The management method of drug R&D and production binding needs to be reformed

China's pharmaceutical industry has experienced rapid development for more than 30 years, and has the ability to guarantee the basic drug use of residents However, the innovation ability of pharmaceutical industry is low, and the overall quality of products is not high There are only 5 kinds of innovative drugs with independent intellectual property rights in China, and only 20 kinds of national first-class new drugs There are some phenomena, such as "not new" innovative drugs, low level of generic drugs, imported patent drugs, and "made in China" no market abroad The homogeneity and low-level competition of the pharmaceutical industry are serious, and the profits of most enterprises are about 3% These problems reflect that the current regulatory system does not meet the needs of the development of modern pharmaceutical industry, especially the binding of drug R & D and production, which inhibits innovation and wastes resources According to the current laws and regulations, the unit applying for drug approval number must be the production unit A considerable number of enterprises in China have advanced production capacity and passed GMP certification, but they can only produce products with their own R & D and batch number However, a large amount of investment and a long period of time are needed for drugs from R & D to batch number acquisition, and many advanced production capacity can only be idle There are also some enterprises with strong R & D capability, but in order to obtain drug approval number, they must invest heavily in building new production lines that meet GMP standards, which affects the R & D investment and restricts the improvement of innovation capability In developed countries and regions such as the United States, Europe and Japan, MAH is widely used, that is, the separation of drug marketing license and production license The holder of the marketing license is mainly engaged in the research and development of drugs After obtaining the approval number of drugs, he can produce them by himself or entrust them to different manufacturers For example, Pfizer, Bayer, GlaxoSmithKline and other enterprises generally carry out drug research and development by themselves, and transfer or commission the production process This makes drug market licensors focus more on R & D, control the high-end industry chain, and better integrate R & D and production The entrusted production enterprises pay more attention to the production process and realize the specialized division of labor in the industrial chain The system of listing licensors is similar to OEM in electronic and garment industries In order to promote the healthy development of the pharmaceutical industry, China should implement the policy of encouraging professional division of labor, liberalize the binding of listing license and production license, and establish the listing license system One is to modify the provisions of the drug administration law and other relevant laws and regulations, and establish the "Qualification Access" drug listing license system The drug marketing license will be issued to those who have been qualified for marketing The listing licensors must meet the standards for research and development, and may entrust different manufacturers with the production of the products The responsibility for the quality, adverse reactions and recall of drugs shall be borne by the listing licensors, and the entrusted production enterprises shall only be responsible for the listing licensors Second, establish a drug adverse reaction relief system In order to protect the rights and interests of consumers after the separation of drug research and development from production, it is suggested that all the listed licensors should contribute to establish a drug injury relief fund for the relief and compensation of adverse drug reactions At the same time, we should further explore the commercial insurance mechanism of drug damage compensation, and guarantee the rights and interests of consumers through multiple levels and channels.