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China Pharmaceutical Guidebook Series (2) Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs

Sunday, November 29, 2015 21:58

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Synopsis

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of CFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

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https://www.themarketreports.com/report/china-pharmaceutical-guidebook-series-2-material-and-clinical-trial-requirements-of-application-and-approval-for-imported-drug-registration-a-guidebook-of-registration-application-for-imported-chemical-drugs

Summary

In China, like in other Western countries, the pharmaceutical authority —– the State Food and Drug Administration (hereinafter called as SFDA) requests applicant to submit complicate and reliable materials for application of drug registration. The SFDA stipulated the classification of drug registration in order to administer the application of chemical drug registration. At the same time, the SFDA collected the materials for application of chemical drug registration into four categories and 32 items in accordance with various chemical drug categories. When an application of chemical drug registration is filed, the SFDA will request applicant to not only submit designated material items in accordance with prescribed category of chemical drug to apply for registration, but also conduct the clinical trials for certain categorical chemical drugs.

This is the second guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA’s requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

Chapter 2 provides an overview of the classification of drug registration that is formulated by the SFDA. To understand this classification of drug registration only is the first step for an application of chemical drug registration, because applicant must file the application in accordance with this classification of drug registration.