On April 2, 2026, the NMPA issued the Implementation Opinions on "Artificial Intelligence+ Drug Regulation" (hereinafter referred to as the Opinions).

　　The Opinions consist of four parts: general requirements, key regulatory scenarios empowered by digital intelligence, foundational support for "AI + Drug Regulation", and organizational implementation. Focusing on key tasks of drug regulation reform, the Opinions put forward seven key directions for the next stage of regulatory digital intelligence with the goal of modernizing drug regulation. In response to the new trends in AI technology development, it outlines five key tasks to consolidate the foundational support for "AI + Drug Regulation".

　　The Opinions stipulate that by 2030, a preliminary integrated innovation system of AI + drug regulation will be established. The operation and management mechanism of "AI + Drug Regulation" will be basically formed, the computing power support infrastructure will become more integrated and efficient, and high-quality data sets, vertical large models, and intelligent agents that meet regulatory intelligence needs will be developed. Artificial intelligence will be effectively applied in various scenarios such as evaluation and approval, supervision and inspection, testing and surveillance, and government services. The efficiency of human-machine collaboration will be significantly enhanced, and digital intelligence-driven regulatory capabilities throughout the whole lifecycle will reach new heights. By 2035, a new pattern of smart drug safety governance driven by digital intelligence, autonomous control, and ecological collaboration will be basically formed.

　　The issuance of the Opinions is an important measure by the NMPA to implement the decisions and plans of the Party Central Committee and the State Council on comprehensively deepening reform and advancing the "AI +" initiative. It will effectively promote the innovative application of artificial intelligence in the whole lifecycle regulation of "drugs, medical devices, and cosmetics," injecting strong impetus into safeguarding public medication safety and promote the high-quality development of the pharmaceutical industry.

　　(April 2, 2026)