中药提取物及其制剂注册管理研究
[Study on registration administration of extracts of traditional Chinese medicine and its preparation].
作者信息
Zhang Jian-Wu
机构信息
Beijing Drug Administration, Beijing 100053, China.
出版信息
Zhongguo Zhong Yao Za Zhi. 2013 May;38(10):1627-30.
PMID:23947153
Abstract
This paper studied the status of registration administration of extracts of traditional Chinese medicine (TCM) and its preparation, discussed some factors which affect the quality of extracts of TCM and its preparation, and puted forward some suggestions to strengthen the registration administration of extracts of TCM and its preparation such as clear positioning and legal basis, improving and enhancing quality standards, implementing of record management and so on.
摘要
本文研究了中药提取物及其制剂的注册管理现状，探讨了影响中药提取物及其制剂质量的一些因素，并提出了加强中药提取物及其制剂注册管理的建议，如明确定位与法律依据、完善和提高质量标准、实行备案管理等。
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