January 11th 2018, China Food and Drug Administration (CFDA) issued announcement about Accepting the Medical Device Oversea Clinical Trial Data Technical Guideline.
This guideline is used for directing the acceptance of the oversea clinical trial data as clinical trial evaluation documents during the CFDA registration application. This guideline came up with the ethical principles, legal principles and scientific principles for accepting oversea clinical trial data. Also it specified the document requirements and technical requirements for the oversea clinical trial data.
The guideline clarify the considerations and technical requirements through the technical review requirements, subjects, clinical trial condition differences and etc. And it will give specific clinical significance examples for the influence of different factors on the clinical trial data.
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