Liaoning Pharmaceutical reform forces pharmaceutical enterprises to innovate and survive

Source: Panoramic finance and economics 2016-7-5: there are dozens or even hundreds of enterprises producing the same drug, with different prices and different effects According to the deployment of the State Food and drug administration, from this year on, all generic drugs must reach the level of original research drugs within three years and complete the consistency evaluation, otherwise they will not be able to go on sale after 2018 This policy will undoubtedly bring huge impact to pharmaceutical enterprises and even the whole pharmaceutical industry Liaoning Province, as a large pharmaceutical production province, will complete the "big blood exchange, big shuffle" in this wave Under pressure, innovative enterprises will break through, and old enterprises will be eliminated by the market During a visit to the major pharmacies in Shenyang, a reporter from China economic times found that many drugs with the same name or ingredients are usually placed on the counter of the pharmacies Most of these drugs are imitated based on the patented original research drugs, which are often referred to as generic drugs Are these generic drugs consistent with the original drugs and efficacy? What are the differences between generic drugs and generic drugs? These are always the concerns of consumers Fang Liang, Dean of the school of pharmacy of Shenyang Pharmaceutical University, told our reporter that there are indeed many problems with generic drugs In order to further regulate the drug market, the State Food and Drug Administration issued a notice at the beginning of this year, designating 289 generic drugs, and emphasizing that about 1.8 of the drugs approved before 2007, which belong to the national basic drug catalog, should be Ten thousand approval number related products are selected for consistency The purpose is to eliminate those drugs with poor efficacy and safety, so that people can use truly effective, safe and cheap drugs Liaoning food and Drug Administration said that there are 206 pharmaceutical enterprises in Liaoning Province, including more than 150 generic pharmaceutical enterprises The effect of these generic drugs is uneven, and the low profit price war is a kind of harm to enterprises "We want to see that this generic consistency evaluation is an opportunity for the pharmaceutical industry to upgrade and transform, which forces our enterprises to take a path of independent innovation." Liaoning mindI Biopharmaceutical Technology Co., Ltd is an innovation driven enterprise growing up from the incubator of Benxi pharmaceutical capital Its annual scientific research investment accounts for more than 35% of the total sales Even in such a cruel competitive environment, the enterprise can still rely on innovative drugs to maintain its profit point Zhang Jianxia, general manager of the company, said frankly“ Under the impact of carrying out the policy of generic drug consistency evaluation, the generic drug industry is facing a new round of reshuffle, and those small and medium-sized pharmaceutical enterprises that are unable to follow up the technology upgrading are bound to fall into crisis Therefore, in our industry, no matter how the policy changes, innovation is the eternal theme, and only this way can we continuously improve the core market competitiveness " In Benxi pharmaceutical capital, Shanghai Green Valley Benxi Pharmaceutical Co., Ltd., there are also pressure of consistency evaluation on drugs However, the first mannan oligosaccharide diacid production line of the enterprise has started trial operation Once the latest national drugs developed in more than 20 years are put into production, the annual sales revenue can reach more than 10 billion yuan Zhao yilie, general manager of the company, told reporters that most of the drugs produced by the company will face the impact of consistency evaluation, not only through the official heavy identification, but also waiting for the final evaluation of the market These processes are very unfavorable to pharmaceutical enterprises, which have no choice and have been in a passive state The newly developed drug is a new class of anti dementia drugs in the country Although it has invested heavily in the early stage, it will become the most powerful barrier against competition once it is formed In order to speed up the development of drug R & D and pharmaceutical industry in Liaoning Province, the food and Drug Administration of Liaoning Province is also innovating its regulatory thinking and launching precise support actions for innovative drug R & D "We will focus on supporting innovative drug research and development projects of enterprises based on the principles of innovation orientation, collaborative promotion and support in place We plan to use 5 years to provide one-to-one precise assistance and support for 20 to 30 new drug R & D projects in the province, and promote the formation of a number of innovative backbone enterprises " Liaoning food and Drug Administration said Wang Guangji, deputy to the National People's Congress, academician of the Chinese Academy of engineering and chairman of the academic committee of the Chinese Pharmaceutical University, believes that China has a long way to go in terms of generic drug varieties and specifications, more complex situation and consistency evaluation In January 2012, the State Council launched the quality consistency evaluation of generic drugs, which has become the top priority of drug supervision in recent years Wang Guangji believes that, first of all, we should give full play to the role of government guidance and regulation, strengthen regulatory responsibility, and avoid pushing this work to enterprises and society At the same time, the number of certified drug clinical trial bases in China is insufficient, and only 82 institutions can undertake human bioequivalence test and phase I clinical test, which directly affects the smooth implementation of the evaluation work At present, there are more than 600 pharmaceutical universities and more than 2000 tertiary hospitals in China, which are good bases for increasing evaluation resources He suggested that on the premise of adhering to the standards, we should speed up the construction and identification of clinical bases and evaluation institutions.