《Table 3Herbal substances evaluated by the HMPC resulting in a Public Statement[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 key steps mentioned may be helpful for planning and consideration during the very early stages of product development.In order to achieve progress and proceed to the development of a dossier，the project should be supported by competent partners in Europe（e.g.，partners in industry or consultants）.The most valuable and essential recommendation is to consider scientific advice either by national authorities or at the level of the EMA（HMPC or CHMP）.Scientific advice is available at any step of product development，and earlier is better for the applicant.The fees are reasonable，questions can address particular procedural or scientific issues，and the results are documented through a confidential protocol.Scientific advice may also be useful to elaborate major challenges in an early stage in order to allow wise decisions to be made about investments related to a project.In appropriate settings，scientific advice will substantially increase the chance of being successful.