WHO-FDA Pilot to Increase Patient Access to HIV Drugs in Resource-limited Countries

Regulatory NewsRegulatory News
| 30 November 2018 | By Ana Mulero 

The World Health Organization (WHO) forged a new partnership with the US Food and Drug Administration (FDA) to pilot an information sharing initiative for HIV drug applications.

The plan was revealed Friday as part of the US government’s 15-year-old initiative known as the President’s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR bridges the gap between FDA and WHO’s prequalification unit for the purposes of approving or tentatively approving antiretroviral therapies.

The initial pilot will be called the Collaborative Registration Procedure-Lite (CRP-Lite). Under the CRP-Lite pilot, the US agency aims to expedite the regulatory review process for drugs intended for HIV treatment and provide WHO with “minimally-redacted reviews of one or two HIV drug applications.”

WHO is charged with using the reviews provided by FDA to generate review dossiers that can be leveraged in countries with limited resources to independently expedite their own review processes.

“FDA has played an important role in supporting PEPFAR and the agency remains committed to doing what we can to facilitate timely access to these essential medicines,” said Anna Abram, FDA’s deputy commissioner for policy, planning, legislation and analysis. “The pilot will minimize duplication of efforts by the FDA and the WHO and help regulatory authorities in nations with limited resources make decisions faster on life-saving HIV drugs for patients with this devastating, but treatable disease.”

The US agency provided current statistics on its work under PEPFAR since 2004. These include 211 antiretroviral drug applications approved or tentatively approved for use in PEPFAR partner countries.



© 2022 Regulatory Affairs Professionals Society.

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