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China Pharmaceutical Guidebook Series (3) Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products
Synopsis
This is the third guidebook of the China Pharmaceutical Guidebook Series. It provides a detailed introduction of CFDA’s requirements for materials and clinical trials of registration application and approval for imported biological products.
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Summary
The biopharmaceutical industry is one of the burgeoning industries. In the field of biopharmaceuticals, vast knowledge awaits people to explore. The biopharmaceuticals are diversified and complex. In China, the development of biopharmaceutical industry is far behind the developed countries. The requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and harmonized.
In China, the pharmaceutical regulatory authority —– the SFDA (State Food and Drug Administration, China) divided the biopharmaceuticals for registration application into two classifications, i.e. the therapeutic biological products and the prophylactic biological products. However, in the classification of therapeutic biological products, the SFDA does not provide the uniform requirements of materials and clinical trials for application of biological products for the gene therapy, the somatic cell therapy and the allergic therapy, but stipulates the other guidelines for them respectively. These guidelines provide only a general principle for them because of their diversity and complexity. Just for this reason, a comprehensive and thorough knowledge of the latest Chinese regulations for imported biological product registration is particularly important for overseas pharmaceutical manufacturers and producers to achieve a successful application for their products entry into the Chinese drug market.
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Reasons To Buy
• 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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