4 Nov 2009 08:55

China must adopt global drug R&D standards - SFDA official

Beijing. November 4. INTERFAX-CHINA - China needs to ensure its drug research and development (R &D ) regulations are in line with international standards as drug development increasingly takes place in a globalized environment, according to a State Food and Drug Administration (SFDA) official.

"The globalization of drug R & D has brought innovative drugs to the Chinese market and is gradually shifting the R & D process into China. Therefore, the world needs to cooperate more in formulating drug R & D regulations and standards," Zhang Wei, director of the SFDA's drug registration department, said at the 1st Drug Information Association (DIA) China Annual Meeting held in Beijing on Nov. 2 and Nov. 3?

According to Zhang, China offers a low-cost clinical trial environment at a time when clinical trial costs are steadily rising in developed countries. However, China is also facing obstacles in hosting clinical trials due to differences in drug R & D and clinical trials regulations across different countries, especially in multi-regional clinical trials.

To this end, DIA aims to promote a dialogue between government regulatory agencies, industry practitioners and academics to facilitate knowledge exchange, Jeffrey Sherman, president of the global non-profit biopharmaceutical association, told Interfax.

According to statistics from the U.S. National Institutes of Health, China is emerging as a preferred site for clinical trials. Between 2004 and 2008, the number of clinical trials which began third phase testing in China grew by an average of 39 percent year-on-year, nearly eight times more than the global average.