In the two years, the number of drugs awaiting review in China has decreased from 22,000 to 6,000, but the problem of low level of pharmaceutical industry duplication and serious shortage of drug development has not been effectively solved.
One of the reasons for this is that the system policy of encouraging drug innovation in China is not perfect. The excellent system design of some developed countries is only started in China.
The industrial structure of medicine industry is outstanding
On June 22, the state council's report on the work of drug administration was submitted to the twenty-second session of the standing committee of the 12th National People's Congress for deliberation.
Entrusted by the state council, the director of the state administration of food and medicine, bi jingquan, reported to the standing committee of the National People's Congress on drug administration.
For all the concerns about drug registration backlogs and the slow listing of new drugs, Mr. Bi said that the backlog of drug registrations has been largely eliminated. The application of chemical and vaccine clinical trial applications and various registration applications of Chinese medicine has been completed according to the time limit.
In fact, the drug review backlog has been linked to a large number of generic drug claims.
As early as in 2015, wu zhen, deputy chief of the state food administration of drug safety has publicly noted that drug approval a backlog of 21000 varieties, 90% is the medicine of generic drugs, and generic low threshold, big ShenBaoLiang, high repetition rate, caused serious backlog problem.
Mr. Bi said that in the era of the lack of medicine, the main task was to solve the shortage of medicines, and the drug listing standard was low. Twenty years ago, drugs were approved by the provinces (regions and municipalities), and the standards were not uniform. This is one of the causes of the serious homogenization of drugs in China.
Report shows that China's existing 15000 varieties corresponding to 168000 drug approval number, more than 100 of the varieties for 161, 50 ~ 100 varieties for the approval document of 100, most of the more than 800 varieties.
In addition, Mr. Bi said that China's drug research and development investment is seriously inadequate, and the r&d investment of China's pharmaceutical enterprises in 2016 was less than that of the largest pharmaceutical company in the world. There is a shortage of innovative drugs urgently needed, and structural problems are prominent.
On June 22, the standing committee of the National People's Congress vice chairman and secretary general wang Chen on behalf of the standing committee of the National People's Congress law enforcement inspection group to report to the standing committee of the National People's Congress on checking the implementation of the "drugadministration law of the People's Republic of China, points out that in a number of provinces and cities in the law enforcement inspection, our country medicine industry structural contradictions are still outstanding, some pharmaceutical enterprise research and development strength and inadequate investment, even some large enterprises, its r&d spending is less than 10% of revenue.
For the reasons for the lack of innovation of pharmaceutical enterprises in China, bi jingquan said that the institutional policies to encourage drug innovation are not perfect. Foreign innovative drug research, after completing phase I clinical trial, can we apply for phase I clinical trial in China. The clinical trial institutions have adopted the approval system to limit the effective utilization of clinical resources.
According to bi jingquan, a large hospital with the qualification of drug research and development, the contradiction between scientific research and medical treatment is prominent, and doctors' enthusiasm for participating in clinical trials of drugs is not high. Some developed countries, including drug test data protection, patent link, patent period compensation, etc., encourage innovative system design, which is still in the research stage.
Support for innovative drugs to be included in medicare
In this situation, it will further stimulate the innovation vitality of the pharmaceutical industry and improve the quality and efficiency of China's drug supply.
The reform of the review and approval system will be promoted in the future, Mr. Bi said. We will develop policies to encourage drug development and innovation, promote innovative drug research and development, promote industrial restructuring and upgrading, and reduce the low level of drug industry duplication.
Among them, include reforming clinical trial management. Simplify the qualification of clinical trial institutions and mobilize more resources to participate in clinical trials. Improve the mechanism of ethics committee and improve the efficiency of ethical review. Optimize clinical trial review procedures. Encourage medical professionals and medical experts to participate in clinical research and motivate researchers to develop new drugs. Moreover, we should improve the patent protection system for drugs, protect the rights and interests of innovators, protect the public access to drugs, and mobilize all parties to invest in the development of new drugs.
The Beijing minister, head of the medical management consulting center Shi Lichen "daily economic news" reporter interview, points out that to speed up the review of examination and approval, new drug post-marketing clinical to more quickly into the hospital, enterprises can quickly get profits, there will be a lot of money into research and development, it has inspired enthusiasm of enterprise development.
Still, Mr. Shi says, the new drug will not be able to pay for the new drug when it enters the hospital. China's health care directory has been set for four to five years, and it has set the bar for innovative medicines to enter hospitals.
Since the first edition of the health insurance directory in 2000, China has made two adjustments in 2004 and 2009 respectively. Eight years later, the latest edition of the health care directory was issued in February. Previously, due to the medical insurance directory is not adjusted for a long time, innovative drugs into medical insurance directory, in addition to clinical drug demand disconnect, ginseng protect personnel to purchase catalog burden, also damage the enthusiasm of the enterprise research and development of new drugs. Drug companies can't get access to the health care directory because of new drugs. Drug companies can't get stable hospital sales. R&d investment can't be compensated by the health insurance fund.
Bi jingquan, said perfect medical insurance drug catalogue dynamic adjustment mechanism, support innovation medicine in a timely manner in accordance with provisions in the basic medical insurance to pay limits, support first imitation innovation medicine and medicine public bidding.
In fact, innovative medicine has entered the health care directory, which has been reflected in the adjustment of the health care directory this year. Sealand securities (5.520, 0.01, 0.18%), according to a research report of 2009 listed in the directory adjustment get focus on new drugs, including approval from 2008 to 2008 in the first half of our country's innovation in medicine and biological products, the vast majority were included in the 2017 edition of pharmaceutical medicine catalogue or negotiations, only a few varieties because of does not belong to medical insurance to pay limits (vaccine) or clinical recognition not be incorporated into low reasons, the quick measures for new product innovation drug firms play a significant role.
In addition, he pointed out that enterprises will be responsible for the overall life cycle management. According to the principle of matching the rights and responsibilities, the listed licensee shall be responsible for the product design, clinical research, production sales and adverse event reports. Establish a monitoring system for production enterprises to report adverse reactions directly. The effectiveness and safety evaluation of the listed injection are advanced in installments. We will conclude the pilot experience of listing license holders and try to implement it nationwide. |
