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China-made Tamiflu Approved for Production

A Chinese company has been approved by the State Food and Drug Administration (SFDA) to produce the anti-flu drug, Tamiflu, sources with the SFDA said Tuesday.


Tamiflu is an anti-viral drug which is considered the most effective treatment available to counter the H5N1 strain of bird flu.


Tests showed the domestic Tamiflu was as effective and safe on humans as the imported version, said an official with the SFDA.


It would be used to treat type A and B flu in adults and children over the age of one, and to prevent type A and B flu in adults and youngsters over the age of 13.


Buyers must have a doctor's prescription and take the drug under guidance, the official said.


Swiss pharmaceutical firm Roche Swiss granted a sub-license for the production of Tamiflu to the Shanghai Pharmaceutical Group in December. Clinical studies on the effectiveness of Tamiflu began in March.


Tamiflu was invented by US-based Gilead and licensed to Roche in 1996. Roche, based in Basel, now has exclusive worldwide rights for the manufacturing and marketing of the medicine.


The latest bird flu outbreak occurred in remote Xinjiang Uygur Autonomous Region early this month has been contained, with more than 17,100 poultry slaughtered. The country has reported more than 30 outbreaks in birds since last October.


China has reported 18 cases of human infection of bird flu since last November with 12 fatalities. The last case was confirmed on April 27.


Globally, 225 human infections, including 128 deaths, have been recorded by the World Health Organization (WHO), according to the WHO website.


The central government is strengthening prevention and control of bird flu although no new human cases have been confirmed for more than a month, a health official said Monday.


"We are still keeping a close eye on bird flu and have strengthened scientific research and nationwide surveillance," said Ministry of Health spokesman Mao Qun'an at a press conference.


So far, the virus outside of the human infections had shown no sign of mutation, and human-to-human transmission was still unproved in clinical studies, he said.


China's Ministry of Agriculture also issued an emergency order Monday for local governments to tighten controls over poultry stocks to prevent bird flu contamination by migratory birds.


The order calls for strict supervision of areas below all possible flight paths of migratory birds, lakes and other sites with a record of bird flu infection.


Farmers living in these areas are advised to keep their poultry in coops to avoid contact with the migratory birds.


The ministry also ordered immediate reporting of any dead poultry or wild birds to county-level animal epidemic prevention agencies, and suspected cases must be reported to the state-level bird flu laboratories.


Meanwhile, the Chinese government was working closely with international organizations in fighting bird flu.


Last week, China joined in a pandemic response exercise in prevention and control of bird flu held by the Asia Pacific Economic Cooperation (APEC), which aimed to test the preparations of the organization's members for an epidemic in terms of information sharing, technological support and prevention of cross-border spread.


On Tuesday, a center was set up by China and the World Health Organization to fight infectious diseases including influenza.


The center, based in south China's Guangdong Province, will become a training base of southern provinces of China and may expand to become a training center for neighboring countries, according to WHO.


It will also work with the Guangdong CDC laboratory to detect emerging infectious diseases and carry out epidemiological research and study the origin of diseases that can be spread from animals.


(Xinhua News Agency June 14, 2006)



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