Synopsis
This
is the first guidebook of the China Pharmaceutical Guidebook Series. It will
provide a detailed introduction of the latest Chinese regulations for imported
drug registration, and guide overseas pharmaceutical manufacturers and
producers to file the application for their imported drugs with the Chinese
pharmaceutical authorities.
Summary
China
possesses a fourth population in the world and has one of the largest drug
markets round the world. By 2012, sales on the Chinese drug market have reached
RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market»
published by Chinese Academy of Social Sciences. It is estimated that it will
exceed RMB 1,000 billion by 2013. A series of factors, such as an increasingly
ageing population, accelerating growth of urban population as well as expansion
of healthcare covering urban and rural, will grow the Chinese drug market with
a growth rate over 20 percent per annum in next three years. China is expected
to become the second largest drug market in the world by 2015.
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Since
the reform and open door policy implemented by Chinese authorities in the late
1970s, the door of the Chinese drug market began opening up to the world step
by step, which gave a fillip to the imported drugs from overseas pharmaceutical
manufacturers and producers. By 2012, sales of imported drugs have shared one
fourth on the Chinese drug market. As China joins the World Trade Organization
(WTO) and integrates more completely into the global economy, it will further
open the door of a lucrative drug market for overseas pharmaceutical companies.
More and more overseas pharmaceutical manufacturers and producers expect to
enter such drug market and seize a larger part of such drug market. To enter
such a lucrative drug market, the first obstacle faced by overseas
pharmaceutical manufacturers and producers is how to file the application for
their imported drug registration with Chinese pharmaceutical authorities. 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 of
transparency.
Related reports by Radiant Insights: http://www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare
Therefore,
a comprehensive and thorough knowledge of the latest Chinese regulations for
imported drug registration has been become an essential prerequisite for
overseas pharmaceutical manufacturers and producers to achieve a successful
application for their products entry into the Chinese drug market. In despite
of since the drug registration implemented by the Chinese pharmaceutical
authorities on December 1, 2002, its regulatory regime has experienced
countless changes, and become increasingly compatible with international
standards, in turn, its ongoing consolidation will eventually contribute to a
healthier market environment. The Chinese Pharmaceutical authority promulgated
the last “Measures for the Administration of Drug Registration” on July 10
2007, and the last “Measures” entered into force since October 1, 2007.
However, the practical operations for application and approval of imported drug
registration have been constantly changed, because the amendment of “Measures”
is delayed. Under such circumstance, Access China Management Consulting Ltd
published the China Pharmaceutical Guidebook Series: 2013 Edition. The aim of
this guidebook series is to guide overseas pharmaceutical manufacturers and
producers to achieve a successful application and approval for their imported
drug registration. This guidebook series are composed of four guidebooks as the
following.
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Latest
Chinese Regulations for Imported Drug Registration: 2013 Edition
A
Comprehensive Guidebook for Foreign Pharmaceutical Companies
Material
and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration: 2013 Edition
A
Guidebook for Application of Imported Chemical Drugs Registration
Material
and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration: 2013 Edition
A
Guidebook for Application of Imported Biological Product Registration
Material
and Clinical Trial Requirements of Application and Approval for Imported Drug
Registration: 2013 Edition
A
Guidebook for Application of Imported Traditional Chinese Medicine and Natural
Medicine Registration
This
is the first guidebook of the China Pharmaceutical Guidebook Series. It will
provide a detailed introduction of the latest Chinese regulations for imported
drug registration, and guide overseas pharmaceutical manufacturers and
producers to file the application for their imported drugs with the Chinese
pharmaceutical authorities. Chapter 2 provides an overview of the main
responsibilities and organizational structure of the State Food and Drug
Administration (hereinafter called as SFDA) that is current Chinese
pharmaceutical authority at the central level, and takes responsible for
application and approval for imported drug registration. The aim of this
chapter is to give direction of gateway for application of imported drug
registration. Chapter 3 addresses the comprehensive regulations for imported
drug registration in China, from the classification of drugs, definitions
relating to application for imported drug registration, the application and
approval for imported drugs and repackaging of imported drugs, the
supplementary application and re-registration for imported drugs, the clinical
investigation for application of imported drug registration to the time limits
in drug registration. Chapter 4 introduces the procedures of application and
approval for imported drug registration, including the procedures of the
initial application and approval for imported drugs, the supplementary
application and approval for imported drugs, and the application and approval
for clinical trials relating to imported drugs. Chapter 5 provides an English
version of Application Form for Imported Drug Registration in order to facilitate
overseas audience to easily file the application of imported drug registration
with the SFDA. The guidebook concludes in chapter 6 by highlighting the
significant suggestions for overseas pharmaceutical manufacturers and producers
looking to achieve a successful application of their drug registration in
China. The appendices in chapter 7 include the Drug Administration Law of the
People’s Republic of China, the Regulations for Implementation of Drug
Administration Law of the People’s Republic of China, and the Chinese Good
Clinical Practice of Pharmaceutical Products. After have skimmed through this
guidebook, audience can be clearly aware of the latest Chinese regulations for
application and approval of imported drug registration. For the detailed requirements
of material items and clinical trial for application and approval of imported
drug registration of various categories, such as chemical drugs, biological
products, traditional Chinese medicines and natural medicines, audience can
learn from various fascicles of the China Pharmaceutical Guidebook Series.
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Here i got about traditional Chinese medicine and natural medicine. this is very beneficial China Pharmaceutical Guidebook Series. We are also high-tech pharmaceutical manufacturing company in China.
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