中成药在马来西亚上市监管法规分析  

Regulatory Rules for Market Launching of Chinese Patent Medicines in Malaysia

作　　者：杨志城 孙彩虹 叶冠 YANG Zhi-cheng;SUN Cai-hong;YE Guan(Institute of Traditional Chinese Medicine,Shanghai Pharmaceutical Group Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]上海医药集团股份有限公司中药研究所,上海201203

出　　处：《中国现代中药》2024年第12期2158-2166,共9页Modern Chinese Medicine

基　　金：上海医药中药传承和创新平台能力建设项目(2020006)。

摘　　要：马来西亚邻近我国,长期受中医药文化及产品影响,已将传统及辅助医学纳入医疗监管系统范畴使其合法化。中国-东南亚国家联盟(以下简称东盟)自由贸易区建立以来,我国越来越多的中药出口至东盟地区,其中马来西亚为主要国家之一,中药出口均以药材为主,中成药较少,难以发挥中医药特色及优势、惠及马来西亚人民。2018年3月,马来西亚卫生部推出《马来西亚传统与辅助医药发展蓝图2018—2027(医疗篇)》,为我国中药企业进入马来西亚市场及药品上市销售奠定基础。结合2024年1月马来西亚发布的《药物注册指导原则3.0》及相关法规梳理马来西亚传统植物药注册管理机构、申报资料、注意事项等信息,为意欲开拓马来西亚市场的中药企业资料撰写提供参考,从而更好地推动中医药在马来西亚的上市与发展。Malaysia adjacent to China has long been influenced by the culture and products of traditional Chinese medicine(TCM),and it has legalised traditional and complementary medicine into the medical regulatory system.Since the establishment of the China-ASEAN Free Trade Area,more and more Chinese medicines are exported to the ASEAN region,where Malaysia is one of the major countries.Chinese medicinal materials account for a large proportion in exports,while Chinese patent medicines account for a small proportion,which makes it difficult to show the characteristics and advantages of TCM and to benefit the Malaysian people.In March 2018,the Ministry of Health of Malaysia issued the Traditional and Complementary Medicine Blueprint 2018-2027(Healthcare),which set the tone for China's TCM enterprises to enter the Malaysian market for marketing and sales.This paper reviews the Drug Registration Guidance Document(DRGD)3.0 issued in January 2024 and related regulations to sort out the information of Malaysian traditional botanical medicine registration institutions,declaration materials,and precautions,aiming to provide reference for TCM enterprises preparing to develop the Malaysian market in terms of data writing,so as to promote the development of TCM in Malaysia.

关 键 词：中成药 马来西亚 上市申请 药物注册指导原则3.0 

分 类 号：R282[医药卫生—中药学]