China: a new era of innovation in drug development

The latest edition from Research and Markets' Clinical Trials Special Report Series breaks down China's clinical trials landscape and analyze the government investments that are making the country more attractive for inclusion in global drug development programs of pharma companies of all sizes.

China's State Food and Drug Administration (SFDA) has implemented regulatory reforms and invested in the domestic pharmaceutical sector to foster an innovative drug development community. Some of the reforms are also aimed at making China more attractive for inclusion in simultaneous global drug development programs for drug registration in China.

Big Pharma, according to the report, is now shifting development strategies to include China earlier in global drug development programs. Both sponsor companies and the SFDA are continuing to work on streamlining approval timelines. Investment in domestic pharma is already under way, and the SFDA has further clarified what constitutes a new drug in China.

More regulatory transparency

An important reform, the pre-Investigational New Drug Approval (IND) discussion with the SFDA, has helped create more transparency in the regulatory agency's approval process. Now, more global pharmaceutical companies are including China in their global drug development programs, not just for registration of drugs in the USA and Europe but also for registration in China, as they see this strategy becoming a more practical approach.

China's increasing participation in global drug development programs requires personnel who are experienced working at the global level. Moreover, Big Pharma has long-range plans for China, investing in R&D centers even during the economic downturn.

Further development is still needed at the investigative site, institutional review board and domestic contract research organization (CRO) levels to increase their ability to work at a global standard. China's growth has been steady, allowing the country to build capacity for such time when regulatory approval timelines comport with Western nations, the report notes.