原研地产化产品参比制剂自证申请情况及其几点考虑

Analysis and consideration on the applications of localized original drug on reference preparation for the chemical generic drugs

通过近两年来化学仿制药参比制剂自证申请平台数据,从具体品种、剂型、申请机构等多个维度,分析自证申请平台信息情况及其主要特征,并基于自证申请及其审评情况提出几点考虑。参比制剂为化学仿制药研发过程中关键因素之一,建议申请人在充分调研与对比研究的基础上提出自证申请,以期为原研地产化参比制剂申请及仿制药一致性评价的推进提供科学依据与参考。

According to the localized original drug records on the reference preparation filing platform for the consistency evaluation of generic drugs in recent 2 years,from multiple dimensions such as variety,dosage form,applicant agency,we analyzed the characteristics of the reference preparation application of localized original drug in China.The choice of reference preparation was a key point in the generic drugs research process,and it is suggested that institutes should timely submit the applications for filing on the basis of full investigation and comparison with original drug,in order to provide scientific evidence and reference for the applications of localized original drug and generic drug consistency evaluation.