Clinical Research In China
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0092-8615/97 Copyright 0 1997 Drug Information Association Inc.
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CLINICAL RESEARCH IN CHINA ELLICKWONG,PHD Area Medical Director. Astra East Asia Area Office, Singapore
China is a huge country with a population of around 1.2 billion people. It is estimated that there are two million physicians working in more than 100,OOO clinics and 65,000 hospitals throughout the country. Clinical research and pharmaceutical research and development (R&D)are predominantly being conducted in more than 400 research institutions and 130 medical schools. There are many good reasons for conducting clinical trials in China but foreign pharmaceutical companies are still concerned about their quality. A national guidelines for good clinical practice (GCP) is being finalized and it is expected that implementation of the guidelines will improve the quality of clinical trials and promote clinical trial activities in the country. Key Words: China; Clinical trial; Good clinical practice
INTRODUCTION
practice (GMP) standards. The Chinese authorities have started a process to modernize the factories with the aim that all will reach GMP standards by the year 2000. The Chinese pharmaceutical market in 1995 reached $5 billion. Since 1990 pharmaceutical sales have been growing at an annual rate of 11.9 % and they are expected to grow at a similar rate for the next five years. The per capita pharmaceutical consumption is still rather low at $4; it is expected to grow rapidly during the next few years. The huge market potential has attracted many multinational pharmaceutical companies as investors in China in recent years.
CHINA TODAY IS the dynamo of the Asia Pacific economic boom. In 1996, it had the third largest economy after the United States and Japan. The world bank predicts that by the year 2010, China will become the number one economy in the world. China has a vast amount of land, with a population of 1.2 billion people. Throughout China, there are 67,800 hospitals, 104,400 independent outpatient clinics, and about two million physicians. The country has about 130 medical schools, many with more than one teaching hospital. China has a large pharmaceutical industry with more than 3,000 pharmaceutical enterprises; many of them are foreign joint-venture companies. There are about 1,500 factories but most do not meet good manufacturing
PHARMACEUTICAL RESEARCH AND DEVELOPMENT IN CHINA There are more than 400 institutions involved in pharmaceutical research and development. In the past five years, they have developed and marketed 13 new chemical entities (NCEs). They have also spent great effort in producing a large number of imitations of foreign pharmaceuticals. Very recently, the State Science and Technology Commission announced that the Chinese government will
Presented at the DIA 32nd Annual Meeting “The Challenge of Worldwide Pharmaceutical Development in an Era of Regulatory Change: Accelerated Approval with Quality and Contained Cost,” June %13, 1996, San Diego, California. Reprint address:
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