為促進新型冠狀病毒肺炎（COVID-19）疫苗和治療藥物在歐盟的開發(fā)和應(yīng)用，歐洲藥品管理局（EMA）于2020年12月發(fā)布了“COVID-19疫苗說明書靈活性問答”，并于2021年3月又發(fā)布了“COVID-19治療藥說明書的靈活性”兩個文件，表明EMA對COVID-19疫苗和治療藥物的包裝說明書和標(biāo)簽的審批采取了不同于常規(guī)做法的靈活措施，以加速COVID-19疫苗說明書和標(biāo)簽的審批。其中主要說明具體的簡化要求，如可只用英文，而不要求用本國文字；在早期階段可以省略外包裝紙盒內(nèi)的包裝說明書；印刷包裝說明書的數(shù)量可少于注射次數(shù)；在早期階段標(biāo)簽可省略一些細節(jié)等等。中國雖然出臺了一系列有關(guān)COVID-19疫苗的指導(dǎo)原則，但還沒有涉及說明書和標(biāo)簽。介紹EMA的兩個文件，以期對我國該方面的工作有所啟示，尤其是對供歐盟成員國使用的國產(chǎn)疫苗有直接的參考價值。

EMA issued the Questions and answers on labelling flexibilities for COVID19 vaccines in December 2020 and the Labelling flexibilities for COVID-19 therapeutics in March 2021 to promote the development and application of COVID-19 vaccines and therapeutics in the EU. The two documents indicate that EMA has adopted flexible measures different from the conventional practice in the approval of the package leaflets and labels of the COVID-19 vaccines and therapeutics, so as to accelerate the approval of the package leaflets and labels of the COVID-19 vaccines and therapeutics. Among them, it mainly explains the specific simplified requirements, for example, it can only use English instead of national language; in the early stage, it can omit the packaging leaflet in the outer carton; the number of printed packaging leaflets can be less than the number of doses; in the early stage, some details can be omitted from the label, and so on. Although China has issued a series of guidelines on the COVID-19 vaccine, there are no packaging leaflets and labels involved. This paper introduces the two documents of EMA, which will have enlightenment for our work in this field. In particular, it has direct reference value for domestic vaccines used by EU Member States.

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