China considers drug approval reforms to spur research

Saying the current drug approval process in China "does not suit the development of the drug making industry," the head of China's Food and Drug Administration said the mainland's government is considering reforms to the drug examination and approval process, according to a report by state-owned Xinhua and carried on the website.

Bi Jingquan

CFDA head Bi Jingquan made the comments at a briefing session for the National People's Congress Standing Committee.

"The quality of some generic drugs lags far behind their international counterparts," Bi said in the report, adding the problem could be fixed by changing the approval system.

Reforms being considered would allow research agencies and researchers themselves to apply for drug approvals where previously they were required to transfer their findings to drug producers.

Bi said the rules forcing researchers to transfer their findings put them at a disadvantage and gave them no incentive to come up with new and innovative drugs because they couldn't share in the rewards after the drugs were in the market.

Officials also told Xinhua the reforms are an attempt to bring China closer to developed countries in drug production and also to promote Chinese-made generics. CFDA officials said in a release that China would develop a pilot system to improve generic production in the country and search for ways to improve the generic approval process.

- here's the story from
- here's the CFDA release on the draft decision (Chinese language)