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China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration
Access China Management Consulting Ltd, May 2009, Pages: 286
In July 2007, the Chinese pharmaceutical authorities promulgated the latest “Measures for the Administration of Drug Registration”, and the latest “Measures” will enter into force since October 1, 2007. These “Measures” provide the latest detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance, Access China Management Consulting Ltd published this China Pharmaceutical Guidebook---- Latest Chinese Regulations for Imported Drug Registration. The aim of this guidebook is to guide overseas pharmaceutical manufacturers and producers to achieve a successful application and approval for their imported drug registration. 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
The guidebook concludes in Part V by highlighting the significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their drug registration in China. Last, the appendices in Part VI include the Drug Administration Law of the People’s Republic of China, the Regulations for 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, references, a useful resources of URL, author’s biography, and description of Access China Management Consulting Ltd.
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.
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