WHO-Listed Authority (WLA)
A Framework for evaluating and publicly designating regulatory authorities as WHO Listed Authorities (WLA)
The introduction of a framework for designating and publicly listing a regulatory authority as a WHO Listed Authority (WLA) responds to Member States requests to develop a transparent and evidence-based pathway for regulatory authorities operating at an advanced level of performance to be globally recognized, thereby replacing the procurement-oriented concept of stringent regulatory authorities.
Implementation of the WLA framework is intended to promote access and supply of safe, effective and quality medical products. The framework also provides for the optimal use of limited resources by facilitating reliance on the work products and decisions of trusted agencies in the decision-making of regulatory authorities, the WHO Prequalification Programme and procurement agencies.
The WLA initiative is also expected to foster regulatory convergence, harmonization of approaches and international cooperation, thus contributing to the improvement in good regulatory practices.
The GBT remains the foundation for classifying regulatory systems according to maturity level, providing a structured approach to assessing how well a regulatory system is configured to achieve desired results. The WLA performance evaluation framework provides a more detailed picture of how a regulatory system operates through an extended set of measurements targeting key regulatory outputs and consistent adherence to international standards and good regulatory practices.
As set out in the Policy, regulatory authorities that have attained an overall maturity level 3 classification are eligible for consideration as a WLA. In addition, following public consultation on the draft WLA Operational Guidance and discussions with Member States, transitional arrangements were developed that afford all regulatory authorities on the public WHO Interim list of National Regulatory Authorities the opportunity to be considered for WLA evaluation and listing - as reflected by their placement on a list of transitional WLAs (tWLAs).
The tWLA list replaces the WHO Interim list, which compiled categories of authorities recognized by WHO to have achieved levels of operation necessary for the regulation of medicines and/or vaccines. The tWLA list is valid for five years from the date of publication of the final WLA Operational Guidance, during which time the authorities will be evaluated against the requirements for designation as a WLA. A regulatory authority will move from the tWLA list to the permanent WLA list upon successful completion of the WLA evaluation process.
WHO will adopt a pragmatic and risk-based approach to evaluating performance that considers existing information and experience to ensure optimal use of resources and the efficiency of the process.
Links to the documents relevant to the WHO initiative for designation of WLAs are available on this page.
WHO will also be publishing additional documents and information related to the implementation of the WLA framework.
Note: The ultimate responsibility and decision for use of tWLA and WLA lists resides with the users (e.g., regulatory authorities, procurement agencies) and will depend on the specific context of its intended use. In no event shall the World Health Organization be liable for any damages arising from its use.
