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    Home > Active Ingredient News > Drugs Articles > In 2019, the reform of drug review and approval continued to deepen. What are the achievements?

    In 2019, the reform of drug review and approval continued to deepen. What are the achievements?

    • Last Update: 2019-10-18
    • Source: Internet
    • Author: User
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    [industry trends of pharmaceutical network] since this year, the reform of drug review and approval system has been continuously deepened, promoting the transformation and upgrading of China's pharmaceutical industry, and promoting the steady improvement of drug quality Data shows that at present, 331 drug registration applications have been approved in China, including 11 overseas new drugs urgently needed in clinic In addition, 277 generic drugs of 110 varieties have completed the consistency evaluation of quality and efficacy of generic drugs In 2019, with the continuous improvement and implementation of the "life-saving drugs" priority review and approval policy, the drug regulatory process has been greatly accelerated, and the number of innovative drugs listed in China has continued to rise At the same time, it has also attracted global innovative drugs to accelerate their entry into the Chinese market, and many overseas pharmaceutical companies are interested in R & D and innovation in China For example, overseas media reported in August that Novartis plans to submit 50 new drug applications in China between 2019 and 2023 Novartis believes that China's accelerated approval of new drugs may make China the second largest market, surpassing Europe On May 30 this year, Pfizer announced that the global headquarters of its newly formed business unit, Pfizer up John, was located in Shanghai, which is also the place for foreign pharmaceutical companies to put their global headquarters in China The company said it can be seen that there is a great demand for reducing NCDs in low - and middle-income countries, and the global headquarters are put in China to get closer to the market The company seeks to build a database in China that tracks patient trends and side effects On May 28, the new drug development and supply building invested $53 million by AstraZeneca was launched in Wuxi It is understood that China has become AstraZeneca's second largest market in the world In addition, Roche pharmaceutical from Switzerland also places the position of innovation and R & D in China It is reported that Roche will invest 863 million yuan to build a new innovation center in Shanghai this year, focusing on research and early development of innovative drugs in the fields of immunity, inflammation and anti infectious diseases It can be seen that with the improvement of China's innovation and R & D environment, the acceleration of examination and approval, and the growing pharmaceutical market, foreign pharmaceutical enterprises are deeply attracted At the same time, China accelerated the examination and approval of imported innovative drugs, adding confidence to the market In the future, there will be more and better introduction of innovative drugs, which will benefit the majority of patients in China In recent years, good progress has been made in consistency evaluation In July this year, the 2018 annual drug review report issued by the drug review center of the State Drug Administration pointed out that the goal of solving the backlog of registration applications and achieving the review and approval of various registration applications within the prescribed time limit in 2018 has been basically completed successfully
    The specific performance is as follows: the acceptance capacity of drug registration applications has increased by 47%; the backlog of registration applications has been effectively solved, with the approval rate of more than 90% on time, and the waiting in line for review has been reduced to 3440; the R & D innovation has been encouraged, and the priority of review has been given to accelerate the further implementation of the systems such as the review of new drugs urgently needed in overseas clinical trials and the implied license system for clinical trials; the quality of drugs has been further improved, and it is consistent Sexual evaluation and further implementation of the catalogue of drugs on the market According to the industry, we are optimistic about the development of China's innovative drug industry driven by the review and approval reform We mainly recommend innovative drug enterprises such as Hengrui medicine, Fosun medicine, Junshi biology, Xinda biology, etc., as well as cro companies such as yaomingkant and tiger medicine In addition, with the progress of consistency evaluation and the implementation of policies such as purchasing with volume, high-quality generic drugs are expected to have structural opportunities East China pharmaceutical, Enhua pharmaceutical, Lepu medical, etc are mainly recommended.
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