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.
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.
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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.
This
is the third guidebook of the China Pharmaceutical Guidebook Series. It
provides a detailed introduction of SFDA’s requirements for materials and
clinical trials of registration application and approval for imported
biological products. This guidebook will introduce SFDA’s requirements for
materials and clinical trials of registration application for imported
biological products in four parts and twelve chapters according to the existing
a serial of regulations and guidelines.
Read Sample report of this Category: http://www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare
The
Part I provides an introduction of the requirements for materials and clinical
trials of registration application for imported therapeutic biological
products. The Part II introduces the requirements for materials and clinical
trials of registration application for imported prophylactic biological
products. The Part III addresses the
requirements for materials and clinical trials of registration application for
imported gene therapeutic biological products and somatic cell therapeutic
biological products. The Part IV addresses the requirements for materials and clinical
trials of registration application for imported allergic therapeutic biological
products.
The
guidebook concludes in chapter 13 by highlighting the significant suggestions
for overseas pharmaceutical manufacturers and producers looking to achieve a successful
application for their biopharmaceuticals registration in China. Last, the
appendices in chapter 14 include the Drug Administration Law of the People’s
Republic of China, the Regulations for the Implementation of the Drug
Administration Law of the People’s Republic of China, the Chinese Good Clinical
Practice of Pharmaceutical Products, the Form of Registration Application for
Imported Drug, references, and description of Access China Management
Consulting Ltd.
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After
have skimmed through this guidebook, audience can be clearly aware of the
latest Chinese regulations on requirements of the materials and the clinical
trials for registration application of imported biological products. For the
detailed pathway and procedure for application and approval of imported
biological products, audience can learn from the first guidebook of the China
Pharmaceutical Guidebook Series (2013 Edition) ---- Latest Chinese Regulations
for Imported Drug Registration: A Comprehensive Guidebook for Foreign
Pharmaceutical Companies.
Scope
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, from the requirements for materials and clinical trials of
registration application for imported therapeutic biological products, the
requirements for materials and clinical trials of registration application for
imported prophylactic biological products, the requirements for materials and
clinical trials of registration application for imported gene therapeutic
biological products and somatic cell therapeutic biological products to the
requirements for materials and clinical trials of registration application for
imported allergic therapeutic biological products.
Reason 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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