Four acceleration channels will be set up, including special examination and approval

[policies and regulations of pharmaceutical network] the speed of drug approval is accelerating, and China's pharmaceutical market is undergoing a reshuffle It is understood that on December 10, the State Administration of Market Supervision issued a public notice on the measures for the administration of drug registration (Draft for comments) (hereinafter referred to as the "measures for registration") for opinions, and the feedback of opinions is up to December 17, 2019 It is understood that the registration measures make specific arrangements to improve the efficiency of drug registration, clarify the responsibilities of various departments in drug registration management, do a good job in the connection of drug registration acceptance, review, inspection and inspection, and improve the efficiency of drug registration and the expectation of registration time limit According to the registration measures, the State Food and Drug Administration will establish a registration system to accelerate the listing of drugs and support drug innovation oriented by clinical value For qualified drug registration applications, the applicant may apply for entry into breakthrough treatment drugs, conditional approval, priority review and approval, and special approval procedures According to the document, four acceleration channels will be set up: breakthrough treatment drugs, conditional approval, priority review and approval, and special approval The scope, procedures and supporting policies of each channel shall be specified In terms of the review, the registration measures put forward the working time limit It is required that the time limit for the application review of drug listing license is 200 working days, of which the time limit for the review of the priority review and approval procedure is 130 working days, and the time limit for the review and approval procedure of the priority review and approval procedure of drugs for rare diseases that are urgently needed to be listed abroad is 70 working days In addition, the time limit for the independent application for the review of generic domestic listed drug APIs is 200 working days In terms of generic names of drugs, the time limit for approval of the draft is 30 working days The time limit for the suitability review of over-the-counter drugs is 30 working days In the registration method, the original review, verification and inspection were changed from "series" to "parallel", and all links began to review simultaneously, which will be more obvious for the improvement of review and approval speed It is understood that since the reform of drug review in China, the speed of drug review and approval has increased significantly For example, the approval time of new anticancer drugs in China has been shortened by half, the average time is about 12 months, which is in line with the approval speed of developed countries In recent years, the reform of China's drug review and approval system has been deepened, the "life-saving drugs" priority review and approval policy has been continuously improved and implemented, and the whole regulatory process has been greatly accelerated, which makes the number of innovative drugs listed in China continue to rise, and also attracts major pharmaceutical companies around the world to continuously increase investment in R & D and innovation in China Novartis, a Swiss pharmaceutical company, plans to submit 50 new drug applications in China in the next few years, foreign media reported The company expects China's faster approval of new drugs, which could make it the second-largest market, ahead of Europe Sanofi, a French pharmaceutical company, has opened an Asian Research and development center in Chengdu The company will invest 66 million euros in the southwestern city of China to study a range of diseases, including diabetes and immune diseases The reform of drug review and approval system in China is "fast, strict and excellent", and new achievements have been made in promoting the reform of drug review and approval system as a whole The quality of drugs has been steadily improved In addition, the policy of encouraging innovation represented by the pilot of holder system has greatly aroused the enthusiasm of scientific research institutions and researchers, enhanced the endogenous power of new drug creation, and further stimulated the vitality of R & D and innovation This registration method proposes to set up four acceleration channels: breakthrough treatment drugs, conditional approval, priority review and approval, and special approval This will bring good news for drug review and approval in China "In fact, it is mainly to improve the approval efficiency and speed up the approval speed, which is not only beneficial to small companies, but also to large companies to speed up the listing of new drugs It used to be a step-by-step audit, but now it's parallel, that is to say, all links start to review synchronously In addition, it also puts forward that we should pay attention to the post supervision and further clarify the requirements that the corresponding work must be completed after the conditional approval of drug listing It can be seen that on the one hand, it is to liberalize and on the other hand, it is to strengthen the supervision " Some insiders said.