Avibela Harmonized Labeling Initiative

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Harmonizing pharmaceutical product labeling (i.e., using identical labeling across multiple countries) can create time and cost efficiencies that benefit stakeholders across the value chain. Not surprisingly, the two largest global contraceptive procurers, USAID and UNFPA, strongly prefer that manufacturers supply products with harmonized labeling. Despite the clear benefits, there is little publicly available information for manufacturers and suppliers who want to pursue harmonized labeling of their products.

Under the LEAP Initiative, Impact RH360, WCG Cares, and FHI 360 developed a strategy to implement harmonized labeling for the hormonal IUD, Avibela. The project team is disseminating the learnings from this project to enable other suppliers to implement harmonized labeling for their products, if desired. The project team conducted extensive desk research on the labeling requirements issued by regulators in 21 LMICs and conducted 12 interviews with SMEs from procurement agencies, donors, manufacturers of similar products, and independent global regulatory consultancies.

The findings led Impact RH360 to develop a phased strategy for harmonized labeling for Avibela, in order to benefit from some level of harmonization in the relative short-term while allowing adequate time for the more extensive changes required for multi-language harmonized labeling.