Technical Advisory Group for Snake Antivenom Immunoglobulin Listing (TAG-SAIL)
The Technical Advisory Group for Snake Antivenom Immunoglobulin Listing (TAG-SAIL) is an independent advisory group that will provide a recommendation to WHO about whether an antivenom can be recommended for procurement under the snake antivenoms risk-benefit procedure, and if so, under what conditions.
The TAG-SAIL shall have the following functions:
- To undertake a desktop review and risk-benefit assessment of the product dossiers submitted to the WHO Secretariat by respective manufacturers and prepare product dossier reports for WHO indicating specific deficiencies, data gaps and other areas of concern.
- To subsequently consider the results of independent laboratory analysis of antivenom products, and the outcomes of Good Manufacturing Practice (GMP) inspections.
- For each snake antivenom product submitted for WHO assessment, to conduct a risk-benefit assessment of such product’s potential use for the treatment of the abovementioned WHO category 1 medically important snake species.
- Based on the findings of the product dossier reviews, laboratory analyses and GMP inspections, to make recommendations to WHO on whether the assessed antivenoms should be listed as recommended product under the SAIL procedure, and under what conditions.
- To advise on formulating conditions for the listing should the decision be positive. Conditions will include detailed post-listing commitments from the manufacturer.
The TAG-SAIL comprises up to twelve members, who serve in their personal capacity and represent a broad range of disciplines encompassing many aspects of biologicals manufacturing, quality control and regulation, as well as clinical medicine and veterinary medicine.
Members are recruited and selected as acknowledged experts from around the world in their respective fields or work. They are appointed for a term of two years and are eligible for reappointment.