China's pharmaceutical research is changing from "China new" to "global new"

Since the implementation of the new registration and classification reform of chemicals, 539 applications for registration of chemicals have been filed according to the new registration and classification, of which innovative drugs account for half of the total and 291 applications for registration, accounting for 53.99% Industry experts said that this means that in recent years, under the guidance of the "global new" policy, the pattern of drug registration and declaration dominated by generic drug declaration in the past is gradually being replaced by innovative drugs The change comes from the work plan for the reform of chemical drug registration and classification, which was issued last March The plan changed the definition of new drugs from "drugs not marketed in China" to "drugs not marketed in China and abroad", although it was only a one word difference, it brought about qualitative change, according to the relevant person in charge of the pharmaceutical registration department of the State Food and drug administration "This shows that the new drugs needed by the public are not simple repeats of existing drugs, but new ones with" global new "significance." Experts in the industry said that this is to encourage the industry to take the road of innovation and enhance the international competitiveness of China's pharmaceutical industry; at the same time, it is also to encourage foreign pharmaceutical companies to come to China as soon as possible, so that Chinese patients can use better and newer drugs as soon as possible In 2016, the structure of drug registration and declaration was significantly optimized, and the pattern of generic drug declaration was reversed Zhang Qing, director of the drug registration office of Shanghai food and drug administration, said that six of the 15 applications for registration of drug listing license holders filed in Shanghai last year were "global new" innovative drugs Dai Weimin, director of the new drug application service center of Taizhou pharmaceutical City, said that after the reform, the number of generic drug applications decreased dramatically, and the number of innovative drug applications increased gradually Among the new clinical approval documents in 2016, there were 11 new class I chemical drugs and 2 biological products, and the number of application for innovative drugs increased by 6.5 times over the previous year The new policy of drug review and approval reform has changed the pharmaceutical R & D ecology The R & D pattern from "China new" to "global new" has gradually formed, and a large number of innovative products are emerging "After the concept of registration classification reform is in line with the international standards, the gold content of new drugs has increased significantly The review and approval focus on the clinical value and application advantages of innovative drugs and improved new drugs, which is undoubtedly good for enterprises that really focus on research and development and quality." Green leaf Pharmaceutical Group Co., Ltd regulations and registration department director by Chunna said Compared with foreign countries, there is a big gap in the level of drug research and development in China According to "building a sustainable Chinese pharmaceutical innovation ecosystem" recently released by McKinsey consulting company, in 2015, the world's innovative drug market was nearly US $600 billion, but the market occupied by China was less than US $10 billion, of which 19 innovative products approved for listing for the first time in China contributed less than US $500 million It is difficult to develop innovative drugs, with long research cycle, large investment and high risk But in the long run, the R & D ability of innovative drugs is still the core competitiveness of enterprises Ding Jian, academician of the Chinese Academy of engineering and director of the academic committee of Shanghai Pharmaceutical Research Institute of the Chinese Academy of Sciences, said in an interview with the Economic Daily that a good policy environment is crucial for the success of new drugs, not just for enterprises and scientists In recent years, with the support of a series of policies of drug trial reform, new drug R & D has entered a new era, and innovative drugs are rising I believe that in the next few years, the pattern of domestic innovative drugs will be greatly improved Some pharmaceutical enterprises have suggested that we should speed up the reform of drug review and approval system, further improve review standards and specifications and technical guidelines, study policies such as clinical trial management, data protection, patent links and other policies to further encourage innovation, create a good policy environment for drug research and development innovation, and make more innovation achievements benefit the people Source: Economic Daily