加拿大、韩国、新加坡和马来西亚新药注册申请监管程序对我国的启示

The inspiration to China from new drug applications in Canada,South Korea,Singapore and Malaysia

近年来,在国家政策的大力引导下,我国新药研发领域不断向前迈进,成果瞩目。在此基础上,中国新药产品进入国际市场已成为必然趋势。本文对比研究加拿大、韩国、新加坡和马来西亚4个国家新药注册申请监管程序,以期为我国药品监管程序提供切实可行的建议,促进监管体制的完善。

In recent years,under the vigorous guidance of national policies,new drug research and development has continued to move forward with remarkable achievement in China.Therefore,it is an inevitable trend for the new drug products that are domestically produced to enter the international market.This article compares the regulatory procedures for new drug applications in Canada,South Korea,Singapore and Malaysia,in order to provide practical suggestions on drug regulatory procedures for China,and promote the improvement of its regulatory system.