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China to Fast-Track Approval of Human Vaccines for Bird Flu

Posted on: Sunday, 20 November 2005, 03:02 CST

Text of report in English by official Chinese news agency Xinhua (New China News Agency)

Beijing, 20 November: Human vaccines for bird flu and other epidemics will go through fast-track government examination procedures for timely production to combat the virus, according to a notice issued by China's State Food and Drug Administration (SFDA) on Saturday [19 November].

SFDA has initiated a set of special procedures to quicken the examination and approval of medicines for treating epidemics that trigger public health concern, said the notice.

Human-use vaccines for bird flu developed by Chinese companies will enjoy the privilege, while SFDA will conduct feasibility study before the application is filed and learn about the progress of the medicine's research and development in the early stage of medicine registration application.

Processing application, on-the-spot check, technological examination and evaluation, registration examination and follow-up monitoring of the medicines will be carried out immediately after receiving the registration application, according to the notice.

Beijing-based vaccine producer Sinovac Biotech, the first in the world to develop a SARS (severe acute respiratory syndrome) vaccine, has applied to SFDA for human clinical tests on human-use bird flu vaccine. The company said it would start mass production once the clinical trials are successful.

Source: BBC Monitoring Asia Pacific

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