摘要
目的为加强原料药监管提出建议。方法分析原料药产业监管现状和存在的问题。结果与结论应结合中国的国情,完善监管法规与制度,建立以原料药目录为依据的管理模式,强化GMP对原料药的规范内容,加强流通与出口管理,积极参与国际联合监管。
Objective To provide suggestions on improving supervision of active pharmaceutical ingredients （API）. Methods The current situation and problems of API industry supervision were studied. Results and Conclusion It is suggested that we, should revise API related regulations and laws, establish API listing management mode, strengthen the regulation of API by GMP, improve API circulation and export management and actively participate in the international co-supervision.
出处
《中国药事》
CAS
2012年第6期542-544,549,共4页
Chinese Pharmaceutical Affairs
关键词
原料药
药品生产企业
药品监管
active pharmaceutical ingredients
pharmaceutical manufacturers
medicine supervision
