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The U.S. Food and Drug Administration (USFDA) and World Health
Organization (WHO) have launched a joint pilot initiative to speed
up approval of HIV medicines for supply to developing
countries20. The FDA will share documents on HIV drug
applications that have been approved or tentatively approved by the
agency under the US President's Emergency Plan for AIDS Relief
(PEPFAR) with WHO.
About Pilot Initiative
In the pilot, called the Collaborative Registration
Procedure-Lite (CRP-Lite), the FDA will provide the WHO,
Prequalification programme with reviews of HIV drug applications,
initially for one or two medicines. WHO will then use the FDA's
reviews to expedite its own assessments of the medicines, producing
reviews which can then be shared with regulators in
resource-limited countries to speed up their own regulatory review
processes— making lifesaving drugs available to patients
faster.
This pilot builds on the Collaborative Registration Procedure
introduced by WHO in 2014, which has seen incountry registration
times reduce from over two years to less than 90 days for over 300
products in 36 countries in Africa, Asia, the Caribbean and Eastern
Europe.
These initiatives are important because most regulatory
authorities in low-income countries are under-resourced and
stretched, resulting in slow approvals of medicines that are
desperately needed by patients.
About PEPFAR21
PEPFAR was launched in 2003 to address the global HIV/AIDS
crisis by using U.S. funds to purchase, at low cost, antiretroviral
therapies, including new combinations and formulations of
medicines, for treatment in countries with limited resources that
were hard-hit by the epidemic. Since 2004, the FDA has approved or
tentatively approved 211 antiretroviral drug applications for use
in PEPFAR partner countries and 193 of those are still available
for treatment. The FDA-reviewed products are currently being used
to treat over 14 million HIV patients globally (or about 38 percent
of the total global population living with HIV). In addition,
because of PEPFAR's ARV-supported programme to prevent
mother-to-child transmission, more than 2.4 million babies have
been born HIV-free who could have otherwise been infected.
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