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BioPortfolio | Access China | China Pharmaceutical Guidebook Series (1)

China Pharmaceutical Guidebook Series

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. The latest "Measures for the Administration of Drug Registration" have entered into force since May 1, 2005. These "Measures" provide detailed requirements and procedures of application and approval for imported drug registration. Under such circumstance, Access China Management Consulting Ltd published the China Pharmaceutical Guidebook Series in the early 2006. 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.

Latest Chinese Regulations for Imported Drug Registration:

A Comprehensive Guidebook for Foreign Pharmaceutical Companies

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

A Guidebook of Registration Application for Imported Chemical Drugs

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

A Guidebook of Registration Application for Imported Biological Products

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

A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medicines

In this guidebook series, overseas pharmaceutical manufacturers and producers can easily find out every answer that they will meet question during process of application and approval for their imported drug registration. Since the publication of China Pharmaceutical Guidebook Series, many executives from overseas pharmaceutical companies have paid attention to this guidebook series, and expect to acquire further detailed information about Chinese regulations for imported drug registration, so that Access China Management Consulting Ltd completed the second edition in the early 2007 to contribute this second edition of China Pharmaceutical Guidebook Series to overseas pharmaceutical companies.

Report Highlights

An overview of the main responsibilities and organization structure of the SFDA (The State Food and Drug Administration) that is current Chinese pharmaceutical authority at the central level, and takes responsible for application and approval for imported drug registration.

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.

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.

The significant suggestions for overseas pharmaceutical manufacturers and producers looking to achieve a successful application for their pharmaceuticals registration in China

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.

Published Date: February 2007

Page Count: 40

Unit Price: US$ 750

Site License: US$3500

Format: Electronic PDF copy
Table of Contents

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