Study on the Policy Trends of Encouraged Generic Drug Catalogue in China / 中国药房

ABSTRACT

OBJECTIVE：To know about the current situation and trend of encouraged generic drug catalogue policy in China ， and to put forward countermeasures and suggestions for the better implementation of the policy. METHODS ：The evolution of encouraged generic drug catalogue policy in China ，the characteristics of 2 batches of included types in encouraged generic drug catalogue，the implementation effect of the first batch of encouraged generic drug catalogue ，the development trend and existing problems of encouraged generic drug catalogue policy were analyzed to put forward corresponding suggestions. RESULTS & CONCLUSIONS：The evolution of encouraged generic drug catalogue policy in China can be roughly divided into embryonic stage，policy design stage and policy implementation and adjustment stage. The first batch of included types in encouraged generic drug catalogue are mainly drugs whose patents are about to expire and the competition is insufficient ，drugs with clinical necessity ， definite curative effect and short supply ，and varieties for special clinical purposes such as the prevention and treatment of major infectious diseases and rare diseases ，and children ’s use. The second batch of included types in encouraged generic drug catalogue are mainly those with expired patents （about to expired ）and insufficient competition ，and also those with special clinical uses. Among the types of the first batch of encouraged generic drug catalogue ，the number of abbreviated new drug application （ADNA） increased by 18，involving a total of 8 varieties；only 3 ADNA were included in the priority review ，accounting for 16.67％. In 2019 and 2020，218 and 119 varieties were newly included in the medical insurance catalogue ，and 3 varieties were newly included in the encouraged generic drugs catalogue （accounting for 1.4％ and 2.5％ respectively）. At present ，encouraged generic drug catalogue policy in China has the trend and characteristics of patent oriented regression ，lack of priority review and approval system，and enhanced linkage with the medical insurance catalogue. It is suggested to adhere to the original intention of the Opinions of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices in 2017，continue to adhere to the patent orientation of encouraged generic drug catalogue ，and improve the priority review system of generic drugs in the catalogue ，explore the “first imitation market monopoly period ”system in line with the characteristics of encouraged generic drug catalogue policy in China with reference to the U.S. FDA competitive imitation therapy guidelines ，and further strengthen the cooperation between government departments in the implementation of the encouraged generic drug catalogue policy.