FDA to share HIV drug information with WHO

Published: December 01, 2018 14:55:31 | Updated: December 04, 2018 12:54:32


The United States Food and Drug Administration (FDA) announced Friday a plan to work with the World Health Organization (WHO) to expedite review of HIV drug applications.

FDA decided to pilot a process to 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), an HIV/AIDS aid program which started 15 years ago.

In this initial pilot called the Collaborative Registration Procedure-Lite (CRP-Lite), FDA will provide the WHO pre-qualification of medicines program (WHO/PQP) with minimally-redacted reviews of one or two HIV drug applications, upon the applicants' permission.

The WHO/PQP can use the FDA's reviews to expedite its own regulatory decision making, producing review dossiers which can in turn be shared with regulators in resource limited countries to speed up their own regulatory review processes, according to FDA.

Such a procedure may make lifesaving drugs available to patients who need them the most.

PEPFAR was launched in 2003 to address the global HIV/AIDS crisis by using American funds to purchase antiretroviral therapies at low cost.

Antiretroviral treatment, which usually involves a combination of three drugs, can dramatically reduce the severity of illnesses associated with HIV infection, reports Xinhua.

Since 2004, 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. Those medicines are currently being used to treat over 14 million patients with HIV globally.

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