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综观目前美国对植物药的管理要求,尽管FDA对其审批条件有所放宽,但我国中药要药品进入美国,还是有相当大的难度。目前美国FDA没有批准的绝大多数植物药,在美国都是以饮食补充剂(Dietary supplement,简称DS)来销售。因此,我国中药要打入美国,以采用饮食补充剂的形式也是一个较为适宜的途径。 1994年DSHEA(饮食补充剂保健和教育法)的颁布实施,开创了美国饮食补充剂行业管理的新纪元。此后,饮食补充剂行业特别是植物制品行业得
Looking at the present US regulatory requirements for botanical drugs, although the FDA has relaxed its examination and approval conditions, it is quite difficult for Chinese traditional medicine to enter the United States. At present, the vast majority of botanicals that the U.S. FDA did not approve are marketed in the United States as dietary supplements (DSs). Therefore, the Chinese medicine to enter the United States to adopt the form of dietary supplements is also a more appropriate way. The promulgation and implementation of the DSHEA (Dietary Supplement Health and Education Act) in 1994 created a new era in the management of the US dietary supplement industry. Since then, the dietary supplement industry, especially the plant products industry