In the context of the WLA initiative, which is designed to provide a transparent and evidence-based pathway for regulatory authorities to be globally recognized as highly performing, the establishment of a Technical Advisory Group on WHO Listed Authorities (TAG-WLA) has been considered necessary to ensure impartiality and transparency of the WLA decision-making process.
The main objective of the Advisory Group is to provide an independent advice on whether the listing/delisting recommendation of the WHO is supported by findings from the evaluation process, thereby providing an additional level of assurance that due process was followed.
The group is composed of 14 experts from six WHO regions, with broad range of expertise relevant to evaluating the performance of candidate WLAs, and a wide knowledge of and experience in regulatory systems for medicines, vaccines, or related fields.
The Regulation and Safety Unit serves as the secretariat of TAG-WLA.
In the exercise of their advisory function, members of TAG-WLA shall serve in their personal capacity, as international experts advising WHO exclusively; and in that capacity they respect the impartiality and independence required, are free of any real, potential or apparent conflicts of interest and provide WHO with the best possible advice. TAG members will not be remunerated for their participation in TAG-WLA; they are appointed to serve for a period of 3 years and are eligible for one reappointment.
The TAG-WLA will meet at least once a year, in person or through video- or tele-conference. Frequency may be adjusted by WHO as necessary. For more information please see the Terms of Reference of the TAG-WLA.
WHO shall provide the secretariat for the TAG, including necessary scientific, technical, administrative, and other support. The Regulation and Safety Unit (REG) under the Regulation and Prequalification (RPQ) Department, Access to Medicines and Health Products (MHP) Division of WHO serves as the secretariat of TAG-WLA.
List of members
Executive Director, Wits RHI, University of the Witwatersrand, Johannesburg, South Africa