WHO Plans New Fees For IVD Prequalification In Early 2018
A new fee structure for the prequalification of in vitro diagnostics by the World Health Organization is expected to come into effect in early 2018 following the introduction of a fee-for-service framework for medicines and vaccines in January 2017.
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A new financing arrangement due to take effect in January 2017 will see manufacturers paying fees for the World Health Organization’s prequalification program in an effort to give it a firmer footing in the long term. While manufacturers have welcomed the new fee structure, the NGO Health Action International says safeguards will be needed to ensure regulation remains robust.
Diagnostics are assessed by the World Health Organization to support use for priority diseases in low-resource regions. Under a new WHO process, performance evaluations for IVDs may be initiated at a much earlier stage than is currently allowed.
The World Health Organization has issued draft guidance on what changes relating to IVDs that fall under its prequalification program manufacturers must report to the WHO, what changes do not need reporting, and what changes might require a new application for prequalification1.