The top food and drug agency is streamlining approval procedures
for importing drugs to treat the estimated 85,000 patients in the
country suffering from full-blown AIDS.
The move came after China released its HIV/AIDS prevalence and
prevention assessment report for this year on Thursday, which
stated that about 700,000 people in the country are living with
AIDS and the HIV virus which causes the disease.
Zhang Wei, director with the drug registration department of the
State Food and Drug Administration (SFDA), said his administration
has always attached great importance to importing AIDS drugs.
"The approval work (for imported AIDS drugs) has never stopped,"
Zhang said.
He said a streamlined approval method has been adopted for
imports of drugs that show significant clinical effects in treating
diseases such as AIDS and cancer.
A regulation on drug approval was also amended in July making
procedures more transparent and efficient, which could see certain
procedures going faster in special cases.
It costs 120 working days to register an AIDS drug compared with
150 for most others, Zhang said.
Approval for the import of TDF, a key drug in the second line of
anti-retroviral treatment also known as the cocktail therapy for
AIDS, is currently under way and is expected to be completed in
time, he said.
The United States-based Gliead, the drug's developer, filed the
required application in August, said Zhang.
So far, only seven kinds of AIDS drugs mainly prescribed for
first-line anti-retroviral treatment are available in China, with
37,497 AIDS patients reportedly getting free treatment with
government aid.
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, said Hao Yao,
deputy director with the disease control department of the Health
Ministry.
To reduce the drug resistance also faced by AIDS patients in
other countries, Hao strongly urged Chinese patients to stick to
their treatment as many kinds of drugs in the second-line cocktail
treatment such as TDF are still unavailable here and have to be
imported from foreign countries.
"We are aware of the pressing issues and are considering further
measures and policies," Zhang said.
Last week, the SFDA approved the import of Lopinavir/ritonavir,
produced by the US-based Abbott Laboratories, which is also a
crucial part of the second-line cocktail treatment.
In another development, the Ministry of Health has launched a
pilot scheme on second-line therapy in Henan, Anhui and Hubei
provinces, said Hao.
"This will be further expanded to the whole country," he
said.
(China Daily December 3, 2007)