Essential medicines and health products

New FDA-WHO joint pilot to accelerate access to HIV medicines

The U.S. Food and Drug Administration (FDA) and WHO have launched a joint pilot initiative to speed up approval of HIV medicines for supply to developing countries. 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).

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 in-country 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.