Under the LEAP LNG-IUS Initiative, Catalyst Global conducted a regulatory assessment with the goal of identifying potential strategies to expedite national registrations of LNG-IUS product(s) in Family Planning 2020 (FP2020) countries. Catalyst Global evaluated the potential benefit of pursuing LNG-IUS registrations via national-level regulatory authorities; through regional harmonization initiatives; and by following the World Health Organization (WHO) collaborative procedure, assessed three countries (Ghana, Ethiopia and Vietnam) as case studies.
Catalyst Global is also leveraging the registration of Medicine360’s hormonal IUS, AVIBELA, in Tanzania and Uganda* through the East African Community – Medicines Regulatory Harmonization (EAC-MRH) program in order to create access to AVIBELA in two additional countries (Uganda and Rwanda). The hormonal IUS is the first contraceptive product to be evaluated by the EAC-MRH program, and Catalyst Global will develop a case study based on this experience to share with the reproductive health community.
*Registration in Tanzania and Uganda is supported by the USAID-funded EECO project. Development of the case study is co-funded by the EECO project.
LNG-IUS
Uganda, Rwanda
2018 – 2022
Bill and Melinda Gates Foundation
“WCG Cares (now Catalyst Global) is one of our favorite partners. For our drug/device combination product, they streamline and simplify complex regulatory submissions in low-and-middle-income countries. Their expert support is delivered with transparency, collaboration, reliability, and creative problem-solving; all of which greatly increases the efficiency of our small team.”
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