Understanding China Food for Special Medical Purposes Clinical Trial Requirements

1. Clinical trial requirements for FSMPs are similar to pharmaceutical requirements.
2. ŸThe government provides 13 broad categories of disorders as examples in which FSMPs may be of therapeutic benefit however products are not limited to these categories.
3. ŸDifficulties in substantiating scientifically significant therapeutic/clinical benefit, trail size requirements and cost are major difficulties for successfully meeting China’s FSMP registration requirements.  

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  Summer Jiang
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