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China Pharmaceutical Guidebook Series (4) 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
Synopsis
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.
In China, like in other Western countries, the pharmaceutical authority —– China Food and Drug Administration (hereafter called CFDA) requests applicant to submit complicate and reliable materials for application of medicine registration. The CFDA 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 CFDA 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 CFDA 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.
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Reasons To Buy
• Companies wishing to enter a lucrative drug market in China.
• Companies interested in understanding the latest Chinese regulations on application and approval for imported drug registration.
• Senior executive officers engaging regulatory and registration affairs for drugs.
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