Since the review reform was carried out in 2015, the State Food and drug administration has reviewed and approved 95 innovative drugs and 155 innovative medical devices. Five novel coronavirus vaccines were approved for conditional marketing, two novel coronavirus vaccines were approved for emergency use, and 34 vaccine varieties from five technical routes were approved for clinical trials. 106 novel coronavirus detection reagents were approved, including 38 nucleic acid detection reagents, 37 antibody detection reagents and 31 antigen detection reagents. "The quality of registration application materials is not high, which needs to be supplemented and improved many times in the review process, which seriously affects the efficiency of review and approval; repeated construction and repeated application of generic drugs, vicious competition in the market, and there is a large gap between the quality of some generic drugs and the international advanced level; the listing approval time of clinically urgently needed new drugs is too long, and drug R & D institutions and scientific researchers cannot apply for drug registration, which affects the enthusiasm of drug innovation." This is an honest and sharp analysis of the problems of drugs and medical devices related to people's life and health in a State Council document seven years ago. This analysis resonates with the confusion of ordinary people: Why are some drugs on the market at home "half a beat slower" than those abroad? Why do some people go overseas to buy drugs? The full name of the State Council document is "opinions on reforming the review and approval system of drugs and medical devices", which was printed and distributed in August 2015, thus opening the prelude to the reform of the review and approval system of drugs and medical devices in China (hereinafter referred to as the review reform). In particular, since its establishment in 2018, the State Food and drug administration has continuously deepened the review reform, encouraged the innovation of drugs and medical devices, improved the quality of drugs and medical devices, increased effective supply, and effectively guaranteed the health and life safety of the people. 1. The backlog of registration applications was resolved The quality of drugs and medical devices is related to everyone's health and safety, which is the original intention of implementing the review and approval system. However, if the review efficiency is too low, resulting in the delay of product launch time, it will also affect people's health and safety. After all, disease doesn't wait. Taking drugs as an example, the backlog of drug registration applications in China has been serious in the past period, with a maximum of 22000 applications. Many drugs wait years for approval after they apply for registration. Pharmaceutical companies are helpless and patients suffer. How to speed up the review? This is the first problem to be solved in the reform. The drug regulatory authorities have launched a series of effective measures—— Fully implement the implied licensing system for drug clinical trials that expires within 60 days, which is one third shorter than the 90 day review time limit before the reform. Establish and improve the drug registration procedures, optimize the review and approval process, give priority to the review of drugs in short supply, anticancer drugs, drugs for children, drugs for rare diseases, drugs for major infectious diseases, vaccines in urgent need of disease prevention and control, and innovative high-end medical devices, so as to greatly shorten the review time limit. For drugs with curative effect shown in early clinical trials, they can be approved for marketing with conditions and used in urgent patients who can't wait any longer. ………… As a drug technical evaluation institution, the drug evaluation center of the State Food and drug administration has also strengthened the management of evaluation projects, refined the evaluation sequence, strengthened the time limit management, established a special team, increased the number of reviewers, prepared and revised the key points of evaluation, standardized technical requirements, etc. The evaluation standards, quality and efficiency of drugs have been greatly improved. "From the peak in 2015, there was a backlog of more than 20000 applications, and from 2018, more than 90% of them were reviewed according to the time limit, and China's drug review and approval entered the fast lane." The relevant person in charge of the drug registration department of the State Food and Drug Administration told reporters that, for example, in terms of clinical urgent need of overseas listed new drugs, 51 clinical urgent need of overseas new drugs had been approved by the end of 2021, of which rare disease drugs had been reviewed within 3 months and other clinical urgent need drugs had been reviewed within 6 months, greatly shortening the time for clinical urgent need of overseas new drugs to be listed in China. 2. The innovation enthusiasm of the pharmaceutical industry has been stimulated The backlog of applications has been solved and the speed of drug listing has been accelerated. However, in order to meet the drug needs of the people, new drugs still need to be on the market. Encouraging drug innovation is the core of the review reform. The opinions on reforming the review and approval system of drugs and medical devices issued in 2015 raised the drug approval standards and adjusted the new drugs from "drugs not marketed in China" to "drugs not marketed in China and abroad", that is, "global new drugs". Two years later, the general office of the CPC Central Committee and the general office of the State Council issued the opinions on deepening the reform of the review and approval system and encouraging the innovation of drugs and medical devices, making special arrangements for the innovation of drugs and medical devices. The reporter learned that in order to encourage the research and development of innovative drugs and medical devices, the State Food and drug administration not only gives support in priority evaluation, but also formulates a series of technical guiding principles such as "technical requirements for pharmaceutical common problems of phase I clinical trial application of chemical innovative drugs" to guide the research and development application of innovative products. Reviewers will also actively communicate with R & D and production parties in key review links such as pre clinical, in clinical and before applying for listing, so as to avoid detours. "The review reform encourages clinical value oriented drug innovation, optimizes the review and approval procedures of innovative drugs, and speeds up the review of innovative drugs urgently needed in clinic, which has greatly stimulated the R & D vitality of pharmaceutical enterprises." The person in charge of humanwell