[Ip-health] WHO Statement on US Proposal for Rapid Review of Fixed Dose Combinations

[Mike Palmedo]

http://biz.yahoo.com/prnews/040518/cntu007_1.html

Press Release    Source: World Health Organization

Statement of the World Health Organization on United States Proposal for
Rapid Review of Fixed Dose Combinations
Tuesday May 18, 5:40 am ET

GENEVA, May 18 /Xinhua-PRNewswire/ -- 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: +41-79-239-2366
Email:  boltons@who.int

Iain Simpson, Communications Officer,
Office of the Director-General,
Tel:    +41-22-791-3215
Mobile: +41-79-475-5534
Email:  simpsoni@who.int