The theory of Chinese medicine stagnation spread to the mass media

Source: pharmasia news 2014-06-26 Beijing - an article entitled "why Chinese people can't eat new drugs" in Sanlian Life Weekly brought this hot issue, which was originally the focus of the pharmaceutical industry and regulators, into the attention of the mass media The new drugs approved by western countries will take about 5-8 years to go on the market in China, which is a long-term problem for multinational pharmaceutical companies They have been trying to speed up the process of new drug approval Although they have achieved some success in speeding up the green channel of approval, there are still many varieties waiting in line for the approval of the State Food and Drug Administration (CFDA), and the team changes more and more Yuan Yue, the lead author of this article, paid close attention to this issue In an interview with Pharmaceutical News in Asia, he said that for many other industries, foreign new products can often be listed synchronously in China or easily imported into China He wanted to understand why the pharmaceutical industry, which is at the forefront of science and technology, would become an exception The article of Sanlian Life Weekly on the phenomenon of "drug stagnation" in China: "today's Chinese people can enjoy any new products synchronously with foreign countries (except for ideological goods) as long as they pay taxes according to law, only drugs can't." There was a similar phenomenon of "drug stagnation" in Japan, a neighboring country of China, because the new drugs that Japanese pharmaceutical companies have already listed abroad must be re tested in Japan But many of these studies show that ethnic differences are very small or not at all, so the Japanese deregulated Yuan Yue said that in China, most varieties still need to be retested in China Coupled with the lengthy regulatory approval process, China's "drug lag" time is almost the longest in the world He added that the report convinced him that the process must be accelerated so that patients have access to more new drugs and medical devices, which means the public needs to put pressure on it "We must respect science," Yuan said He added, "patients should set up their own advocacy groups to urge the resolution of this problem, which will help to shorten the drug lag time." Yuan Yue's report is based on interviews with several senior executives of the Regulatory Affairs Department of multinational pharmaceutical companies, including pan Lihua of Novartis, Li Weiping of Johnson & Johnson's Xi'an Janssen Pharmaceutical and Li Jie of Pfizer In addition, Yuan Yue interviewed some local enterprises, such as Shanghai Fosun Pharmaceutical Co., Ltd and Joseph CHO, executive president of rdpac (full name of "pharmaceutical research and development industry committee of China Association of foreign funded enterprises", a trade organization representing large pharmaceutical enterprises in China) Yuan Yue, the introduction expert, said he believed that an urgent reform was the need to introduce more experts into the regulatory system "The root of China's drug stagnation problem is that the relationship among the government, the people and the enterprises has not been straightened out The Chinese government is an all-round government, which is the result of history The common people are willing to let the government take all responsibilities As a result, government officials would rather not work than do the wrong job " Yuan Yue said after summarizing the communication with the industry, it is clear that what we need is scientific decision-making, and we should also listen to the voice of patients' advocacy organizations and industry organizations, which will help improve the new drug approval process On the surface of his article, CFDA has strengthened cooperation with other regulatory agencies, including the US FDA, in recent years, mainly because of the rapid development of commercial relations in the pharmaceutical and medical equipment industries, but more work still needs to be accelerated One of the suggestions is to purchase services from third parties to improve the efficiency of China's regulatory system Yin Li, deputy director of CFDA, recently proposed to speed up the drug approval process through market forces such as third-party services The international multi center road also faces many obstacles in the face of drug stagnation, and multinational pharmaceutical enterprises have adopted new strategies From the beginning of the new drug development stage, China has been involved in the international multi center clinical trials (MRCT), integrating the data obtained from foreign studies with the data from China or Taiwan and other countries with a large population of Chinese patients Yuan Yue said, but this road may not work Some officials have accused foreign drug companies of taking a shortcut to avoid clinical trials for new drug registration, so the practice faces adjustment Yuan Yue quoted an anonymous insider as saying: "from August 2013 to now, all new drug market applications (NDAs) supported by MRCT data have been suspended by CFDA." Joseph schereen, Bayer's head of global regulatory affairs, said in a previous interview with Asia Pharmaceutical News that the lengthy approval process has led to difficulties in implementing multi centers in China "In China, the approval process for clinical trial applications takes a long time," schereen said In contrast, the approval time of the United States, the European Union, Japan and other major countries is much shorter, so the inclusion of China as the experimental site will bring great challenges to MRCT, especially when the scale of the experiment is limited and the recruitment of subjects in other countries is progressing rapidly " Yuan Yue said that the challenge faced by MRCT will prevent new drugs for diseases with huge treatment demand from entering China, but the impact on the treatment of orphans and rare diseases is particularly significant He added that China urgently needs to speed up research and development in the field of children's medicine; there are a large number of children, but there are few reasonable doses to choose from At present, only adult drugs can be crushed or broken to meet the treatment needs of children However, this issue has attracted the attention of relevant departments CFDA and other departments jointly issued a document to encourage the research and development of children's drugs, promising to open up green channels for such products and accelerate the approval Yuan Yue said that local enterprises are no exception "The drug stagnation of domestic drugs is even more serious With the majority of generic drugs, only a few manufacturers are regarded as domestic leading enterprises Yuan Yue said that only about 5 indigenous innovative medicine varieties are currently being examined and approved, suggesting that new research and development models need to be adopted Of course, not everyone agrees Shao Ying, head of R & D of Shanghai Fosun Pharmaceutical industry, said: "if you are on the side of China, you will think that this is not so serious, and many diseases are treatable with drugs." According to Shao Ying, the strict approval of clinical trials can also be seen as a kind of protection for patients, and also to avoid the influx of high-priced imported drugs into China In fact, we have cheap substitutes for many indications However, an employee of a multinational pharmaceutical company told yuan Yue that only more than 20 million of the 100 million hypertensive patients in China have received drug treatment, which shows that China's drug supply is still insufficient and there is a lot of room for improvement, or at least doctors and patients should have more choices, if patients pay for their own drugs Yuan Yue quoted an industry insider who didn't want to be named: about half of the drugs in China are purchased by people at their own expense, and most of them are not on the national health insurance catalog Yuan Yue said that he didn't expect this article to attract so much attention He received a lot of replies and social media began to discuss it A post on Sina Weibo Weibo said that he stood up to speak fair for CFDA [see Sina Weibo post Chinese language] "To allow drugs to go on the market first and then to be clinical like FDA, it needs perfect laws, excellent technology, absolute prestige and leaders who dare to take responsibility Unfortunately, these things are not available in China at this stage." The author of this post is called "suspicious night", which means "solve the problem in the evening" in Chinese "It's not entirely CFDA's fault that China's new drug approval is slow Foreign companies have their own problems They want to enter the Chinese market, they don't want to bear the R & D risk, and they need to save the R & D cost How can there be such a good thing in the world?" Yuan Yue said he would not pay attention to these replies, but promised to make follow-up reports and discuss the issue in depth "We can't hope to change this situation by relying on one person and one article There is still a lot of work to be done to solve the problem of drug stagnation We need to do it step by step "