On January 16, 2026, Premier Li Keqiang of the State Council signed and issued the State Council Order No. 828, promulgating the amended Regulations on the Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Regulations"), which came into effect on May 15, 2026. As an important administrative regulation in the field of drug administration, the Regulations, based on the summary of the implementation experience of the Drug Administration Law, further refined the institutional measures and provided a solid legal support for deepening the reform of drug supervision, strengthening the supervision of the entire chain, and promoting China's transition from a big pharmaceutical country to a powerful pharmaceutical country.

Drug safety is directly related to people's health and life, and is a significant issue concerning people's livelihood that the Party Central Committee and the State Council attach great importance to. General Secretary Xi Jinping pointed out that the responsibility for drug safety is heavier than Mount Tai, and we must use the most stringent, the most stringent supervision, the most severe penalties, and the most serious accountability to accelerate the establishment of a scientific and sound drug safety governance system. He urged us to strengthen the of basic research and innovation capabilities, and to firmly grasp the lifeblood of the development of the biopharmaceutical industry in our own hands. In recent years, our country hashered to the path of scientific, legal, international, and modern regulatory development, and has continuously deepened the reform of the entire process of drug supervision. In 2019, the Drug Administration Law was comprehensively revised, and the drug industry has achieved rapid development. At the same time, the industry also faces some new situations and new problems, whichently need to be addressed and resolved at the institutional level. This revision of the "Regulations" focuses on key issues in the development of the industry, closely follows the practical needs regulatory work, and follows the following three general principles: First, adhere to the supremacy of the people and the supremacy of life, strictly implement the "four strictest" for drug safety supervision, and strengthen the supervision of the entire chain; second, strengthen the support for innovation, and promote the high-quality development of the drug industry; third adhere to the problem-oriented approach, and refine and supplement institutional measures targeted. Under the institutional framework established by the Drug Administration Law, the "Regulations" make specific regulations on links of drug research and development, production, operation, use, and supervision and management, to ensure that the institutional design is both dense and simple, effective and practical, and provide targeted and operational guidelines for drug regulatory work.

Enhancing the supply of innovative systems, and stimulating the driving force for industrial development. Innovation is the primary driving force for development also a key support for the transformation of China's pharmaceutical industry from large to strong. In recent years, China's pharmaceutical innovation vitality has been continuously released, with 6 innovative drugs approved in 2025, hitting a new historical high. The Provisions, based on the needs of industrial innovation, have established a full-chain support for innovation, stimulating innovation vitality with institutional benefits. In the research and development stage, it highlights the clinical value-oriented approach, encourages the R&D and creation of new, defines the direction of innovation, and consolidates the foundation of innovation. In the drug registration stage, it optimizes the drug evaluation and approval system, establishes multiple drug marketing approval procedures, such as breakthrough therapy drug procedure, conditional approval procedure, priority evaluation and approval procedure, and special approval procedure, to speed up the drug R&D and registration approval and shorten the drug marketing cycle; given the high risk, long cycle, and large investment of drug innovation and R&D in the field of drugs, it provides a maximum of2 years of market exclusivity for pediatric drugs, a maximum of 7 years for rare drugs, and no more than 6 years of data protection for drugs containing new chemical components which is intended to encourage enterprises to increase their investment in innovation. In the production stage, it allows innovative drugs with special requirements on production technology, facilities and equipment to be commissioned fored production, optimizes resource allocation through specialized division of labor, and helps innovative drugs to quickly enter clinical use. In the drug use stage, it strengthens the support for clinical and use of innovative drugs, and benefits patients faster from innovative achievements.

Tighten supervision chains at every link and build a strong barrier for drug safety. High-level safety is a prerequ for high-quality development. The Regulation focuses on the full-link supervision, focusing on key nodes, and layers of responsibilities are implemented and regulatory measures are refined to build a regulatory system and effectively guard the bottom line of public drug safety. In the research and development stage, it is stipulated that non-clinical safety evaluation research of drugs should be out by institutions that have been qualified, the sponsor of drug clinical trials is required to select drug clinical trial institutions and researchers with capabilities and fulfill the responsibilities of protecting subjects, and preparation requirements for clinical trial drugs are clarified to prevent risks from the source. In the production and operation stages, the main responsibility of the holder of drug marketing license is implemented, is required to establish and improve the drug quality assurance system and the drug警戒 system, to comprehensively assess and verify the impact of changes in the production process on the quality of drugs to regularly carry out post-marketing evaluation, and when the holder of drug marketing license entrusts the production of drugs, it should select qualified drug production enterprises, and fulfill responsibilities of supplier audit, change management in the production process, and drug marketing release, etc. At the same time, the storage and transportation of drugs are strengthened, and the for independent packaging and obvious identification of retail distribution are clarified to ensure the safety of drug distribution. In view of the new business form of online drug sales, the Regulation strengthens responsibility of the third-party platform provider of drug network transactions, which is required to establish and improve the quality management system, set up management departments, equip professional personnel and improve management. In the use stage, the rules for the transfer and use of hospital preparations are refined, the reporting and disposal obligations for suspected adverse drug reactions and suspected adverse drug reaction clustering events clarified to ensure the safety of drug use. At the same time, the Regulations further clarify the inspection measures of the drug regulatory authorities, refine the situations of identifying fake drugs and the of sampling inspection and re-inspection. For illegal acts, a variety of punishment measures such as fines, suspension of production and business, revocation of licenses and restriction of are used comprehensively to increase the strength of punishment and strengthen the deterrence of the law.

The rule of law is a powerful weapon to ensure the safety of drugs and the healthy development of the industry. The promulgation and implementation of Regulations is not only an improvement and upgrade of the drug supervision and governance system, but also a precise empowerment of the development of the drug industry, which will surely play an important role ensuring the high-level safety of drugs, promoting the high-quality development of the industry, and meeting the needs of the people for high-quality drug use, and injecting power into the construction of a healthy China. (Liaoxin News Agency)

(The author, Zhang Hongyang, is the Deputy Director of the Legislative Department III of Ministry of Justice.)