Guide to Prepare Application Dossiers for Oversea Medical Device Registration and Recordation in China

Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medicines:China Pharmaceutical Guidebook Series (4)

This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the Chinese pharmaceutical authorities requirements for materials and clinical trials of application and approval for imported traditional Chinese medicine.

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Summary

The traditional medicines in Orient, especially, the traditional Chinese medicines are always regarded by occidental as mysterious medicines. Until today not only the chemical composition of traditional Chinese medicines almost can not been expressed by a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly described by the modern medical terminologies. How the Chinese drug authorities to administer the registration application for such mysterious traditional Chinese medicines? This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of the Chinese pharmaceutical authorities requirements for materials and clinical trials of application and approval for imported traditional Chinese medicine. The Chinese pharmaceutical authorities collect the traditional Chinese medicines and the natural medicines into a category for registration application. Therefore, this guidebook will provide not only the introduction for registration application of imported traditional Chinese medicines but for the natural medicines.

Table Of Content

Chapter 1. Introduction.5

Chapter 2. Classification of Medicine Registration.8

2.1....