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CFDA No Longer Requires Overseas Drug Registration Certificates for Imported Drug Registration

 John Li  2017-11-14    2017-11-24

CFDA has recently issued decisions concerning the adjustment of imported drug registration management. One of the biggest changes is that overseas registration certificate is no longer a pre-requisite condition for the application of clinical trial approval (CTA) or import drug license (IDL) for imported new chemical drugs or therapeutic biological products. Also for international mult-center clinical trial,  China can start phase I clinical trial simultaneously (except for preventative biological products). The decision comes into effect immediately since 10 Oct 2017

According to current provisions on drug registration, companies can only apply for clinical trial approval or import drug license for imported new drugs only when the drugs have been approved in the country of production or sale. This requirement has now been cancelled. This is one of recently CFDA's reforms to expedite the innovation and registration of new pharmaceutical products in China.

总局发布《关于调整进口药品注册管理有关事项的决定》

2017年10月10日, 为鼓励新药上市,满足临床需求,总局近日发布《关于调整进口药品注册管理有关事项的决定》(以下简称《决定》),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,对进口药品注册管理部分事项进行调整。

《决定》规定,除预防用生物制品外,在中国进行国际多中心药物临床试验的,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;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。《决定》还取消了化学药品新药以及治疗用生物制品创新药在提出进口临床申请、进口上市申请时,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。

《决定》自发布之日起实施,对于发布前已受理、以国际多中心临床试验数据提出免做进口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。

References

http://www.sda.gov.cn/WS01/CL0050/178362.html

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