Discussion on Common Problems in Inspecting New Drug Qualification
- VernacularTitle:医院新药引进资质审核中常见问题及讨论
- Author:
Hai YAO
;
Zhigang SONG
;
Ling GAO
- Publication Type:Journal Article
- Keywords:
Hospital;
New drugs;
Introduction;
Qualification inspecting
- From:
China Pharmacy
2001;0(10):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To strengthen the inspection for qualification of new drugs when introduced in order to guarantee the quality of new drugs and the safety of drug use.METHODS:The problems existing in the inspection for qualification of new drugs were exemplified and classified.RESULTS&CONCLUSION:There existed the problems in the respect of validity,authenticity,effectiveness,and integrality.The good maintainance of the database of SFDA plays a important role in in-specting the new drugs when introduced,while on the other hand such issues as establishment and use of credibility file in medical agencies are worth discussing.
