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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.


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。





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