本文選題：生物材料 + 入境��； 參考：《南京醫(yī)科大學(xué)學(xué)報(bào)(社會(huì)科學(xué)版)》2015年06期

【摘要】：美國(guó)生物材料入境監(jiān)管架構(gòu)對(duì)我國(guó)生物材料入境監(jiān)管有重要借鑒意義。其借鑒的重點(diǎn)和難點(diǎn)可從四個(gè)方面進(jìn)行探討:進(jìn)出口生物醫(yī)藥企業(yè)必須承擔(dān)誠(chéng)信管理的義務(wù);進(jìn)出口生物醫(yī)藥企業(yè)必須是生物安全管理的第一責(zé)任人;必須重視國(guó)際上成熟法規(guī)和技術(shù)的學(xué)習(xí)和引入,提高國(guó)內(nèi)出入境特殊物品相關(guān)法規(guī)的權(quán)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(chǔ)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(yàn)檢疫局衛(wèi)生監(jiān)管處;江蘇出入境檢驗(yàn)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(yàn)檢疫局立項(xiàng)課題“出入境生物制品病毒安全性檢測(cè)平臺(tái)”(2015KJ37)
【分類號(hào)】：R318.08;F203

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