Abstract:
OBJECTIVE To analyze the management system of Japanese cold medicine Kampo preparations, to analyze the approval and reimbursement management of typical preparations of Gegen decoction Kampo preparations, and to put forward relevant suggestions to promote the development of Chinese patent medicines in China.
METHODS The literature analysis method was used to check the literature, official policies and standards of Kampo preparations in Japan, sort out the classification management system of Kampo preparations in Japan, and analyze the situation of medicines.
RESULTS The classification and management system of Kampo preparations in Japan was relatively mature, and there was a special simplified approval process for non-prescription Kampo preparations.
CONCLUSION It is recommended that China may clarify the scientific classification management system of proprietary Chinese patent medicines, improve the contents of the instructions of proprietary Chinese patent medicines, and simplify the review and approval of proprietary Chinese patent medicines with rich clinical experience and low risk.