Pharmaceutical Group Co., Ltd. told reporters that in recent years, many new drugs have been approved for listing, and the innovation ability has achieved new breakthroughs. Among many reform measures, the drug listing license holder system deserves attention. Previously, only drug manufacturers could apply for registration of drugs. To register drugs, scientific researchers and research institutions must first invest and build factories themselves. This kind of management system, which combines product registration with production license, is not conducive to drug innovation. In 2015, China launched the pilot of drug marketing license holder system in 10 provinces and cities, and drug R & D institutions and scientific researchers can apply for registered drugs. Expert analysis pointed out that this has reduced the capital investment and time cost of drug developers, and the listing of new drugs can be three to five years in advance. In 2019, the drug marketing license holder system was written into the newly revised Drug Administration Law and fully implemented throughout the country. According to the State Food and drug administration, the development of innovative drugs in China has made great progress in recent years. From 2018 to 2021, the number of innovative drugs approved for marketing increased year by year, 11, 12, 20 and 45 respectively, including novel coronavirus vaccines and urgently needed clinical drugs in the fields of tumor, immune system diseases and rare diseases. The pace of medical device innovation is also accelerating. 35 innovative medical devices were approved for listing in 2021, which is the year with the largest number of innovative products approved in recent years. 3. Consistency evaluation to improve the efficacy of generic drugs In recent years, many originally expensive drugs have begun to reduce prices. Careful observation shows that there is a "hero" - generic drugs behind the decline in drug prices. Innovative drugs provide new choices for treating diseases and saving people, but for the vast majority of patients, generic drugs are their life. According to the State Food and drug administration, China's modern pharmaceutical industry started late, and drug production is mainly imitation. More than 95% of the chemical drugs approved for listing are generic drugs. Generic drugs are the imitation of the original drugs after the expiration of the patent protection period, and the price is far lower than that of the original drugs. In the past, the evaluation and approval standard of generic drugs in China was not high, and there was a lack of high-quality generic drugs, and the curative effect was very different from the original drug. Improving the quality and efficacy of generic drugs is an important goal of the review and reform. The solution is to evaluate the consistency of the quality and efficacy of generic drugs - the generic drugs that have been approved for listing are evaluated according to the principle of consistency with the quality and efficacy of the original drug. The core is that the quality and efficacy of generic drugs need to be consistent with the original drug, and can replace the original drug clinically. "There are several key issues in carrying out consistency evaluation. The first is the selection and determination of reference preparations, the second is the determination of technical standards, and the third is to do it in strict accordance with procedures." According to the relevant person in charge of the State Food and drug administration, the Bureau ensured the smooth implementation of the conformity evaluation of generic drugs by improving the evaluation system, strict evaluation standards, strengthening service guidance and optimizing work processes. At present, 4677 product specifications have been published in the catalogue of generic reference preparations, 2044 product specifications and 437 varieties have been applied for through consistency evaluation. Consistency evaluation puts generic drugs on the right track, and ultimately benefits the people. Since the pilot of centralized drug procurement and use organized by the state was launched nationwide in 2019, a number of domestic generic drugs have won the bid. Medical insurance, health care and other departments have organized medical institutions to carry out research on the 14 representative generic drugs that won the bid, which confirmed that the 14 generic drugs that passed the consistency evaluation are clinically equivalent to the original drug. Under the pressure of price reduction, the price of generic drugs is more consistent with that of original drugs, which not only greatly reduces the burden of patients, but also greatly reduces the price of generic drugs. 4. Emergency review and approval provide strong guarantee for epidemic prevention and control 4 days, which is the time for China to complete the review and approval of the world's first novel coronavirus nucleic acid detection reagent and sequencing reagent. On January 20, 2020, the device center of the State Food and drug administration started the emergency work overnight. The reviewers docked with the enterprises one by one all night, and the review and R & D were carried out simultaneously. On January 26, the first batch of four in vitro diagnostic reagent products were approved for marketing, providing effective detection means for the front-line of anti epidemic. The outbreak of COVID-19 poses a challenge to the review reform. Xu Jinghe, deputy director of the State Food and drug administration, said at the Boao Forum for Asia in 2021 that the role of the drug regulatory department in epidemic prevention and control has changed from reviewers to instructors to study with enterprises and speed up the listing of products. It is understood that the State Food and drug administration fully carried out emergency review and approval during the epidemic period. Five novel coronavirus vaccines have been approved for conditional marketing, two novel coronavirus vaccines have been approved for emergency use, and 34 vaccine varieties from five technical routes have entered clinical trials. It organized the formulation of 3 technical guidelines for the research and development of novel coronavirus therapeutic drugs, approved 58 clinical trial applications for novel coronavirus therapeutic drugs, and approved the registration and listing of Qingfei Paidu granules, Huashi Baidu granules and Xuanfei Baidu granules. 106 novel coronavirus detection reagents were approved to effectively meet the needs of epidemic prevention and control. The epidemic is not over yet, and the emergency review and approval are still continuing. As long as people's health needs, the review reform will not stop. Drug administration departments and reviewers are constantly speeding up on the road to a healthy China and accelerating the people's health. (outlook new era)