An introduction to the determination path and management model of chemical initial products in Japan
LIU Yi-lin
NING Li-li
LI Fang
AN Na
HA Li-li
GUO Zhi-xin
Abstract：Based on the introduction to the determination path and management model of chemical initial products in the Ministry of Health,Labour and Welfare of Japan,this article provides reference for generic drug research and development enterprises in China that intend to select Japanese listed initial products as reference preparations and provides reference for regulatory agencies to determine the reference preparations of chemical generic drugs in China.
Keywords：Japaninitial productspath determinationmanagement model
Publication Date：2024-05-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 984-987 )