WHO published a Concept Note entitled “A FRAMEWORK FOR EVALUATING AND PUBLICLY DESIGNATING REGULATORY AUTHORITIES AS WHO-LISTED AUTHORITIES”, which will be posted on the WHO Medicines website under Current Projects for public revision and comments  (https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_808_WHO_listed_authorities.pdf?ua=1).

This Concept Note presents a proposed definition for WHO-Listed Authorities (WLAs); procedures for designating a WLA; and the process for finalizing the definition and the procedures for putting the framework into place.

Given the wide interest in and implications associated with the definition and framework, WHO will adopt a multi-prong consultation process as outlined in this Concept Note.  Further details will be announced in due course.

All comments received by 17 July 2019 will be considered in the preparation of a draft policy and draft operational guidance documents. Please send any comments you may have to nra_admin@who.int , with a copy to Ms Claire Vogel (vogelc@who.int).