Synopsis
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. 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.
This guidebook provides a comprehensive and thorough knowledge of the latest
Chinese regulations for imported drug registration to guide overseas
pharmaceutical manufacturers and producers step by step to achieve a successful
application and approval for their imported drug registration to enter a
lucrative drug market in China.
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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.
Since
the reform and open door policy implemented by the 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.
Read Sample report of this Category: www.radiantinsights.com/catalog/pharmaceuticals-and-healthcare
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. 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.
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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 sluggish. Under such
circumstance, Access China Management Consulting Ltd published the China
Pharmaceutical Guidebook (2013 Edition): Latest Chinese Regulations for
Imported Drug Registration. The aim of this guidebook is to guide overseas
pharmaceutical manufacturers and producers to achieve a successful application
and approval for their imported drug registration. This guidebook is composed
of main four parts as the following.
A
Comprehensive Guidance of Imported Drug Registration
A
Guidance of Registration Application for Imported Chemical Drugs
A
Guidance of Registration Application for Imported Biological Products
A
Guidance of Registration Application for Imported Natural Medicines and
Traditional Chinese Medicines
Part
I provides a comprehensive guidance of imported drug registration, which
introduces an overview of the main responsibilities and organization structure
of the Chinese pharmaceutical authority ---- China Food and Drug Administration
(CFDA), 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, as well
as 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. All
such knowledge in Part I is essential to achieve a successful application and
approval for imported drug registration in China.
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