Abstract
The regulatory framework for in vitro diagnostic reagents in China has been undergoing fast and fundamental changes. In addition to the knowledge of the in vitro diagnostic reagent market in China, it is also important for international companies to know the current regulations and the clinical requirements that, if met, will efficiently and successfully put their products in China market. In this chapter, we will provide a brief review of the key regulations and the corresponding clinical requirements related to in vitro diagnostic reagent development. The overview of the regulations and the requirements for clinical trials of in vitro diagnostic reagents will help international applicants decide their development strategies and conduct their clinical trials of in vitro diagnostic reagents in China.
The contents focused on in this chapter will include, (a) the detailed Chinese classification and naming principles for in vitro diagnostic reagents; (b) registration and development pathways as well as their requirements; (c) the unique requirements for clinical trials ofin vitro diagnostic reagents, including the basic principles of clinical trials and the clinical trial design; (d) the writing of clinical study reports; and (e) the writing of instructions. The above contents are based on the latest versions of corresponding regulations or reports by authoritative agents.
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Xu, C., Lu, E., Wang, J. (2015). In Vitro Diagnostic Product Development. In: Lu, M. (eds) Approaching China's Pharmaceutical Market. Springer, Cham. https://doi.org/10.1007/978-3-319-15576-0_10
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DOI: https://doi.org/10.1007/978-3-319-15576-0_10
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Publisher Name: Springer, Cham
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Online ISBN: 978-3-319-15576-0
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