In the past, drug regulations and policies belonged to the research category of drug management. From about 2006, scholars began to study drug regulation from the perspective of administration and politics. I was lucky to be a member of the academic community. At that time, many drug safety incidents occurred one after another, drug evaluation and falsely high drug prices were also widely reported, and the social response was strong. We have gradually reached a consensus in our research - drug safety is produced and supervised, and a strong industrial foundation is very important. However, it is not easy. The large number, small scale and weak innovation ability of Chinese pharmaceutical enterprises are historically formed. These problems are intertwined with local economy and hospital income, so it is very difficult to solve them. In 2012, I specially wrote an academic paper, proposing that drug evaluation is directly related to what enterprises can produce, what hospitals can enter, what patients can use and what medical insurance can report. Therefore, the interests and contradictions are highly concentrated, and the reform is very difficult. The turning point occurred in August 2015, when the State Council issued the opinions on reforming the evaluation and approval system of drugs and medical devices. Before and after this, regulatory authorities, industry, experts and scholars conducted in-depth discussions, and I also attended some meetings. I still keep a picture in the computer, which is the analysis of the review time lag by the drug review organization, subdivide each link, accurate to the number of days, and put forward targeted countermeasures. Everyone has the same goal to make patients eat safer and more effective drugs. According to my understanding, the initial reform is to solve the backlog of registration and improve the standards of new drugs and generic drugs. Therefore, the main measures at that time were to crack down on data fraud, simplify review procedures and increase technical force. I have communicated with many people in the industry. Our common feeling is that through resettlement, enterprises have stable expectations, dare to invest in R & D, and the information between the sponsor and the regulator is more symmetrical. After 2016, the reform further clarified the idea of encouraging innovation and introduced relevant systems. This leap from "keeping the bottom line" to "striving for high line" has been widely praised. I remember at a forum, a person in charge of a pharmaceutical enterprise said excitedly that "everyone loves the drug trial reform", and the whole audience applauded for a long time. I think this is the market's praise for the promising government. Personally witnessing this reform, I have a feeling that the courageous reformers have grasped the pulse of the new era and have done something they wanted to do but failed to do in the past. It is believed that this review reform aimed at giving birth to more safe and effective drugs will eventually benefit every patient. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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