Regulatory Rules for Market Launching of Chinese Patent Medicines in Malaysia
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.
Chinese patent medicineMalaysiaapplication for marketingDrug Registration Guidance Document 3.0
国家科技期刊平台
NSTL
万方数据
