WHO Statement on US proposal for Rapid Review of Fixed Dose Combinations
Geneva - The World Health Organization (WHO) welcomes the United States Government's announcement of its expedited process to review fixed-dose combination medicines and co-packaging of existing therapies for the treatment of HIV/AIDS in developing countries under programmes to be financed by the US.
"With the help of our partners we have developed simplified treatment approaches and prequalified fixed-dose combinations of antiretroviral drugs. Because of its importance to accelerating drug access, we will further develop and expand this initiative. I welcome the announcement made yesterday by the US government for a proposed rapid process for review of fixed-dose combinations and co-packaged products" said LEE Jong-wook, WHO Director-General. "It is essential that medicines used in treatment programmes financed by international donors be affordable and meet international quality, safety and efficacy requirements."
WHO established a Prequalification System in 2001 for approval of medicines for HIV/AIDS, malaria and tuberculosis and has already approved a number of fixed-dose combination antiretroviral medicines. This system was developed in consultation with the Member States of WHO and endorsed by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. It is operated in close cooperation with UNAIDS, UNICEF and UNFPA and is supported by the World Bank and the Global Fund to Fight AIDS, TB and Malaria.
For more information, please contact:
Samantha Bolton
Communications Officer, HIV Department
Tel: +41 22 791 1970 mobile: +41 79 2392366,
email: boltons@who.int; or
Iain Simpson
Communications Officer, Office of the Director-General
Tel: +41 22 791 3215, mobile: +41 79 475 5534,
email: simpsoni@who.int.