Implementation Regulations of the Drug Administration Law Promulgated
Date:2026-02-10count:
Li Qiang Signs State Council Order Promulgating Revised Implementation Regulations of the Drug Administration Law of the People's Republic of China
Premier Li Qiang of the State Council recently signed a State Council order promulgating the revised "Implementation Regulations of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Regulations"), which will take effect on May 15, 2026. The Regulations comprise nine chapters and 89 articles. The main contents of the revised version are as follows:
First, improving the drug research and registration system. Supporting drug research and innovation oriented toward clinical value, encouraging the research and development of new drugs, and supporting the clinical promotion and use of new drugs. Clarifying the qualification recognition procedures for non-clinical drug safety evaluation research institutions, and refining management requirements for drug clinical trials. Establishing expedited procedures for drug marketing registration, clarifying drug re-registration procedures, and specifying the conversion mechanism between prescription and non-prescription drugs. Granting market exclusivity periods for eligible pediatric drugs and rare disease treatment drugs, and providing data protection for drugs containing new chemical entities. Refining the responsibilities of marketing authorization holders.
Second, strengthening drug production management. Strictly managing entrusted drug production, solidifying the responsibilities of marketing authorization holders during entrusted production, and clarifying circumstances under which segmented drug production may be entrusted. Specifying management requirements for the production and sale of traditional Chinese medicine decoctions and traditional Chinese medicine formula granules.
Third, standardizing drug distribution and use. Improving the drug online sales management system, solidifying the responsibilities of third-party platform providers for online drug transactions. Strengthening pharmaceutical administration in medical institutions to ensure drug quality during the usage phase. Clarifying the approval procedures for medical institution preparations, specifying the conditions and procedures for the adjustment use of medical institution preparations, and supporting the preparation of pediatric medical institution preparations to meet the medication needs of pediatric patients.
Fourth, strictly supervising drug safety. Clarifying measures for drug safety supervision and inspection. Refining procedures for drug quality sampling and inspection, specifying that parties may apply for re-inspection if they object to inspection results. Establishing strict legal liabilities for violations.
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