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International Clinical Trials

China: Delivering Clinical Excellence

OVERVIEW OF THE DRUG MARKET

2008 was one of the busiest years for China with regards to the establishment and revision of drug and medical policies. The pharmaceutical industries again began to thrive after a depression lasting several years. The aggregate amount spent by hospitals on purchasing drugs grew by 32.76 per cent year-on-year in the first half of 2008, four per cent higher than in 2007. The accumulated purchasing amount of medical products over seven classifications amounted to US$28.8 billion during the period of January to July all over the country, which is a yearly growth of 13.15 per cent.

The top 10 drugs used throughout hospitals indicate that anti-tumour drugs, cardiovascular drugs and digestive system drugs have been gaining more and more attention in clinical use.

OVERVIEW OF DRUG APPLICATION SYSTEM OF CHINA

The China State Food and Drug Administration (SFDA) divides chemical drugs into six categories according to world pharmaceutical development status. Those drugs not yet launched onto the market of any country are classified as category 1 or 2, and are regarded as new drugs. Clinical trials from Phase I to Phase III are needed before drugs can be launched, followed by a large sample Phase IV trial conducted soon after they are released onto the market according to regulations. Category 3 to Category 5 are those drugs which are launched in markets other than China, although they are also administrated as new drugs with simplified clinical trial procedures compared to those in Category 1 or 2. Generic drugs are considered to be Category 6. Although products of this category are not new, a Bio-equivalence (BE) study is required before they can be launched onto the market.

Drug development in China runs along the same lines as in other countries, consisting of several steps, including compound screening, preclinical research, clinical trial application, clinical trial, registration application, launch and marketing, and so on. The steps with considerable differences to developed nations are ‘approval system for clinical trial’ and ‘certification system for clinical trial institution’.


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Dr Xunting Zeng has decades of experience in the field of clinical trials. Dr Zeng received his PhD at Kansai Medical University, Osaka, Japan, before going on to work as a Special Investigator at the International Medical Center of Japan. Several years later he joined the InCROM Group, a Japanese-based international contract research organisation. Dr Zeng is currently General Manager of InCROM China.

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Dr Xunting Zeng
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