摘要
目的提高我国药用辅料的监管水平。方法分析我国药用辅料现状,对中国、美国、欧洲药用辅料的监管模式进行对比。结果与结论应通过健全药用辅料监管法律法规和质量标准;对药用辅料重新包装和运输过程进行严格的质量控制;逐步实施GMP认证管理等措施,进一步加强药用辅料的监督管理。
Objective To improve the quality of supervision on pharmaceutical excipients in China. Method The current situation of Chinese pharmaceutical excipients was analyzed and the supervision pattern of pharmaceutical excipients in our country was compared with those in America and Europe. Results and Conclusion Through improving supervisory management laws and regulations, and quality standards of pharmaceutical excipients, the repackaging and transport of pharmaceutical excipients should be strictly controlled, and GMP authentication should be conducted gradually, thus strengthening the supervision and management of pharmaceutical excipients.
出处
《中国药事》
CAS
2014年第2期128-133,共6页
Chinese Pharmaceutical Affairs
关键词
药用辅料
质量标准
管理模式
比较
pharmaceutical excipients
quality standards
regulatory medel
comparison
