本文選題：生物材料 + 入境��； 參考：《南京醫(yī)科大學學報(社會科學版)》2015年06期

【摘要】：美國生物材料入境監(jiān)管架構對我國生物材料入境監(jiān)管有重要借鑒意義。其借鑒的重點和難點可從四個方面進行探討:進出口生物醫(yī)藥企業(yè)必須承擔誠信管理的義務;進出口生物醫(yī)藥企業(yè)必須是生物安全管理的第一責任人;必須重視國際上成熟法規(guī)和技術的學習和引入,提高國內出入境特殊物品相關法規(guī)的權威性和可操作性;生物材料入境監(jiān)管工作必須重視所需的基礎研究投入。
[Abstract]:American biomaterial entry regulatory framework is of great significance for China's biomaterial entry regulation. The key points and difficulties can be discussed from four aspects: import and export biopharmaceutical enterprises must bear the duty of good faith management, import and export biomedical enterprises must be the first responsible person in biosafety management; Attention must be paid to the study and introduction of mature laws and techniques in the world, to improve the authority and maneuverability of the relevant laws and regulations on entry and exit of special articles in China, and to attach importance to the basic research input required for the supervision of entry into the country of biological materials.
【作者單位】： 蘇州出入境檢驗檢疫局衛(wèi)生監(jiān)管處;江蘇出入境檢驗檢疫局衛(wèi)生監(jiān)管處;上海藥明康德新藥開發(fā)有限公司商業(yè)發(fā)展部;
【基金】：江蘇檢驗檢疫局立項課題“出入境生物制品病毒安全性檢測平臺”(2015KJ37)
【分類號】：R318.08;F203

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