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China Pharmaceutical Guidebook: Latest Chinese Regulations for Imported Drug Registration
Date:6/17/2013

and seize a larger part of it.

In China, the process of application and approval for imported drug registration is very complex, because the Chinese pharmaceutical authorities administer and control this process by exorbitant administrative measures and regulations. Moreover, these exorbitant administrative regulations are variable and lack transparency. Therefore, a comprehensive and thorough knowledge of the latest Chinese regulations for imported drug registration has become an essential prerequisite for overseas pharmaceutical manufacturers and producers to achieve a successful application for their product entry into the Chinese drug market.

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.

Report Highlights

- A Comprehensive Guidance of Imported Drug Registration

The first segment provides a comprehensive guidance of imported drug registration, which introduces an overview of the main responsibilities and organization structure of the Chinese pharmaceutical authority. China Food and Drug Administration (CFDA). CFDA requests the applicant to submit complicate and reliable materials for application of imported drug registration.

- A Guidance of Registration Application for Imported Chemical Drug

The second segment provides a guidance of registration application for imported chemical drugs, which addresses CFDA's requirements for materials and clinical trials of application and approval for imported chemical drug registration, including radioactive pharmaceuticals.

- A Guidance of Registration Application for Imported Biological Products

The third segment provides provides a guidance of registration application for imported biological products. The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceutical
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SOURCE Bharat Book Bureau
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