Learning about Expanded Access and Potential of the Levonorgestrel Intrauterine System (LEAP LNG-IUS): Regulatory Matrix

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NOTE: This tool is an appendix to a report, the LEAP LNG-IUS Regulatory Assessment. Please find this here

Background: With funding from the Bill & Melinda Gates Foundation, FHI 360 and partners Population Services International (PSI) and WCG Cares are implementing the Learning about Expanded Access and Potential of the LNG-IUS (LEAP LNG-IUS) Initiative. The project is intended to help determine if and how expanded access to the levonorgestrel intrauterine system (LNG-IUS) — a long-acting contraceptive — could increase contraceptive use and continuation rates in sub-Saharan Africa. As part of the project, a regulatory assessment was conducted in 2018 by WCG Cares and FHI 360. The goal of the assessment was to identify potential strategies to expedite national registrations of LNG-IUS product(s) in Family Planning 2020 (FP2020) countries. Results of the assessment are available in a final report.