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China streamlines import of HIV drugs

China's State Food and Drug Administration will streamline approval procedures for importing drugs to treat the estimated 85,000 HIV patients in the country

China's State Food and Drug Administration (SFDA) will streamline approval procedures for importing drugs to treat the estimated 85,000 AIDS patients in the country.

The approval was based on the release of a report into HIV/AIDS prevalence and prevention assessment in the region for 2007 on 29 November, which stated that about 700,000 people in the country are living with AIDS and HIV.

Zhang Wei, director with the SFDA's drug registration department, said that a streamlined approval method had been adopted for imports of drugs which showed significant clinical effects in treating diseases such as AIDS and cancer.

A regulation on drug approval was also amended in July 2007, making procedures more transparent and efficient and could see certain procedures going faster in certain cases.

To date, only seven HIV drugs are prescribed for first-line anti-retroviral treatment in China, with 37,497 AIDS patients receiving free treatment through government aid programmes. About 10 percent of patients on the first-line treatment, however, develop resistance after taking the drugs for one year and have to switch to the second-line drugs to survive, according to the Chinese Health Ministry.

Approval for the import of US-based Gilead Science's TDF, a drug in the second line of triple therapy in HIV, is currently under way and should be completed in time. Gliead filed the required application in August 2007.

Gilead markets TDF in the US under the brand name Viread (tenofovir) and as a part of its Atripla (efavirenz/ tenofovir/ emtricitabine) combination product. The SFDA has also approved the import of lopinavir/ritonavir, manufactured by US-based Abbott.

The Ministry of Health launched a pilot scheme on second-line therapy in Henan, Anhui and Hubei provinces, which will eventually be expanded to the whole country.

Global sales for Bristol-Myers Squibb (BMS) and Gilead's combinations treatments Atripla and Truvada racked up sales of USD 650m and USD 1.1bn respectively during the first nine months of 2007.

3rd December 2007


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