State Food and Drug Administration: the revision of drug administration law has entered a critical stage

Source: 21st century drugstore 2016-11-25 "the drug administration law has gone through more than 30 years since it was promulgated and implemented in 1984, and has been revised for more than 10 years since 2001 With the continuous development of social economy, the law can not fully meet the regulatory needs under the new situation." Xu Jinghe, director of the legal department of the State Food and Drug Administration (hereinafter referred to as CFDA), said at the 28th national pharmaceutical economic information conference: "at present, China is in a critical period of drug regulatory reform and medical and health system reform, and the revision of the drug administration law has entered a critical stage We hope to seek opinions from the society as soon as possible." "The industry is very concerned about the issue of encouraging innovation At the beginning of the formulation of China's drug administration law, there was" emphasis on production rather than research and development " Because of the influence of the development stage and the restriction of the concept of planned economy, the incentive for R & D innovation is not enough Therefore, in the revision process of the drug administration law, we will take more measures to encourage innovation " According to the reporter, pharmaceutical enterprises are very concerned about the priority review system, data protection system, patent link system, patent extension system, new drug monitoring system, market monopoly system, etc For the drug market licensing system (hereinafter referred to as MAH), the prospect of pilot is also the focus of many pharmaceutical enterprises and research and development institutions Xu Jinghe said frankly: "we have analyzed and compared some measures at home and abroad, hoping to fully draw lessons from the MAH system that the international community encourages drug innovation, and hope to make the society have more understanding of the function of the system through the implementation of the MAH pilot Mah system can not only encourage drug innovation, but also optimize resource allocation, implement corporate responsibility and promote regulatory innovation " As for the transfer of drug approval documents that pharmaceutical enterprises are eager to look forward to, Xu Jinghe said frankly: "this issue is very concerned by the industry, and also paid attention to in the process of revision Drug approval documents have property attributes and administrative attributes The new law needs to give a clear positioning As a property attribute, it should be transferable; with administrative attribute, transfer license needs to perform administrative procedures, whether to adopt filing system or examination and approval system, need to be further explored To be sure, the change of holders can further stimulate the vitality of China's pharmaceutical market " Xu Jinghe did not disclose how the final draft of the drug administration law would be expressed He encouraged the representatives present at the meeting: "to encourage innovation, the new drug administration law will guide the transformation of China's pharmaceutical industry from imitation to innovation By further improving the market mechanism, we will realize the transfer liberalization, transfer liberalization and delegation liberalization, and fully release the reform dividend." In the aspect of enterprise supervision, pharmaceutical enterprises also have expectations: the new law can reform the way of supervision, reduce the burden of enterprises, and achieve efficient supervision under the policy of simplifying administration and delegating power Xu Jinghe said frankly: "the current drug administration law has a comparative principle for the main responsibility of enterprises In the revision, we will further strengthen the main responsibility of the enterprise as the first responsible person, and further refine the main responsibility of the enterprise around risk management and quality control " Under the policy of simplifying administration and delegating power, the new law will cancel the certification of GLP, GSP, GMP and GCP "From the perspective of the international community, drug regulation has generally gone through three stages of development," Xu stressed The first stage is mainly qualification management, which focuses on administrative licensing; the second stage is mainly system management, which focuses on process control; the third stage is mainly capability management, which focuses on the management capability of enterprises The revision of the drug administration law should be conducive to the overall prevention and control of risks, the overall implementation of responsibilities, the overall promotion of the system and the overall improvement of capabilities " Pay close attention to medical e-commerce since last year, medical e-commerce has attracted much attention, especially the lifting of the ban on online sales of prescription drugs, which has been expected by the industry The off shelf OTC of tmall medical center also worries the industry about the prospect of medical e-commerce For pharmaceutical e-commerce, Xu Jinghe revealed: "in the process of revising the drug administration law, I also pay close attention to the rapid development of pharmaceutical e-commerce In recent years, the rapid development of the Internet economy, especially the drug trade, has made me have some new thinking, and the industry has also fed back many opinions In the new law, we are willing to listen to different opinions." "Two vote system" is also the focus of the conference delegates "I also have a new understanding of drug circulation In the process of drug circulation, what kind of legal relationship should be between distribution and distribution has aroused my thinking," Xu said Distribution and distribution are totally different formats Distribution only provides transportation services and earns labor fees, while distribution directly distributes drugs With the implementation of the "two vote system", some changes will take place in the way of drug circulation, and the amendment will also pay attention to it "