中国现代中药2024，Vol.26Issue(12)：2158-2166,中插1,10.DOI:10.13313/j.issn.1673-4890.20240407007
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
摘要
Abstract
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3.0Key words
Chinese patent medicine/Malaysia/application for marketing/Drug Registration Guidance Document 3.0分类
医药卫生引用本文复制引用
杨志城,孙彩虹,叶冠..中成药在马来西亚上市监管法规分析[J].中国现代中药,2024,26(12):2158-2166,中插1,10.基金项目
上海医药中药传承和创新平台能力建设项目(2020006) （2020006）
