Following the publication of a concept note and of the policy document on the evaluation and designation of regulatory authorities as WHO listed authorities (WLA), we invite you to review the draft working document “OPERATIONAL GUIDANCE: EVALUATING AND PUBLICLY DESIGNATING REGULATORY AUTHORITIES AS WHO-LISTED AUTHORITIES”.
The document was developed following several international meetings with Member States and interested stakeholders, as well as working group discussions attended by regulators and experts from all WHO regions. The Guidance provides details to operationalize the Policy document, by describing the process of evaluation and public designation of National Regulatory Authorities or Regional Regulatory Systems as WLA; illustrating procedures for renewals, re-evaluation and delisting; establishing steps, activities, timelines, and criteria of the Performance Evaluation Process, which complement the GBT and will be used by National Regulatory Authorities or Regional Regulatory Systems to reach and maintain listing.
Please use the dedicated form to provide your comments. Please send your comments to Hiiti Sillo (silloh@who.int) and kindly copy Anna Laura Salvati (salvatia@who.int).
Please note that the deadline to provide your comments is 30 September 2021. Only comments received by the deadline will be considered in the preparation of this draft working document.