China Pharmaceutical Guidebook Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration A Guidebook of Registration Application for Imported Biological Products

In China, the development of biopharmaceutical industry is later andbehind the developed countries. Just for this reason, the requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and uniform. The SFDA (State Food and Drug Administration, China) divided the biopharmaceuticals for registration application into two classifications, that is 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. These guidelines provide only a common principle for themrespectively because of their diversity and complexity.

This is the fourth guidebook of the China Pharmaceutical Guidebook Series. It will provide a detailed introduction of SFDA’s requirements for materials and clinical trials of registration application and approval for imported biological products.

Publication Date: February 2007

Page Count: 65

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