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.
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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