On June 6th, the General Office of the State Council issued the "Key Work Tasks for Deepening the Reform of the Medical and Health System in 2024" (hereinafter referred to as the "Key Work Tasks"), proposing to deepen the reform and innovation in the pharmaceutical field, formulate guiding documents on supporting the development of innovative drugs throughout the entire chain, accelerate the review and approval of innovative drugs, rare disease treatment drugs, clinically urgent drugs, as well as innovative medical devices and epidemic prevention and control drugs.
The Key Work Tasks propose that 2024 marks the 75th anniversary of the founding of the People's Republic of China and is a crucial year for achieving the goals and tasks of the 14th Five Year Plan. To deepen the reform of the medical and health system, we must adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 20th National Congress of the Communist Party of China and the decisions and deployments of the Party Central Committee and the State Council, focus on the coordinated development and governance of medical insurance, healthcare, and medicine, promote the high-quality development of the health industry, and improve the sense of gain, happiness, and security of the people. The key tasks include strengthening the organizational leadership of medical reform, promoting the experience of Sanming medical reform, further improving the medical and health service system, promoting the high-quality development of public hospitals, improving the multi-level medical security system, deepening the reform and innovation in the pharmaceutical field, and coordinating the promotion of other key reforms.
The content of "deepening reform and innovation in the pharmaceutical field" includes:
（17） Improve the use and management of drugs. Promote the coordinated connection between the National Essential Medicines List and the National Medical Insurance Drug List, drug procurement, and consistency evaluation of generic drug quality and efficacy, and optimize and adjust the National Essential Medicines List in a timely manner. Research and formulate policy documents on establishing a drug linkage management mechanism for grassroots medical and health institutions. Intensify the comprehensive clinical evaluation of innovative drugs and promote the rational application of new drugs.
（18） Deepen the reform of the drug review and approval system. Develop guiding documents on supporting the development of innovative drugs throughout the entire chain. Accelerate the review and approval of innovative drugs, rare disease treatment drugs, clinically urgent drugs, as well as innovative medical devices and epidemic prevention and control drugs. Develop and release the fifth batch of encouraged research and development applications for children's drugs and the fourth batch of encouraged generic drug catalogs. Establish a sound evidence system for the evaluation of traditional Chinese medicine, accelerate the review and approval of ancient classic prescriptions and compound preparations, and promote the transformation of traditional Chinese medicine preparations into new drugs in medical institutions. Support the adjustment and use of qualified medical institution preparations between national regional medical centers and project hospitals.
（19） Improve the mechanism for ensuring drug supply. Build a modern drug distribution system and enhance the ability to ensure drug supply. Improve the reporting mechanism for ensuring supply and stabilizing prices of scarce drugs and implement graded response management measures. Promote the monitoring, early warning, and sharing of information on production reserves, shutdown reports, price anomalies, and circulating inventory of drugs that are prone to shortages. Improve the mechanism for monitoring drug use. Study and improve the mechanism for ensuring the supply of medication for children. Fully implement the unique identification of Class III medical devices (including in vitro diagnostic reagents).