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http://www.aarkstore.com/categories/index.asp Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration 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 third 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. In China, like in other Western countries, the pharmaceutical authority ----- China State Food and Drug Administration (hereafter called SFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The SFDA stipulated the classification of medicine registration in order to administer the application of traditional Chinese medicine and natural medicine registration. At the same time, the SFDA collected the materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items in accordance with various medicine categories. When an application of traditional Chinese medicine and natural medicine registration is filed, the SFDA will request applicant to not only submit designated material items in accordance with prescribed category of traditional Chinese medicines and natural medicines to apply for registration, but also conduct the clinical trials for certain categorical traditional Chinese medicines and natural medicines. Chapter 2 provides an overview of the classification of medicine registration that is formulated by the SFDA. 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 SFDA collected all materials for application of traditional Chinese medicine and natural medicine registration into four categories and 33 items, i.e. the comprehensive 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 SFDA provides the detailed explanations for many material items and precedes the ordinal numeral for each material item. When an application is filed, the SFDA 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. For more information, please visit :- Marketing Team Aarkstore Enterprise Phone:08149852585 Email:enquiry@aarkstore.com URL:www.aarkstore.com http://twitter.com/aarkstoredotcom http://in.linkedin.com/in/aarkstore http://www.facebook.com/aarkstoreenterprise http://www.aarkstore.com/reports/Material-and-Clinical-Trial-Requirements-of-Application-and-Approval-for-Imported-Drug-Registration-A-Guidebook-of-Registration-Application-China-Pharmaceutical-Guidebook-Series-3-4th-edition--139442.html More Related Reports :- China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration Chinas Guidebook for Pharmaceutical Patent Protection Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application.... 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