At present, my country's pharmaceutical and medical device industry is developing rapidly, innovation and entrepreneurship are in the ascendant, and the reform of the review and approval system continues to advance. However, on the whole, my country's pharmaceutical and medical device scientific and technological innovation support is insufficient, and the quality of listed products is far from the international advanced level. In order to promote the structural adjustment and technological innovation of the pharmaceutical and medical device industry, improve the competitiveness of the industry, and meet the clinical needs of the public, the following opinions are hereby provided on deepening the reform of the review and approval system to encourage the innovation of pharmaceutical and medical devices.

　　 2. Speed up the listing review and approval

　　 (9) Accelerate the review and approval of clinically urgently needed drugs and medical devices. For the treatment of severely life-threatening diseases with no effective treatment methods, and public health and other urgently needed drugs and medical devices, if the early and mid-term indicators of clinical trials show curative effects and can predict their clinical value, they can be approved for listing with conditions, and enterprises should develop risk management and control Plan and conduct research as required. Encourage the research and development of new drugs and innovative medical devices, and give priority to the review and approval of new drugs and innovative medical devices that are supported by major national science and technology projects and national key research and development plans, as well as new drugs and innovative medical devices that are carried out by the National Clinical Medical Research Center and approved by the central management department.

　　 (10) Support the research and development of drugs and medical devices for the treatment of rare diseases. The National Health and Family Planning Commission may entrust the relevant industry associations (academics) to publish the rare disease catalog and establish a rare disease patient registration system. Applicants for registration of rare disease treatment drugs and medical devices may apply for exemption from clinical trials. For rare disease treatment drugs and medical devices that have been approved for listing abroad, they may be approved for listing with conditions. Enterprises should formulate risk management and control plans and conduct research as required.

　　 (11) Strictly review and approve drug injections. Strictly control the conversion of oral preparations to injection preparations. If oral preparations can meet clinical needs, injection preparations will not be approved for marketing. Strictly control the change of intramuscular injection preparations to intravenous injection preparations. If intramuscular injection preparations can meet clinical needs, intravenous injection preparations will not be approved for marketing. Applications for the mutual modification of dosage forms among large-volume injections, small-volume injections, and sterile powder injections for injection shall not be approved if there is no obvious clinical advantage.

　　 (12) Implementation of related approvals for drugs and pharmaceutical raw materials and packaging materials. APIs, pharmaceutical excipients, and packaging materials are reviewed and approved together when reviewing drug registration applications. API approval numbers will no longer be issued. APIs, pharmaceutical excipients, and packaging materials and their quality standards that have been reviewed and approved by related parties are reviewed and approved. Announce on designated platforms for relevant companies to choose. The holder of the drug marketing authorization is responsible for the quality of the raw materials, pharmaceutical excipients and packaging materials used in the production of the preparation.

　　 (13) Support the inheritance and innovation of Chinese medicine. Establish and improve the registration management system and technical evaluation system in line with the characteristics of traditional Chinese medicine, and handle the relationship between maintaining the traditional advantages of traditional Chinese medicine and the requirements of modern drug research and development. Innovative traditional Chinese medicines should highlight the new characteristics of curative effects; new and improved traditional Chinese medicines should reflect the advantages of clinical application; classic Chinese medicines should be reviewed and approved in accordance with simplified standards; natural medicines should be reviewed and approved in accordance with modern medical standards. To improve the clinical research capabilities of traditional Chinese medicine, the registration application of traditional Chinese medicine needs to submit marketing value and resource evaluation materials, highlighting the clinical value as the orientation, and promoting the sustainable use of resources. Encourage the use of modern science and technology to research and develop traditional Chinese patent medicines, encourage the development of new Chinese medicines based on the advantages of traditional Chinese medicine formulations, and strengthen the quality control of Chinese medicines.

　　 (14) Establish a priority review and approval system for drugs under patent compulsory license. In the case of a major threat to public health, the drug registration application that has obtained a compulsory license will be given priority review and approval. Circumstances in which public health is seriously threatened and the procedures for initiating compulsory licenses shall be stipulated by the National Health and Family Planning Commission and relevant departments.