Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities

The Operational guidance for evaluating and publicly designating regulatory authorities as WHO-listed authorities provides procedural information (processes, steps and timelines) and general considerations related to the evaluation and listing of a regulatory authority as a WHO Listed Authority (WLA).  The guidance also describes the process and criteria for renewal, re-evaluation and possible delisting, the role and responsibilities of the WLA advisory group and the undertakings of WHO and eligible regulatory authorities.

Operational and technical details of the performance evaluation to be conducted for each regulatory function to achieve listing are described in the interim manual for the performance evaluation of regulatory authorities seeking the designation as WHO-listed authorities.

This guidance and the performance evaluation manual were developed following international consultative meetings with member states and interested stakeholders, broad public consultations and technical working group discussions.