According to the Beijing Municipal Commission of health and health, the clinical trial process of pharmaceutical enterprises is expected to be shortened

[pharmaceutical network industry trends] clinical trials are the key link of pharmaceutical innovation industry, the method to verify the safety and effectiveness of drugs in human body, and the link to invest more money and time in the process of drug research and development In recent years, the state has intensively issued a series of biomedical development plans and pharmaceutical management reform policies to promote the development of biomedical industry However, the industry points out that the development of China's pharmaceutical innovation clinical trials lags far behind other links of the innovation chain It is urgent to deepen the reform of clinical trials, promote the design and implementation of clinical research system, and strengthen the structure of pharmaceutical innovation ecosystem To speed up the development of innovative drugs The author learned that recently, news came from Beijing that about 20 new demonstration research wards will be built in the city next year, and the clinical trial process of pharmaceutical enterprises is expected to be shortened, which is good news for pharmaceutical enterprises Beijing Municipal Commission of health and Health recently announced that the city plans to take about three years to implement research-oriented ward construction projects in hospitals qualified for clinical trials of drugs and medical devices This year, the city started the standardized construction of research wards throughout the city It plans to pilot the construction of about five demonstration research wards By 2020, about 20 demonstration research wards will be built By 2022, the city's demonstration research ward will cover major disease areas Through the establishment of research ward, it will provide a more favorable business environment for the pharmaceutical enterprises to carry out clinical trials in the future, and help to shorten the clinical trial process of pharmaceutical enterprises "To do clinical trials, we need to contact different hospitals Each hospital has different application texts The ethical review takes a long time It needs to wait for half a year or even a year The long application process of clinical trials will affect the speed of drug development of enterprises In addition, some hospitals do not have enough experimental beds, so enterprises can only wait for clinical trials, and the procedures are cumbersome " For this industry table, we hope to speed up internal review, optimize process, unify application elements template, shorten waiting time in medical institutions in clinical trial stage of enterprises, and accelerate clinical drug trials Beijing's move will better promote the healthy development of Beijing's pharmaceutical industry, "a large number of pharmaceutical enterprises can come here for clinical trials and research, so that new drugs and medical devices can play a better role." Some insiders said Clinical research is an irreplaceable step in the pharmaceutical innovation industry chain It is also a stage with a lot of investment time and resources It is an important link in the whole pharmaceutical innovation ecosystem Only by fast reading and improving the clinical research ability can we grasp the new opportunities for the development of pharmaceutical innovation industry In recent years, the clinical trials in China are also constantly optimized It is reported that as of May 2019, there are 744 drug clinical trial qualification agencies in China The new version of the drug administration law, which will be officially implemented on December 1, also points out that the drug clinical trial institutions implement the filing management, which means that more clinical trial institutions can support the research and development of new drugs
However, some insiders also pointed out that, in fact, due to the lack of previous clinical trial experience and the aggregation effect of medical resources, there are only a limited number of institutions with clinical research ability If a large number of clinical trial institutions do not have rapid and effective cultivation and promotion of their experimental ability, they will still be unable to solve the problem of clinical resource shortage, and those with research ability and experimental experience will still have Institutions are still the resources that enterprises need to compete for
In order to better promote the adaptation of China's clinical trials to the pharmaceutical innovation chain, experts said that in addition to establishing and improving policies and regulations, improving the top-level design, we should also promote the design and implementation of the clinical research system, including the reform of hospital rating and doctor title evaluation methods, the optimization of clinical trial center management and full-time personnel management, the improvement of ethical review system, and the strengthening of clinical research The cultivation of talents and popular science education.