The speed of review and approval has been increasing year by year, and the number of innovative drugs in China will continue to rise

[industry trends of pharmaceutical network] the continuous improvement of review and approval speed has brought many benefits to the pharmaceutical industry The industry said that with the continuous acceleration of new drug approval, China's pharmaceutical market will experience a shuffle! The speed of review and approval has been increasing year by year (photo source: pharma Com) In recent years, the reform of drug review and approval system in China has been deepening 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 According to the drug review report issued by the drug review center every year, in 2016, the drug review center accepted 77 domestic innovative drug registration applications, increased to 112 varieties in 2017, and increased 3 varieties in 2018, with the number reaching 115 In addition to 115 varieties of domestic innovative drugs, the center also accepted one variety of domestic innovative drugs and 106 varieties of biological products in the same year Compared with 2017, in 2018, the number of applications for clinical trials (ind) of class 1 innovative drugs increased by 15%, and the number of applications for new drug listing (NDA) increased by 150% The change of the number of applications fully reflects that the innovation enthusiasm of all kinds of subjects in China is increasing year by year "It sometimes takes more than ten years for a new drug to be approved for clinical use to be put on the market The payback period for the enterprise is only a few years We've invested a lot of time and money to make a new drug, but the return is not even as good as making generic drugs The acceleration of approval means that the payback period for us is longer " Some insiders said that if the review and approval time is shortened, the new drugs will be put on the market faster, and the enterprises can see the benefits as soon as possible and invest in the next round of R & D, which can not only improve the R & D power and strength of the enterprises, but also meet the drug demand of patients, forming a virtuous circle of the drug market Safety and effectiveness are the basic requirements for drugs, which is also the original intention of drug review and approval However, in the past, the problems of low efficiency of drug examination and slow drug listing have puzzled the pharmaceutical enterprises Many drugs wait years to be approved after they have applied for registration The backlog of drug registration applications is serious But in recent years, with the national review and approval speed increasing year by year, this phenomenon has been greatly alleviated It is understood that China has improved the technical support system for drug review and approval Initially formed a review mechanism focusing on the construction of the indication team and project management, prioritizing review, communication and exchange, expert advisory committee and seamless connection of information disclosure The number of drug review teams increased from less than 200 to more than 800, and the standards, quality and efficiency of drug review have been greatly improved Nowadays, the direction of encouraging drug R & D innovation in drug trial reform is more and more obvious "For example, the implementation of the marketing license holder system has reduced the capital investment and time cost of drug developers, and the time of new drug marketing has been reduced by about three to five years." In addition, the establishment of priority review and approval system saves more time and cost for new drug research and development Some industry people said Under the joint action of policy encouragement and market promotion, China has stepped into a solid step from a big country of generic drugs to a big country of innovative drugs For example, traditional leading pharmaceutical companies such as Hengrui pharmaceutical, Zhengda Tianqing, Fosun Pharmaceutical, and Shiyao group have also arranged research and development of innovative drugs in advance For example, Hengrui pharmaceutical has invested 2.67 billion yuan in research and development in 2018, accounting for more than 15% of sales revenue It is worth noting that although China's innovative drugs have been greatly developed, compared with developed countries, there is still a large gap in the level of drug research and development in China, with more follow-up research and development, and relatively lack of breakthrough innovation In this regard, China needs to continue to introduce a series of policies, deepen the reform of the review and approval system, purify the ecological environment of clinical trials, strengthen the protection of innovative drugs, and promote the development of innovative drugs in China as a whole.