- 期刊
各國藥品賦形劑管理法規研析
Overview of Regulatory Framework for Pharmaceutical Excipients
並列摘要
Pharmaceutical excipients is one of the important factors which affect the quality of medicines. It is necessary to implement strict and efficient management system to ensure drug safety. In order to improve the management systems and the regulatory requirements, management standards implemented in Europe, the United States of America, Japan, Association of Southeast Asian Nations and China were investigated so as to draft the management standards suitable for our country. Harmonization with international standards shall be promoted to enhance the quality management system of our country and to make domestic drug products more internationally competitive.
延伸閱讀
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