Overview

Timely access to quality-assured in vitro diagnostic (IVD) medical devices is essential to support preparedness and response efforts during public health emergencies. To facilitate timely availability of priority in vitro diagnostic (IVD) medical devices during public health emergencies, the WHO established Emergency Use Listing (EUL) procedure as a risk-based assessment pathway that evaluates the available evidence on the quality, safety, and performance of IVDs intended for emergency use, where comprehensive data required for routine prequalification or market authorization may not yet be available. The outcome of the EUL assists United Nations procurement agencies and Member States in determining the acceptability of specific products for use during emergency situations.

Building on the success of regulatory reliance mechanisms, including the WHO Collaborative Registration Procedure (CRP), WHO has developed the WHO Facilitated Procedure (WHO-FP) to support National Regulatory Authorities (NRAs) in accelerating the national authorization or listing of WHO Emergency Use Listed IVDs. Subject to the manufacturer's consent and appropriate confidentiality arrangements, WHO shares confidential EUL assessment information with participating NRAs to facilitate reliance on WHO's scientific assessment while maintaining national regulatory decision-making authority and sovereignty.

By participating in the WHO Facilitated Procedure (WHO-FP), NRAs can leverage WHO Emergency Use Listing (EUL) assessment outcomes to support timely regulatory decision making, streamline authorization processes, reduce duplication of technical assessments, strengthen regulatory capacity, and facilitate access to quality-assured IVDs during public health emergencies. A flowchart summarizing the WHO WHO-FP along with the NRA Confidentiality Undertaking is provided below.

If you have any questions, please contact crp@who.int.

CONFIDENTIALITY UNDERTAKING BY NATIONAL REGULATORY AUTHORITIES (FOR MPOX PRODUCTS ONLY)

CONFIDENTIALITY UNDERTAKING BY NATIONAL REGULATORY AUTHORITIES (FOR BDBV PRODUCTS ONLY)