Chinese Pharmaceutical Guidebook Series

Preface

China possesses a fourth population in the world and has one of the largest drug markets round the world. By 2003, sales on the Chinese drug market have reached $6.1 billion dollars, an increase of 2.3 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 2003, 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 writes out the China Pharmaceutical Guidebook Series. 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.

- Chinese Latest 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.