8 Sep 2009 12:40

More Chinese GLP-certified labs meeting international standards, drug R & D taking off

By Karl Zhong

Shanghai. September 8. INTERFAX-CHINA - Pharmaceutical laboratories in China that have received Good Laboratory Practice certification from the State Food and Drug Administration are increasingly meeting international standards, and according to industry experts, China's pre-clinical research and associated standards will continue to rise thanks to government support.

In July this year, the U.S. Food and Drug Administration sent a team of experts to inspect the GLP-certified laboratories of the National Center for Safety Evaluation of Drugs under the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP), as well as Joinn Laboratories and Vital Bridge (China) Inc., which are both based in Beijing.

All laboratories met the FDA's inspection criteria, marking China's first such achievement.

"China's GLP standards are based on the GLP standards of developed countries, and are already quite comprehensive. The problem stems from whether these standards are strictly followed. Attaining the FDA's approval is a positive sign for these laboratories, which provide domestic and international companies with more options," You Lifen, clinical research manager of Taiho Pharmaceutical Co. Ltd., told Interfax on Sept. 7.

As such, Jiangsu Hengrui Pharmaceutical Co. Ltd. recently commissioned Joinn Laboratories to evaluate the safety of its new diabetes drug retagliptin. The drug has received FDA approval to commence clinical trials in the United States.

A number of contract research organizations (CRO), which conduct pre-clinical and clinical research, are also upgrading their laboratories and undergoing GLP certification as Chinese pharmaceutical manufacturers place more emphasis on the development of new drugs instead of generic drugs.

The move by CROs and laboratories to attain GLP certification has been spurred by the State Food and Drug Administration's introduction of a new regulation, which took effect Jan. 1, 2007, stating that all drug safety evaluation research on new drugs has to be made in GLP-certified laboratories in China. Since then, 37 GLP-certified laboratories have sprouted up around the country, of which 23 are affiliated to government agencies or other entities, 10 are domestic private CROs, and four are foreign CROs.

Pre-clinical research by Chinese companies is also largely taking off as the central government launched the National Key New Drug Creation Program in the second half of year. Investment of RMB 160 million ($23.43 million) will be put towards establishing eight GLP platforms that meet international standards in the country before 2011.

China has no intention of resting on its laurels and is working to further improve its GLP standards. The National Center for Safety Evaluation of Drugs, which has conducted safety evaluation research for 120 drugs, including 51 new drugs over the past 10 years, is conducting a project with the Japan International Cooperation Agency to do just that. Japan has sent more than 100 of its clinical trial experts to work in the center and China has sent over 20 experts to Japanese GLP-certified laboratories to undergo training.

According to a China Pharmaceutical News report, the NICPBP's director, Wang Junzhi, told a conference in April this year that the center aims to be involved in updating international GLP standards in the future as it is at the forefront of research in China.

In addition, China is in the process of entering a system where findings from its GLP-certified laboratories will be acknowledged by all the member countries of the Organization for Economic Co-operation and Development. The SFDA and the Ministry of Agriculture have attended working meetings related to this issue since February 2005.