摘要
欧盟是我国原料药出口主要地区,我国在出口原料药的注册、监管要求等方面与欧盟存在一定差异。本文分析了我国出口欧盟原料药的现状,概述了我国和欧盟对出口原料药的监管政策,探讨了我国出口欧盟原料药监管中存在的不足,并提出对策建议:相关企业积极对标新规范要求,履行好药品上市许可持有人质量主体责任,持续做好出口药品质量管理;监管部门依据风险评估和分级,创新监管模式,持续做好出口欧盟原料药的监管。
The European Union(EU)is the main region for Chinese export of active pharmaceutical ingredients and there are many differences between China and the EU in terms of registration and regulatory requirements for exporting active pharmaceutical ingredients.This paper analyzes the current situation of Chinese export of active pharmaceutical ingredients,outlines the regulatory policies of China and the EU on exporting active pharmaceutical ingredients,explores the shortcomings in Chinese export of active pharmaceutical ingredients,and proposes countermeasures and suggestions:Enterprises should actively meet the requirements of new standards and regulations,fulfill their main responsibilities,and increase the quality of exported drugs.Regulatory authorities should innovate the supervision mode and strengthen supervision according to the scientifically risk-based supervision mechanism.
作者
张杰
肖杰
柏建学
曹鸿雁
李强
周勇
ZHANG Jie;XIAO Jie;BAI Jian-xue;CAO Hong-yan;LI Qiang;ZHOU Yong(Shandong Center for Food and Drug Evaluation and Inspection)
出处
《中国食品药品监管》
2023年第7期86-91,共6页
China Food & Drug Administration Magazine
关键词
出口欧盟
原料药
现状
政策分析
存在不足
对策建议
export to the European Union
active pharmaceutical ingredients
current situation
policy analysis
shortcomings
countermeasure and suggestions
