Speed up the reform of new drug approval to solve the public's own health problems

[China Pharmaceutical network industry trends] recently, AstraZeneca, a multinational pharmaceutical company, announced that the application for listing the third generation lung cancer targeted drug Teresa in China has been approved by the State Food and Drug Administration and will be officially listed in China soon The approval of AstraZeneca products also shows the acceleration of new drug review and approval system in China (picture source: Baidu picture) the application and approval of new drugs are mainly divided into two stages: clinical research and production and marketing, followed by post marketing monitoring For a long time, it has become an indisputable fact that the efficiency of the examination and approval of new imported drugs in China is not high In this regard, we are faced with such problems as restricted drug innovation, overstocked drug registration applications, lack of approval personnel, and complex approval links Under the influence of these comprehensive factors, the patients delay treatment or have no medicine, which affects the development of medical and health care in China Some data show that the waiting time for clinical review of domestic imported drugs is 6 to 10 months, and the time for applying for production approval is 20 months fast, and 62 months slow Compared with foreign countries, the approval time lags behind, resulting in the lack of domestic imported new drugs, which inevitably can not meet the needs of patients In addition, the approval process is long, and the domestic innovative drug research and development is difficult to sustain due to human and material resources, investment, etc Since August 2015, the State Council issued the opinions on reforming the review and approval system of pharmaceutical and medical devices, which clearly accelerated the review and approval of innovative drugs, improved the approval of clinical trials of drugs, and then in March 2017, the State Food and Drug Administration issued the relevant matters on adjusting the registration and management of imported drugs (Draft for comments), emphasizing that foreign new drugs should be encouraged to enter China at an earlier stage Clinical trials, encouraging foreign new drugs to be approved and listed in China, and simplifying the approval process have shown that the reform of the approval process is imminent Some policies indicate that, first, to cancel the requirement that drugs for clinical trials should have been registered abroad or have entered the second or third phase of clinical trials; The second is to allow imported new drugs to conduct international multi center drug clinical trials in China as early as possible, and allow imported new drugs to directly apply for registration of drug listing after completing the international multi center drug clinical trials, etc., all of which are aimed at shortening the new drug approval process In my opinion, to accelerate the reform of new drug approval, we should reasonably plan and improve the new drug approval process, such as simplifying the main body of approval, strengthening international cooperation of R & D institutions and sharing medical resources to reduce repeated clinical trials, etc.; secondly, we should increase policy support of enterprises, increase investment in drug research and development, and introduce R & D risk assessment; The third is to speed up the examination and approval of new drugs involving major dangerous diseases or diseases with a large number of diseases In addition, it is worth considering that the quality of drugs is related to our life and health While improving the approval efficiency, we should also grasp the safety bottom line There is a consensus that, while encouraging the early marketing of imported new drugs needed for clinical major diseases, it is necessary to strengthen supervision and establish the evaluation and traceability mechanism for imported new drugs in view of the possible adverse reactions of imported new drugs For example, after the new imported drugs are put on the market, it is necessary to strengthen the re evaluation, trace the quality and safety of the new imported drugs, and order the new imported drugs with serious adverse reactions to withdraw from the market It is not hard to see that how to solve the health problems of the people by accelerating the reform of new drug approval is an important part of the people's sense of gain and one of the means to protect the people's livelihood.