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New version of Measures for the Administration of Imported Medicinal Materials Released

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  • Source: Dongyang Information Network

    Recently, the State Administration of Market Supervision issued a revised "Administrative Measures on Imported Medicinal Materials" to implement classified management of first-time and non-first-time imported medicinal materials. The Measures entrust the examination and approval of the first-time imported medicinal materials to the provincial drug regulatory department where the applicant is located. The sample inspection originally undertaken by the China Food and Drug Inspection and Research Institute will also be adjusted to the provincial drug inspection agency accordingly. The administration of imports is simplified, and applicants can go directly to the port or the place where the border port is located to be responsible for drug supervision and administration for the record and apply for a customs clearance form for imported drugs. The "Measures" will be implemented from January 1, 2020.

    It is reported that, in order to implement the “Belt and Road” initiative and encourage the import of medicinal materials, the “Measures” removed the restriction that “the border port that allows medicinal materials to be imported can only import medicinal materials produced in countries or regions around the port”. At the same time, it is stipulated that the medicinal materials applied for import should meet the national drug standards, but considering that traditional U.S. and Tibetan medicines rely on imported medicinal materials, and ethnic minority medicinal materials that are used locally in ethnic minority areas are imported. Province, autonomous region standards for medicinal materials.

    The "Measures" emphasize supervision after the event and strengthen traceability management. Imported medicinal materials must pass the port inspection before they can be sold on the market. When purchasing imported medicinal materials, they must obtain relevant certification materials from suppliers and strictly implement the relevant provisions of drug retroactive management. . (Chief reporter Liu Zhiyong)

    (Editors: Xu Xinyi, Cui Yuanyuan)