随着中国经济发展水平的不断提高,人们对创新医药产品的需求也越来越高。医药企业注重自身产品创新研发的同时,也日渐频繁地开展创新药品的授权引进交易。为促进创新药品的快速上市,中国推出了药品绿色通道注册制度。2019年修订后的《药品管理法》明确了药品上市许可持有人制度,结合《专利法》中药品专利衔接制度,为授权引进药品的后续顺利上市提供了制度和法律上的保障。
<<With the continuous improvement of China’s economic development level,people’s demand for innovative pharmaceutical products is also higher. While pharmaceutical enterprises pay attention to their own product innovation and R&D,they also carry out licensing and introduction transactions of innovative drugs more and more frequently. In order to promote the rapid listing of innovative drugs,China has launched a green channel registration system for drugs. The Drug Administration Law revised in 2019 defines the drug listing license holder system. Combined with the patent connection system of traditional Chinese medicine in the Patent Law of 2020,it provides an institutional and legal guarantee for the subsequent smooth listing of authorized imported drugs.
<<Keywords: | Authorized Introduction of DrugsGreen Channel for Drug RegistrationDrug Marketing License HolderDrug Patent Connection System |