulate performance evaluation indicators to promote work implementation.