Li Qiang signs the State Council order to announce the revised Implementation Regulations of the Drug Administration Law of the People's Republic of China-瞭望新时代网

Li Qiang signs the State Council order to announce the revised Implementation Regulations of the Drug Administration Law of the People's Republic of China

2026-01-28

Premier Li Qiang of the State Council recently signed the State Council order, announcing the implementation of the amended "ulations on the Implementation of the Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Regulations"), which will be implemented May 15, 2026. The "Regulations" consist of 9 chapters and 89 articles, and the main content of the revision is as. Firstly, the system of drug research and registration is improved. Support is provided for drug research and innovation oriented by clinical value, and research and creation of new drugs encouraged. Support is provided for the clinical promotion and use of new drugs. The qualification recognition procedure for non-clinical safety evaluation research institutions of drugs is clarified, and the for drug clinical trial management are refined. A procedure for accelerating the registration of drug listing is established, the procedure for re-registering drugs is clarified, and the conversion mechanism for drugs and non-prescription drugs is stipulated. Market exclusivity is granted to children's drugs and drugs for the treatment of rare diseases that meet the conditions, and data is provided for drugs containing new chemical components, etc. Responsibilities of drug marketing license holders are detailed. Secondly, the management of drug production is strengthened. The management entrusted drug production is strictly enforced, and the responsibilities of the drug marketing license holder at the time of entrusted production are implemented. It is clarified that the production of drugs be entrusted to be produced in sections under certain circumstances. The management requirements for the production and sale of traditional Chinese medicine decoction pieces and traditional Chinese medicine formula particles are clarified Thirdly, the management of drug operation and use is standardized. The management system of online drug sales is improved, and the responsibility of the third-party platform provider online drug transactions is implemented. The drug administration of medical institutions is strengthened to ensure the quality of drugs in the use process. The approval process for medical institutions to prepare pharmaceutical preparations is, and the conditions and procedures for the transfer and use of medical institution preparations are stipulated. Support is provided for the preparation of pharmaceutical preparations for children's use in medical to meet the medication needs of pediatric patients. Fourthly, the supervision of drug safety is strictly enforced. Measures for drug safety supervision and inspection are clarified. The of drug quality spot checks is refined, and it is stipulated that parties who have objections to the inspection results can apply for a re-inspection. Strict legal responsibilities set up for illegal acts. (Liaoxin News Agency)

Edit：Chenjie Responsible editor：Jiajia

Source：legaldaily

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