闡述了中藥復(fù)方和歐盟草藥復(fù)方質(zhì)量評估的法律基礎(chǔ)，著重分析了中藥復(fù)方和歐盟草藥復(fù)方質(zhì)量評估的一般要求以及復(fù)方中活性成分的識別和含量測定的要求，并從評估方法、分析檢測等方面比較了中歐雙方在質(zhì)量評估要求的差異，為中藥復(fù)方更好的適應(yīng)歐盟草藥復(fù)方質(zhì)量評估要求的法律性規(guī)范起到了指引的作用。

The paper elaborates the legal basis of Chinese herbal formula and European Union herbal combination, analyzes the general requirements of quality assessment, the identification, and assay of each active substance in Chinese herbal formula and European Union herbal combination. It also compares the difference on the requirements of quality assessment, such as the assessment methodologies, the analysis and detection, etc, between China and European Union to provide instructions for Chinese herbal formula to follow the legal practice on quality assessment of European Union.