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China Pharmaceutical Guidebook guides 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 is composed of four main parts as the following.
A Comprehensive Guidance of Imported Drug Registration
A Guidance of Registration Application for Imported Chemical Drugs
A Guidance of Registration Application for Imported Biological Products
A Guidance of Registration Application for Imported Natural Medicines and Traditional Chinese Medicines
More and more overseas pharmaceutical manufacturers and producers expect to acquire the latest detailed information about the Chinese regulations for imported drug registration. In this guidebook, 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 in China. After have skimmed through this guidebook, audience can clearly acquire a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration. Access China Management Consulting Ltd hopes this China Pharmaceutical Guidebook ---- Latest Chinese Regulations for Imported Drug Registration, based on full and accurate regulations and law, can help guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration in China.
Report Highlights
An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration) that is current Chinese pharmaceutical authority at the central level, and takes responsible for application and approval for imported drug registration.
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.
A guidance of registration application for imported chemical drugs.
A guidance of registration application for imported biological products.
A guidance of registration application for imported natural medicines and traditional Chinese medicines.
The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their drug registration in China.
Many useful resources of law and regulations, including the Drug Administration Law of the People’s Republic of China, the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, the Chinese Good Clinical Practice of Pharmaceutical Products, the Chinese Good Manufacturing Practice for Pharmaceutical Products, the Form of Registration Application for Imported Drug, and so on.
Who should buy this report?
• 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.