Discussion on Common Problems in Inspecting New Drug Qualification / 中国药房

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.