The China Pharmaceutical Guidebook Series are the essential resources of the latest Chinese regulations for imported drug registration. This new guidebook series guide overseas pharmaceutical manufacturers and producers step by step to achieve a successful application and approval for their imported drug registration to enter a lucrative drug market in China. This guidebook series are composed of four guidebooks as the following.
Latest Chinese Regulations for Imported Drug Registration:
A Comprehensive Guidebook for Foreign Pharmaceutical Companies
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
A Guidebook of Registration Application for Imported Chemical Drugs
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
A Guidebook of Registration Application for Imported Biological Products
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
In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration.
This is the first guidebook of the China Pharmaceutical Guidebook Series. It provided a detailed introduction of the Chinese latest regulations for imported drug registration, and guide overseas pharmaceutical manufacturers and producers to file the application for their drugs with the Chinese pharmaceutical authorities.
Scope of the Report
An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration)
The comprehensive regulations for imported drug registration in China, from the classification of drugs, definitions relating to application for imported drug registration, the application and approval for imported drugs and repackaging of imported drugs, the supplementary application and re-registration for imported drugs, the clinical investigation for application of imported drug registration to the time limits in drug registration.
The procedures of application and approval for imported drug registration, including the procedures of the initial application and approval for imported drugs, the supplementary application and approval for imported drugs, and the application and approval for clinical trials relating to imported drugs.
The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their pharmaceuticals registration in China
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