Analysis and Suggestion on Common Problems of Post-marketing Chinese Medicine Preparation for Record Changes in Guangdong Province
Objective:To provide guidance and suggestions for the record changes of post-marketing Chinese medicine preparation in China.Methods:By sorting out the acceptance and review of the record changes of post-marketing Chinese medicine preparation in Guangdong province in 2023,the problems and main reasons of the holder's declaration of the changes were analyzed,and feasible suggestions were put forward from the events before,during and after the change.Results and Conclusion:After sorting out the 213 varieties of post-marketing Chinese medicine preparation for record changes,it was found that the holders mainly had problems in record changes such as non-compliance of the declaration procedure,the non-standard filing content,and the non-sufficient of research verification.It is suggested that the hold er should reasonably establish the changes before the change,conduct scientifically research verification during the change,continue to pay attention to risk management after the change,and improve the ability of Chinese medicine preparation record changes.
post-marketingrecord changesChinese medicine preparationcommon problemsanalytical suggestions
NETL
NSTL
万方数据
