The World Health Organization (WHO) on Wednesday added seven HIV/AIDS medicines to its list of prequalified medicines, and the newly listed medicines have received approval or tentative approval by the United States Food and Drug Administration (FDA).
The medicines are six antiretrovirals from Indian generic manufacturer Aurobindo and one from Aspen, South Africa.
The additions followed an agreement signed earlier this year between WHO and FDA to facilitate the exchange of quality-related information on HIV/AIDS medicines for procurement, WHO said in a statement.
WHO's inclusion of the FDA approved medicines adds value to the process by providing a wider selection of products of assured quality into a single comprehensive list, it added.
"The listing of FDA tentative approvals makes the task of procurement agencies easier so that they only need to consult one list when buying," said Lembit Rago, head of WHO's prequalification project.
"In the long term, the US FDA tentative approval process for antiretrovirals can also help to reduce WHO's work load in prequalifying medicines, thus allowing the health agency to devote more attention to products that have not been assessed by any other stringent regulatory agency," he said.
According to WHO, there are no major differences between the FDA and WHO medicines assessment systems.
The standards against which the WHO assessment teams evaluate both the quality specifications of medicines and the manufacturing sites are based on the principles and practices agreed by the world's leading regulatory agencies, including the FDA, and adopted by the WHO Expert Committee on Specification for Pharmaceutical Preparations.