On April 2, the National Medical Products Administration (NMPA) issued the Implementation Opinions on “Artificial Intelligence + Drug Regulation”. Together with the full implementation of eCTD (Electronic Common Technical Document) submissions starting in March this year, the policy forms a coordinated package, accelerating the intelligent upgrade of China’s drug registration review and whole lifecycle regulation.
As a standardized digital carrier for drug registration applications, eCTD has established a structured and interactive regulatory data infrastructure. The seven key digital regulatory scenarios and five core support tasks outlined in the Implementation Opinions effectively equip eCTD with an “intelligent brain”. On one hand, artificial intelligence will deeply empower intelligent pre-review, format validation, data comparison, and risk mining of eCTD dossiers, significantly reducing manual review costs, shortening review cycles, and improving application quality. On the other hand, the massive standardized registration data accumulated through eCTD will serve as core resources for training vertical large models for drug regulation and building high-quality datasets, in turn fueling the continuous advancement of AI-enabled regulatory capabilities.
The release of the Implementation Opinions represents not only an upgrade in regulatory technology but also an innovation in regulatory logic. It marks a shift from traditional paper-based review and manual judgment to a modern governance model driven by data, human-machine collaboration, and intelligent early warning. This initiative is expected to notably improve the efficiency and accuracy of review, approval, and regulation for drugs, medical devices, and cosmetics, accelerate the alignment of China’s pharmaceutical regulation with international standards, and solidify a digital foundation for safeguarding public drug safety and promoting the high-quality development of the pharmaceutical industry.
Attachment: Implementation Opinions of the National Medical Products Administration on “Artificial Intelligence + Drug Regulation”
https://www.gov.cn/zhengce/zhengceku/202604/content_7064591.htm