《Table 2Selected herbal substances evaluated by the HMPC resulting in a monograph or a list entry[9]

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《欧盟监管环境视角下的传统医药全球化》

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The European regulatory framework does not only offer options for access to Chinese herbal medicines；it also sets limitations.The particular framework for traditional herbal medicinal products is not suitable for active substances of animal origin.The route of administration is restricted to oral administration，external use，and inhalation.Therefore，injections，which are quite common in TCM，cannot be granted a registration as traditional herbal medicinal products.Finally，registration is limited to minor diseases and is usually not designed for chronic application.Nevertheless，in some cases，registration as traditional herbal medicinal products has already been granted for products from TCM，such as capsules containing an aqueous dry extract of the dried rhizomes of Dioscorea nipponica，tablets containing an aqueous dry extract of dried aerial parts of Siegesbeckia orientalis，and capsules containing an ethanolic dry extract from the roots of Salvia miltiorrhiza.As the first three examples of successful registration of traditional herbal medicinal products in the Netherlands and in the United Kingdom，these registrations clearly demonstrate that it is possible to have access to the market in the EU on the platform provided by EU legislation.Furtherregistrationshavebeengranted，and applications are under assessment.