WHO Drafts Policy on Designating Regulators as Listed Authorities
With an eye toward strengthening the regulation of medical products in underserved regions, the World Health Organization (WHO) late last year published a draft policy to establish a framework for ensuring certain medical product regulators can be globally recognized as meeting WHO and other international standards and practices.The policy, expected to be finalized by the end of this year, is part of a shift from the term “stringent regulatory authority” to “WHO-Listed Authority” (WLA). Under the framework, if a regulator passes a WLA evaluation process, the regulator will be publicly listed alongside the scope of the designation (product types and/or regulatory functions); evidence reviewed and process undertaken to support the listing; and the period of validity of the listing. A listing will normally be valid for a period of at least five years, the draft says, provided there have not been any changes that could negatively impact the regulator's listing.
Building off a concept note published last summer, the proposed framework uses an evaluation tool (known as Global Benchmarking Tool or GBT) to generate and analyze the evidence of a regulatory system’s performance. WHO is also developing a system for evaluating the performance of regional regulatory networks or systems.
Only regulators with a maturity level 3 authority will be eligible for consideration as a WLA.
WHO also clarified that the designation of WLAs is meant to substantiate their maturity and performance as defined by the GBT and the performance evaluation process. But the framework is not meant to make any inference regarding the maturity or performance of a regulatory authority that has not been evaluated by WHO.
“Should it become evident during the course of the combined benchmarking-performance evaluation exercise that the regulatory authority is unlikely to meet requirements for listing within a 6 – 12 month timeframe from the start of the benchmarking-evaluation process, depending on the scope of designation, the authority would be invited to reapply at a later time once identified areas for improvement have been addressed,” the note from June said.
Draft Policy Evaluating and Publicly Designating Regulatory Authorities as WHO Listed Authorities