关键词:  , 生物制品；上市后变更；典型问题；风险分析

Abstract:

The post-approval change of biological products is an indispensable part of the whole life cycle of biological products， which may bring risks to the safety， effectiveness and quality of biological products. In order to help and guide drug marketing authorization holders （MAH） to carry out research validation and submit declaration materials efficiently and normatively， this study summarized the filing application situation of markted biological products in Shandong province， summed up the typical problems existing in the filing materials， including non-standard content of record， incomplete data of record and declaration， unreasonable determination of change grade， apply for extension of validity period but not complete the study required in product registration and approval， incomplete study on comparability of changes， etc. In view of the risks of the related problems， it is suggested that MAH should strengthen the management of post-approval produts according to relevant laws and regulations， determine the types of changes scientifically and rationally， and strengthen the communication mechanism with drug regulatory agencies， to effectively identify， assess and control the risks that may result from the changes， not arbitrarily reduce the types of changes， and further strengthen and implement MAH responsibilities as the main body of drug life-cycle quality assurance and ongoing research.The drug regulatory authorities should strengthen the supervision of post-approval changes， strictly check the record keeping of post-approval changes in the course of review， and resolutely refuse to record those that do not meet the requirements， ensure that the effectiveness， safety and quality controllability of the biological product after filing is not adversely affected by the change.

Key words:  , Biological products； , Post-approval changes； , Typical problems； , Risk analysis