Transnational new drugs lag in "three reports and three batches" domestic innovative drugs still need to be accelerated

Recently, in the medical circle, the word "three newspapers and three batches" has been widely spread According to industry insiders, since June this year, pharmaceutical companies have found that the original enterprise has completed relevant clinical trials in accordance with the approved international multi center trials When the enterprise submits the Chinese patient data meeting the requirements of Chinese registration for the registration of new drugs, it is still required to go through the application process of clinical registration again After being approved, it can submit the registration again Due to the impact of this new process, the time to market of new drugs will be delayed for two to three years In this regard, experts in the industry believe that, on the premise of ensuring drug safety, it is advisable to simplify the process so that patients can use new drugs in line with international standards in time and enjoy the achievements of scientific and technological innovation The listing of new drugs is a win-win situation for pharmaceutical companies and patients Professor Gao runlin, an expert in cardiology, pointed out in an interview that the listing of new drugs is not only profitable for pharmaceutical companies, but also beneficial for patients "For example, the new antiplatelet drug tegrarol, compared with clopidogrel, reduces all-cause death and cardiovascular death, reduces stent thrombosis and myocardial infarction, and does not increase the risk of massive bleeding; now it is only a few dollars more expensive than clopidogrel, but with pharmacoeconomics calculation, tegrarol saves more medical expenses in general because it reduces death and cardiovascular events Tegrillo is listed in China almost at the same time with many countries New drugs and morning markets like this are good for the country and the patients " Gao runlin stressed that there is a very important basic principle to enjoy the benefits of new drugs on the market, that is, the safety of drugs is the first, and the effectiveness should be investigated on the basis of safety The real security data can only be obtained when it is applied on a large scale Gao runlin believes that in the stage of new drug development and clinical trials, if the international multi center already contains enough Chinese people, it can prove that the safety and efficacy of Chinese people are consistent with the total population In order to be listed in China, it will take another few years to do a new test, go through the approval process, and extend the time for three to five years to make it unnecessary for Chinese people to use drugs In response, Professor Pan Changyu, chief physician of Department of endocrinology of General Hospital of PLA, agreed She believes that it is better for China to actively participate in international multi center trials at the stage of new drug research and development, but the current bottleneck lies in the long time of domestic batch trials "People will soon be able to approve, but we will not, so that the probability of our participation in China and the number of projects will be reduced Moreover, Chinese doctors have been praised for their excellent performance in international trials over the years We hope that SFDA can understand and approve to participate in the international multicenter trial as soon as possible, so that we have enough time to select enough subjects to complete the trial and meet the sample size requirements of SFDA, then we can approve to go on the market, so as to omit the third stage clinical practice Meanwhile, the patients in China can enjoy the new drug treatment simultaneously with those in the world, and at the same time, the effectiveness and safety of the new drug treatment can be compared among patients of different races " It takes time and effort to encourage independent innovation and speed up the approval process to introduce new drugs to multinational pharmaceutical enterprises, and the capacity of independent innovation of domestic pharmaceutical enterprises is also limited In Pan Changyu's eyes, this kind of innovation feels "hard to define" "To make a new drug, we need to constantly look for thousands of chemicals, find effective RE modification, and then do many pre clinical toxicology, pharmacology and other tests, small animals, large animals, and then slowly do it with multiple people It's not easy If the drugs of domestic pharmaceutical companies are approved as innovative drugs in category 1.1, in fact, such innovation is not complete innovation Innovative drugs are called class 1 new drugs, which need our encouragement and support " According to Gao runlin, we can consider shortening the approval time to speed up the listing of new drugs "In general, clinical trials of new drugs should first be applied to the drug regulatory department by the pharmaceutical factory, which will take about a year In the face of endless new drug queuing and other approval phenomena, the drug regulatory department is really very short of manpower, and there are many contents to be reviewed, which is a difficulty to be overcome and solved However, for new drugs, can approval be faster than review? Because the review involves the listing of drugs, and the approval is only whether China will join the clinical trial If the review needs one year, the approval may not be one year, which can save some time " Gao said.