How the concept of WHO-listed authorities will change international procurement policies for medicines

The concept of stringent regulatory authorities (SRAs) is due to be replaced in the middle or long-term by the concept of ‘WHO-listed authority’ (WLA). The WHO started in 2016 a formal Global Benchmarking for national regulatory authorities
(NRAs), incorporating the concepts of ‘maturity level’ on a 1–4 scale, and of ‘reliance’. Reaching a maturity level 3 is a step toward possible WLA designation.
The major international purchasers of medicines currently rely on marketing authorisations issued by SRAs and on approval (listing) by WHO prequalification
programme. We contend that the future WLAs should be equated to and trusted like SRA for the scope of designation.
The time is also ripe for a reflection on whether and how procurement policies can incorporate the concept of ‘maturity level’, based on a thoughtful, stepwise
approach accompanied by rigorous monitoring and evaluation. By doing so, the efforts of NRAs to reach maturity levels 3 and 4 would be fairly acknowledged;
and there would be an incentive for other countries to invest in the development of their NRAs and to be listed as WLA.

Publication year:2022

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