Research and Markets: Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration

DUBLIN--(Business Wire)--
Research and Markets
(http://www.researchandmarkets.com/research/af0b43/material_and_clini) has
announced the addition of the "Material and Clinical Trial Requirements of
Application and Approval for Imported Drug Registration: A Guidebook of
Registration Application for Imported Chemical Drugs China Pharmaceutical
Guidebook Series (2) (3rd edition)" report to their offering.

China possesses a fourth population in the world and has one of the largest drug
markets round the world. By 2006, sales on the Chinese drug market have reached
$12 billion dollars, an increase of 3.8 fold over 1998 level. 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 of 20-25 percent per annum in
next five years. China is expected to become the fifth largest drug market in
the world by 2010.

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 2006, sales of imported drugs
have shared one fifth 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 to 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.

Key Topics Covered:

* Preface
* Chapter 1. Introduction
* Chapter 2. Classification of Drug Registration
* Chapter 3. Material Items for Application of Drug Registration
* Chapter 4. Requirements of Material Items for Application of Drug Registration

* Chapter 5. Requirements of Clinical Trial for Application of Drug Registration

* Chapter 6. Material and Clinical Trial Requirements for Radioactive
Pharmaceuticals
* Chapter 7. Conclusion
* Chapter 8. Appendices

For more information visit
http://www.researchandmarkets.com/research/af0b43/material_and_clini

Laura Wood
Senior Manager
press@researchandmarkets.com
Fax from USA: 646-607-1907
Fax from rest of the world: +353-1-481-1716

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