China plans to shorten the time to market of imported drugs
Last Update: 2017-03-20
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Source: on March 20, 2017, according to the requirements of the original measures for the administration of imported drugs, the imported drugs applying for registration must obtain the registration approval and listing license from the drug authorities of the producing country The imported chemicals (including Hong Kong, Macao and Taiwan) that have not been approved for marketing at home and abroad shall be at least those that have entered phase II clinical trials abroad According to the surging news on March 20, some people in the industry said that in the past, it took an average of 3-4 years for imported drugs to enter the Chinese market for review In contrast, the FDA's standard time for drug review is 10 months, while the time for new drugs to be listed through the priority review is only 6 months Wang Shuguang, business partner of gaotejia medical investment group, said that if the draft can be implemented, in the short term, it will effectively shorten the listing time of imported drugs and directly benefit Chinese patients; in the long term, it will promote the overall progress of China's clinical drugs, pharmaceutical industry and biological medicine science "Judging from the draft, the country has made great determination." Wang Shuguang believes that "after the implementation of the new policy, it can promote the rapid progress of China's new drug evaluation system and make China's pharmaceutical enterprises keep pace with the international level." Wang Shuguang further explained that due to various reasons, the State Drug Administration had been cautious about the registration and listing of imported drugs in the past For example, it is currently stipulated that the drugs for international multicenter drug clinical trials in China shall have been registered abroad or have entered phase II or phase III clinical trials According to the regulations of the draft, a large number of foreign innovative drugs can enter China for clinical trials, greatly reducing the waiting time; at the same time, the application for listing of imported new drugs does not need to wait for foreign approval before it can be submitted in China "On the whole, the draft is scientifically adjusted on the basis of seeking truth from facts Although it is within a reasonable range, the magnitude is still somewhat unexpected It also reflects the determination and technical confidence of the national drug regulatory department in supporting the development of new drugs In the past, we dare not comment or even not comment on many new drugs The implementation of the draft will put forward high requirements for the technical level of the national drug regulatory department, especially the new drug review department The specific implementation needs to be able to compare with the FDA of the United States " Wang Shuguang said The draft will be open to the public for comments until April 20, 2017 Bi Jingquan, director of the State Food and drug administration, once said frankly that the lack of domestic approval personnel has objectively restricted the speed of the listing of imported drugs, according to the voice of China, a report by cctv.com "We have a relatively long time in drug review and a relatively small force in drug review The number of drug review centers in the United States is 5000 Through our efforts last year, the number increased to 600 at the end of last year We should say that the efficiency is higher than before, but there is still a gap We are now gradually improving the efficiency of approval by optimizing the process and increasing the strength Therefore, the backlog of drug review has improved significantly The backlog of drug reviews peaked at 22000, but dropped to 8000 by the end of last year " In the past two years, the State Food and drug administration has made many institutional attempts to speed up the listing of drugs At present, the drug marketing license holder system has been piloted in 10 provinces and cities Under this mechanism, marketing license and production license are independent of each other This means that drug R & D institutions can independently apply for drug listing Before that, many overseas pharmaceutical companies accelerated the approval and listing of drugs by setting up R & D centers in China Wang Shuguang, who has many years of experience in drug research and development, has been paying close attention to the development of new drugs in China He noted that in the past five years, the national new drug evaluation level has made remarkable progress, from administrative procedure oriented to scientific demonstration oriented On the other hand, China, as a big country of generic drugs, will bring far-reaching influence to the domestic pharmaceutical enterprises Wang Shuguang said that this will be conducive to the optimization of the overall structure of domestic pharmaceutical enterprises, promote the integration and merger of pharmaceutical enterprises, reverse the current unhealthy trend of falsification of clinical data of drug research and development in China, and also change the abnormal development trend of the generic drug market that takes channels as the king and ignores the efficacy "Accelerating the listing of imported drugs in China is a very good elimination mechanism, which can be said in the future Many pharmaceutical enterprises will die, which is also the inevitable trend for the pharmaceutical powers to turn to the pharmaceutical powers Once the policy of accelerating the listing of imported drugs is implemented, what kind of imported drugs will be the first to catch the new deal express is also a problem of great concern Wang Shuguang said that there are two major categories of drugs to be introduced: one is the special drugs urgently needed in China, such as anti-tumor drugs, metabolic drugs, antibody drugs, etc.; the other is the drugs with a large gap between the domestic R & D level and the international level, including psychotropic drugs, high-end preparations, etc.
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