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:
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration:
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 fourth guidebook of the China Pharmaceutical Guidebook Series. It provided a detailed introduction of the Chinese pharmaceutical authority’s requirements for materials and clinical trials of registration application for imported biological products.
Scope of the Report
The classification of biological product registration
The material items for application of biological product registration
The requirements of material items for application of biological product registration
The requirements of clinical trial for application of biological product registration
The guideline for application of biological products for human gene therapy
The guideline for application of biological products for somatic cell therapy
The guideline for application of biological products for allergic therapy
The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their biopharmaceuticals registration in China
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