The State Council: to support the international registration of patent drugs to relax the access to traditional Chinese medicine services
After the first working day of the new year, the State Council will focus on the field of medicine.
February 14th executive meeting of the State Council to promote innovation and upgrading of the pharmaceutical industry, to better serve the people's livelihood steady growth; to further promote the development of traditional Chinese medicine measures, to play the advantages of traditional medicine for the benefit of the people.
It is worth noting is that meeting the requirements, accelerate the tumor, diabetes, cardiovascular disease and other diseases and rare diseases of major pharmaceutical industry. Support has been patented domestic original research drug and branded generics to carry out the registration certification.
Chinese traditional Chinese Medicine Association Director Chen Yunhua told "Daily Economic News > reporter, the current domestic original research drug and branded generics in the process of going out is not smooth, special for traditional Chinese medicine, as a result of the assessment system in foreign countries can not meet, the internationalization of traditional Chinese medicine foot step slow. The executive meeting of the State Council from the point of view of government support to carry out the registration certification, will promote Chinese medicine market to overseas, pharmaceutical industry to promote innovation and upgrading, promote the development of pharmaceutical economy.
Rare disease major drug industry
Meeting identified, aimed at the masses in urgent need of strengthening the original research medicine, the first generic drugs, traditional Chinese medicine, new formulations, high-end medical equipment and other research and development innovation, accelerate tumor, diabetes, cardiovascular and cerebrovascular disease and other diseases and rare diseases of major drug industry.
In Chen Yunhua opinion, multiple disease and rare disease of major drug industry development, to solve the multiple disease, drug use in patients with rare diseases can be of great significance to promote the construction of China's health.
But there is a rare disease, many life-saving drugs is still in a state of shortage. The related with drug market demand for small, high cost of research and development, pharmaceutical companies with few profit to speak, lack of power production.
It is understood that the world is now known to be 7000 kinds of rare diseases, China has found that there are 5781, but in the world can be used in 378 kinds of effective rare disease drugs, China has less than 100.
Released in 2015 China rare diseases prevention and treatment research Academic Forum on rare diseases of the data display, in found 952 Chinese hospitalized patients with visible rare disease. The 152 species of rare diseases have listed the corresponding orphan drug, 16% of the disease belongs to "cure". In China only 50 kinds of rare disease has listed the corresponding orphan drug and received clinical approval or ongoing clinical trials, only 5% of the disease belongs to "cure".
Secretary of Party committee of Shandong Province Academy of Medical Sciences, Shandong rare rare diseases laboratory director Han, analysts say, due to less rare disease patients, drug development is difficult to obtain commercial return. Therefore, it is necessary to national policy incentives for pharmaceutical enterprises. But at present our country health care payment problems and drug development relative lack of motivation, resulting in a lack of domestic pharmaceutical companies on orphan drug research and development driving force.
To this end, the industry also frequently called for rare disease drug needs national policy support, directional production, tax relief, while the establishment of a national reserve system and alarm mechanism, timely adjustment of supply and demand.
But from the international point of view. The importance of rare diseases is increasing gradually.2015 years the U. S. Food and Drug Administration (FDA) of orphan drug approval, in 2015, the FDA approved a total of 45 new drug, which has 21 drugs for rare diseases, accounting for nearly half of the annual drug is approved (47%).2015 years is also FDA ever approved orphan drug for up to one year.
According to data from the health sector industry and market research firm EvluatePharma show that in 2018 the market for rare disease drugs will reach $127 billion.
Support the internationalization of traditional Chinese Medicine
In addition, it is worth noting that the meeting clearly supported the patent has been obtained in the domestic original research and brand imitation pharmaceutical to carry out international registration certification.
"This for the promotion of Chinese pharmaceutical companies to go out is of great significance." Chen Yunhua said enterprises in the past for international registration of certification to meet a lot of difficulties, a certification for last several years still no results, the internationalization of Chinese medicine to the road of Chinese enterprises go quite hard.
It is reported that, at present, Chinese enterprises to send to the FDA approval of a number of traditional Chinese medicine, only Tasly Compound Danshen Dripping Pills went to phase III clinical trials, but it also lasted for for a long time.
In early 1997, Tasly officially to the United States FDA proposed application of Compound Danshen dripping pills of clinical research on new drugs; in August 1998, the U. S. Food and Drug Administration (FDA) through the application for clinical study of the compound Danshen dripping pills; at the beginning of 2010, the compound Danshen Dripping Pills become the world's first through the United States FDA phase II clinical trial of compound traditional Chinese medicine.
Since then, in 2013, the compound Danshen dripping pill FDA three international clinical research was announced to start.
In this regard, Chen Yunhua explain said, FDA registered certification harsh, to go through pre clinical studies, a period, phase II, phase III clinical, to get recognition. Among them, especially for Chinese patent medicine, FDA review system is not applicable. For example, FDA reviewers for chemicals into clear, and clear the relationship between ingredient dosage effect, but a traditional Chinese medicine composition of more complex, it is difficult to identify.
Chen Yunhua said that the promotion of national level will promote China's good drug faster go out of the country and boost economic medicine. But at the same time, he said. It also needs to international to better understanding of traditional Chinese medicine, in accord with the development of traditional Chinese medicine review system to review.
In this regard, the meeting also proposed that the increased Chinese medicine investment and policy support. In the national essential drugs list to increase the number of varieties of traditional Chinese medicines, better play the "basic" role. To strengthen the research and extension of the Chinese philosophy, expand Chinese Medicine International Trade and dissemination.
It is worth noting, for the development of Chinese medicine, meeting also clear, relax the access of Chinese medicine services, improve the coverage of urban and rural areas of Chinese medicine service network to ensure social office and government run medical institutions of traditional Chinese medicine in practice, enjoy equal rights.
Chen Yunhua said broaden access to the development of the growth of the pharmaceutical market and related industries, but also need to strengthen supervision, to prevent the "near the medicine" phenomenon occurred, such as preventing does not conform to the provisions of acupuncture, massage and other institutions of breeding.
The source of this article: the daily economic news Author: Zhou Chengcheng