The Regulations on the Implementation of the Drug Administration Law will be comprehensively revised for the first time in 23 years and will come into effect on May 15th.

Premier Li Keqiang of the State Council recently signed the State Council Order to promulgate the revised Regulations on the Implementation of the Drug Administration Law of the People's Republic of China, which will come into effect on May 15, 2026. The Regulations consist of 9 chapters and 89 articles, with the following main revisions. Firstly, improvements have been made to the drug development and registration system. Support is provided for drug development and innovation based on clinical value, and efforts are encouraged in research and development of new drugs, as well as supporting the clinical promotion and use of new drugs. The qualifications for assessing the non-clinical safety of drugs have been clarified, and the requirements for managing drug clinical trials have been detailed. A fast-track registration program for drug market entry has been established, and procedures for re-registration of drugs have been specified, along with regulations on the mechanism for switching prescription and non-prescription drugs. Market exclusivity will be granted to drugs for pediatric use and drugs for rare disease treatment that meet the criteria, as well as data protection for drugs containing new chemical components. The responsibilities of drug marketing authorization holders have been further detailed. Secondly, drug production management is being strengthened. Strict management of drug contract manufacturing will be enforced, with the responsibilities of the marketing authorization holder during contract manufacturing being emphasized, and circumstances under which drug production can be segmented will be specified. Requirements for the production and sale of traditional Chinese medicine decoction pieces and granules will be clarified. Thirdly, drug distribution and use will be standardized. Improvements will be made to the management system for online drug sales, with responsibilities of third-party platforms in online drug transactions being emphasized. Drug management in medical institutions will be strengthened to ensure the quality of drugs used in treatment. The approval process for the preparation of drugs in medical institutions will be clarified, and conditions and procedures for the dispensing of preparations in medical institutions will be specified, with support provided for the preparation of pediatric drugs in medical institutions to meet the needs of pediatric patients. Fourthly, strict drug safety supervision will be enforced. Measures for drug safety supervision and inspection will be clarified. The process for quality sampling and testing of drugs will be detailed, and parties with objections to inspection results will be able to request retesting. Strict legal responsibilities will be established for violations.