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China Pharmaceutical Market Guidebook Series (4) 2013 Report
Date:5/22/2013

tion of traditional Chinese medicine and natural medicine registration stipulated by the CFDA. The explanatory notes further explain the requirements of material items for various categorical traditional Chinese medicines and natural medicines. To understand the contents of this section is a core for application of traditional Chinese medicine and natural medicine registration. The application of imported traditional Chinese medicine and natural medicine registration must accord with the material items prescribed by the form of material Items and the explanatory notes to submit materials.

Chapter 5 addresses the requirements of clinical trial for application of traditional Chinese medicine and natural medicine registration. There are two parts, i.e. the general requirements of clinical trial and the special requirements of clinical trial for imported traditional Chinese medicines and natural medicines.

The guidebook concludes in chapter 6 by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their traditional Chinese medicine and natural medicine registration in China. Lastly, there are appendices in chapter 7.

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