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在回归自然的背景之下,植物药产品越来越受到关注。植物药产品可以作作为饮食补充剂和药物进入美国市场。作为饮食补充剂可以直接在美国申请上市;而作为药物,分为非处方药(OTC)和新药(NDA)两种不同的途径申请上市。通过对植物药产品以饮食补充剂、OTC和NDA申请上市美国市场的3种不同的途径、相关的管理机构和关联法规做简要解析和比较,从而明确植物药产品在美国上市的不同途径的优缺点,以期对国内植物药产品的生产企业提供借鉴。
In the context of returning to nature, plant medicine products are getting more and more attention. Botanical products can be marketed in the United States as dietary supplements and medications. As a dietary supplement can be applied directly to the United States market; and as a drug, divided into over-the-counter drugs (OTC) and new drugs (NDA) two different ways to apply for listing. Through a brief analysis and comparison of the three different approaches to applying phyto-drug products to dietary supplements, OTC and NDA for listing in the U.S. market, the relevant regulatory agencies and related regulations, the advantages and disadvantages of different approaches to the listing of botanical drug products in the United States Shortcomings, with a view to the domestic plant medicine products manufacturers to provide reference.