WHO-EUL-Facilitated Procedure (WHO EUL-FP) for in vitro diagnostics for SARS-CoV-2
In May 2021, WHO introduced the Facilitated Procedure for in vitro diagnostics (IVDs) listed by WHO (WHO EUL-FP) for SARS-CoV-2. The Procedure facilitates accelerated national decisions of SARS-C0V-2 IVDs as a part of the WHO’s strategic response to combat the COVID-19 pandemic. Accelerating national decisions and subsequent use of quality-assured SARS-COV-2 testing tools facilitates timely access and management of COVID-19 at the country level. Like the collaborative registration procedure, WHO will share WHO-EUL assessment outcomes for SARS-CoV-2 IVDs with National Regulatory Authorities (NRAs) to accelerate in-country listing/authorization of these critical products during the pandemic. The Procedure is open to all SARS-CoV02 IVDs manufacturers with a valid EUL from WHO and all WHO Member States.
Manufacturers of SARS-CoV-2 IVDs with a valid EUL from WHO will provide written consent to allow WHO to share the assessment outcomes with the WHO Member States. The WHO Member States, through the NRAs or Ministries of Health, as applicable, will sign a confidentiality agreement to access the confidential information from WHO. Only products with written consent from the manufacturer and listed will be shared with the NRAs.
WHO Member States and manufacturers are encouraged to maximize this opportunity to facilitate timely regulatory decisions for listing, emergency use authorization, or importation of quality-assured SARS-CoV-2 IVDs during the pandemic.
Procedure Documents for WHO EUL-FP for SARs-COV-2 virus
French version also available from link below.
Annex 1: Confidentiality Agreement with NRAs
Arabic, French and Russian available from link below.