国家食品药品监督管理总局
关于调整进口药品注册管理有关事项的决定
The CFDA decision to adjust relevant matters of imported drug registration
(2017年10月10日)
根据《全国人民代表大会常务委员会关于授权国务院在部分地方开展药品上市许可持有人制度试点和有关问题的决定》《国务院关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号）要求，为鼓励新药上市，满足临床需求，经国家食品药品监督管理总局局务会议研究决定，对进口药品注册管理有关事项作如下调整：
一、在中国进行国际多中心药物临床试验，允许同步开展I期临床试验，取消临床试验用药物应当已在境外注册，或者已进入Ⅱ期或Ⅲ期临床试验的要求，预防用生物制品除外。
Regarding the international multi-center pharmaceutical clinical trial in China, it is allowed to perform the Phase I clinical trial in parallel in China. The requirement that the drugs to perform their clinical trials in China should be marketed or enter their Phase II or III clinical trials abroad is canceled, however, the preventive biologicals are excluded.
二、在中国进行的国际多中心药物临床试验完成后，申请人可以直接提出药品上市注册申请。提出上市注册申请时，应当执行《药品注册管理办法》及相关文件的要求。
After the international multi-center clinical trials are completed, the applicant for drug application can directly apply market authorization of their drug. During the drug registration, the Drug Registration Administration Methods and its Annexes shall apply.
三、对于提出进口药品临床试验申请、进口药品上市申请的化学药品新药以及治疗用生物制品创新药，取消应当获得境外制药厂商所在生产国家或者地区的上市许可的要求。
For the application of imported new chemical drug clinical trials and imported drug market authorization in China, if the drug is a new chemical drug or a new therapeutic biological, the precondition for registration that the drug muse be marketed in the country of origin is cancelled.
四、对于本决定发布前已受理、以国际多中心临床试验数据提出免做进口药品临床试验的注册申请，符合《药品注册管理办法》及相关文件要求的，可以直接批准进口。
For the applications before this decision, if applying waiver of clinical trial by submitting international multi-center clinical trial data and the dossier can meet the requirements of the Drug Registration Administration Methods and its Annexes, the drugs being registered can be approved directly for importation.
本决定自发布之日起实施。药品监管相关规章中有关规定与本决定不一致的，按照本决定执行。
This decision is implemented since its issuing date. If any discrepancies from other drug administrative regulations, this decision shall apply.