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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China Pharmaceutical Guidebook Series (2) Material and Clinical Trial
Requirements of Application and Approval for Imported Drug Registration:
A Guidebook of Registration Application for Imported Chemical Drugs

2. China Pharmaceutical Guidebook Series (2) Material
and Clinical Trial Requirements of Application and
Approval for Imported Drug Registration: A Guidebook
of Registration Application for Imported Chemical
Drugs
Synopsis
 This is the second guidebook of the China Pharmaceutical
Guidebook Series. It will provide a detailed introduction of CFDA’s
requirements for materials and clinical trials of application and
approval for imported chemical drug registration, including
radioactive pharmaceuticals.
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More information available at https://www.themarketreports.com/report/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

3. Summary
 In China, like in other Western countries, the pharmaceutical authority -----
the State Food and Drug Administration (hereinafter called as SFDA)
requests applicant to submit complicate and reliable materials for application
of drug registration. The SFDA stipulated the classification of drug registration
in order to administer the application of chemical drug registration. At the
same time, the SFDA collected the materials for application of chemical drug
registration into four categories and 32 items in accordance with various
chemical drug categories.
 When an application of chemical drug registration is filed, the SFDA will
request applicant to not only submit designated material items in accordance
with prescribed category of chemical drug to apply for registration, but also
conduct the clinical trials for certain categorical chemical drugs.
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China Pharmaceutical Guidebook Series (2) Material
and Clinical Trial Requirements of Application and
Approval for Imported Drug Registration: A Guidebook
of Registration Application for Imported Chemical
Drugs

4. 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.
www.themarketreports.com
China Pharmaceutical Guidebook Series (2) Material
and Clinical Trial Requirements of Application and
Approval for Imported Drug Registration: A
Guidebook of Registration Application for Imported
Chemical Drugs

5. Scope
 This is the second guidebook of the China Pharmaceutical Guidebook Series.
It will provide a detailed introduction of CFDA’s requirements for materials
and clinical trials of application and approval for imported chemical drug
registration, including radioactive pharmaceuticals, from the classification of
drug registration, the material items for application of chemical drug
registration, the requirements of clinical trial for application of chemical drug
registration to the material and clinical trial requirements for application of
radioactive pharmaceuticals.
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China Pharmaceutical Guidebook Series (2) Material and
Clinical Trial Requirements of Application and Approval
for Imported Drug Registration: A Guidebook of
Registration Application for Imported Chemical Drugs

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