NMPA Issues Implementation Opinions on "Artificial Intelligence + Drug Regulation"

Recently, the National Medical Products Administration (NMPA) has issued the Implementation Opinions on "Artificial Intelligence + Drug Regulation" (the "Opinions").

The Opinions consist of four parts: overall requirements, key regulatory scenarios empowered by digital and intelligent technologies, foundational support for "AI + drug regulation," and organization and implementation. According to the Opinions, by 2030, China aims to preliminarily establish an integrated innovation system for drug regulation and AI, basically form an operational and management framework for "AI + drug regulation," and elevate digital and intelligent regulatory capabilities across the entire lifecycle to a new level. By 2035, a new paradigm of smart drug safety governance—featuring data- and intelligence-driven regulation, agility, independent controllability, and ecosystem-based coordination—will be largely in place. Focusing on key tasks in the reform of drug regulation and aiming at the modernization of drug regulation, the Opinions set out seven priority directions for advancing the digital and intelligent transformation of regulation in the next stage. In addition, in light of emerging trends in AI technologies, the Opinions propose five key tasks to strengthen the foundational support for "AI + drug regulation."



(Source: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjzh/20260402091552114.html)

Note: The link to the Chinese official website of the document is for your reference.