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

Implementation of the Drug Administration Law of the People's Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.

Chapter 2 provides an overview of the classification of medicine registration that is formulated by the CFDA. To understand this classification of medicine registration only is the first step for an application of traditional Chinese medicine and natural medicine registration, because applicant must file the application in accordance with this classification of medicine registration.

Chapter 3 addresses the material items for application of traditional Chinese medicine and natural medicine registration. The CFDA collected all materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. the summary materials, the research materials of pharmaceutics, the research materials of pharmacology and toxicology, and the materials of clinical investigation. For administrative requirement of traditional Chinese medicine and natural medicine registration, the CFDA provides the detailed explanations for many material items and precedes the ordinal numeral for each material item. When an application is filed, the CFDA will request applicant to submit the materials for application of traditional Chinese medicine and natural medicine registration of various categories in accordance with the material item's ordinal numeral. Therefore, to understand the material items is the second step for application of traditional Chinese medicine and natural medicine registration.

Chapter 4 introduces the requirements of material items for application of traditional Chinese medicine and natural medicine registration in terms of the form of material items and their explanatory notes. The form of material items represents the current requirements of material items for applica
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SOURCE MarketReportsOnline.com
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