Where is the way of pharmaceutical innovation?

Source: Guangming Daily January 25, 2016 innovation and R & D is the eternal theme of the pharmaceutical industry Zhang Yongxiang, member of the CPPCC National Committee and researcher of the Institute of toxicants and drugs of the Academy of Military Medical Sciences, said that the most critical link of drug innovation is the stage of discovery and research A prominent problem facing China is the lack of innovation ability at the source For this reason, he suggested that the basic research work of scientific research institutes should be closely linked with the actual needs, and a professional team should be set up to tackle the difficulties "We hope that innovative good medicine can benefit more patients, bring benefits to enterprises, and realize multi win for society, enterprises and patients." Recently, at the Symposium on the theme of "innovation and development of pharmaceutical industry" sponsored by the Ministry of political participation of the CPC Central Committee and other units, experts at the meeting called for taking positive measures to promote the innovation and development of pharmaceutical industry Enterprises are the real subject of innovation In view of the innovation and development of China's pharmaceutical industry, at the symposium, members of the CPPCC National Committee and experts from both inside and outside the labor party put forward their unique views and practical suggestions from the aspects of R & D, production and supervision Innovative R & D is an eternal theme innovative R & D is an eternal theme of the pharmaceutical industry Zhang Yongxiang, member of the CPPCC National Committee and researcher of the Institute of toxicants and drugs of the Academy of Military Medical Sciences, said that the most critical link of drug innovation is the stage of discovery and research A prominent problem facing China is the lack of innovation ability at the source For this reason, he suggested that the basic research work of scientific research institutes should be closely linked with the actual needs, and a professional team should be set up to tackle the difficulties For the pharmaceutical industry, whether it is to develop original new drugs or to copy other drugs with expired patents, innovation is needed From the current situation, most of the new drug R & D institutions in our country focus on generic drugs Experts said that this is determined by China's national conditions, which is also conducive to reducing drug prices and bringing benefits to patients But many generic drugs are more simple imitation, lack of innovative factors, there are not thorough research and poor efficacy According to Yang Hanyu, vice president of the Central Institute of pharmaceutical research of Shiyao group, generics can do better than the original research drugs by standing on the shoulders of giants He suggested that in-depth research on the original research products should be carried out to find out the key factors and carry out improvement and innovation However, this requires early experience accumulation and a large number of research work, as well as more investment from pharmaceutical enterprises Dong Xiaoping, member of the CPPCC National Committee and deputy director of the Institute of virus prevention and control of the China Center for Disease Control and prevention, believes that there is a great demand for medicine among the masses It is very important for pharmaceutical innovation to do a good job in research and development of high-end drugs The state should give full play to the guiding role of policies, encourage pharmaceutical enterprises to carry out innovative research and development of drugs with significant public welfare role, and at the same time, improve the standard threshold of drug innovation to ensure that the drugs produced can occupy the market After the completion of the research and development of some drugs, the pilot drug "OEM" production still faces the problem of listing Chen Kaixian, member of the National Committee of the Chinese people's Political Consultative Conference and academician of the Chinese Academy of Sciences, for example, said that a research and development institution has successfully developed a new drug after 12 years, but according to the current drug administration laws and regulations in China, the unit applying for the drug approval number must be the drug manufacturer, which is unable to build its own production line, and the drug can not be put on the market Chen Kaixian said that the management system of drug marketing license and production license has played a positive role in a certain historical period, making our drug safety responsibilities traceable However, with the gradual establishment and improvement of China's market economy system and the continuous development of drug research and development, the current management system has increasingly highlighted its limitations, raised the threshold of R & D achievements transformation and industrialization, resulting in the lack of innovation vitality in drug research and development, and the phenomenon of repeated investment is serious To this end, Chen Kaixian suggested that we should accelerate the pilot of drug listing license holder system and promote the development and innovation of China's biomedical industry Under this system, drug marketing license and production license are separated, that is to say, the ownership and production right of listed drugs can be separated The applicant for the drug listing license may produce the drug on his own, or entrust the qualified production enterprise with "OEM" to obtain the drug listing license In this way, the main body of drug responsibility is more clear The enterprises holding the listing license are fully responsible for drug safety, and the production enterprises are only responsible for the production process In case of quality problems caused by production reasons, the holder of the listing license may, after assuming the liability for compensation to the user, recover the compensation from the production enterprise in accordance with the contract This is also the drug management system that is generally implemented by the international community In November 2015, the Standing Committee of the National People's Congress authorized the State Council to carry out pilot drug listing license holder system in 10 provinces and cities Not long ago, Beijing food and Drug Administration issued a document to support Zhongguancun's priority pilot drug listing permit holder system With the implementation of the pilot project, the risk points may be highlighted, and it is very important to establish an effective mechanism for risk control, Chen said He suggested that we should choose the key areas and key areas that have the necessary conditions first, strengthen the guidance on the basis of in-depth research, and promote radiation after gaining experience "Since the reform and opening up, we have solved the problem of lack of medicine, and now the prominent problem is overcapacity." Hou Yanning, member of the CPPCC National Committee and former vice president of Bethune International Peace Hospital, said that at present, there are 170000 drug approval numbers in China, two thirds of which are dormant, and more than 5000 drug factories Overcapacity leads to vicious competition in the market Some manufacturers are eager for quick success and instant profits, and they need to reduce costs by drilling holes More attention should be paid to the quality of drugs Hou Yanning believes that quality supervision is an important link to promote the upgrading of the pharmaceutical industry, and corresponding supporting measures must be taken She suggested improving the drug quality monitoring system to promote the survival of the fittest and industrial upgrading of pharmaceutical enterprises, establishing a professional team to strengthen drug quality supervision and give them the power of law enforcement She said that these measures will force manufacturers to improve drug quality, guide and regulate industry behavior, and promote healthy and sound development of the industry "It's not that there's no regulation, but there's regulation It's mainly about regulatory reform." Yue bingfei, member of the CPPCC National Committee and director of experimental animal research institute of CFDA, said that the evaluation mechanism of drug listing needs to be improved to solve the problem of "bad money expelling good money" Enterprises should also actively provide technical parameters and experimental data of drugs to promote the elimination of bad drugs According to the historical records of the chairman of the pharmaceutical policy research special committee of China pharmaceutical innovation promotion association, the innovation of regulatory model cannot be separated from the optimization of drug supply measures Centralized procurement needs to develop more to information services, regulatory services and rational drug use services He said that all provinces and cities should fully integrate their own conditions and establish and improve the drug supply and security system based on the basic drug system Shao Yiming, member of the National Committee of the Chinese people's Political Consultative Conference and chief AIDS expert of the China Center for Disease Control and prevention, suggested that we should improve the working mode of the national drug review regulatory agency, speed up the drug review, change the concept and concept of the past review from a scientific perspective, and simplify the unnecessary and safe procedures "We should promote the work of regional sub centers, establish drug variety evaluation centers, take the national drug testing as a chess game, explore a new work mode of vertical management and division of responsibilities, so that our national drug regulatory system can truly play a role at all levels and levels," he said