China Pharmaceutical Guidebook: (2013 Edition) Latest Chinese Regulations for Imported Drug Registration
MUMBAI, December 11, 2013 /PRNewswire/ –
Bharat book Bureau presents China Pharmaceutical Guidebook: Latest Chinese Regulations
for Imported Drug Registration.(
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 end of 2012. A series of factors, such
as an increasingly ageing population, accelerating growth of the 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. 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.
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 product entry
into the Chinese drug market.
The aim of this guidebook is to guide overseas pharmaceutical manufacturers and
producers to achieve a successful application and approval for their imported drug
– A Comprehensive Guidance of Imported Drug Registration
The first segment 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). CFDA
requests the applicant to submit complicate and reliable materials for application of
imported drug registration.
– A Guidance of Registration Application for Imported Chemical Drug
The second segment provides a guidance of registration application for imported
chemical drugs, which addresses CFDA’s requirements for materials and clinical trials of
application and approval for imported chemical drug registration, including radioactive
– A Guidance of Registration Application for Imported Biological Products
The third segment provides provides a guidance of registration application for
imported biological products. 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
– A Guidance of Registration Application for Imported Natural Medicines and
Traditional Chinese Medicines.
The fourth segment provides a guidance of registration application for imported
natural medicines and traditional Chinese medicines. The traditional medicines in Orient,
especially, the traditional Chinese medicines are always regarded by occidental as
mysterious medicines. Until today not only the chemical composition of traditional Chinese
medicines almost can not be expressed by a precise chemical structural formula, but also
the indications of the majority of traditional Chinese medicines still cannot be clearly
described by the modern medical terminologies.
Who should buy this report?
– 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.
Request for sample report (http://www.bharatbook.com/RequestSample.asp?pid=198479)
For more information on the report: (
Category – Pharmaceutical
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