Market Authorization 101

7 January 2020

This slide deck outlines a potential path of market authorization for the dapivirine vaginal ring. It clarifies the necessary regulatory, normative guidance, and policy steps at the global and country levels that would be needed to support ring introduction. This Market Authorization 101 deck is intended to illustrate the ring pathway to market and assist key stakeholders in considering which steps are needed to support this process.

Featured Resources

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PrEP Ring for Adolescent Girls and Youth Women: Summary of research findings

This brief outlines findings from a recent study which has published critical new data on use of the dapivirine vaginal ring (PrEP ring or ring) among adolescent girls and young women in eastern and southern Africa, offering evidence that the ring is safe, effective, and highly acceptable.

Presentation

PrEP Ring Safety Data in Adolescent Girls and Youth Women (AGYW)

This slide deck presents emerging evidence to support conversations on expanding pre-exposure prophylaxis (PrEP) ring access for adolescent girls and young women (AGYW) in policy and programmatic rollout.

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PrEP Ring for Pregnant and Breastfeeding Women: Summary of research findings in eastern and southern Africa

This brief outlines findings from recent studies which have published critical new data on use of the dapivirine vaginal ring (PrEP ring or ring) among pregnant and breastfeeding people in eastern and southern Africa, offering evidence that the PrEP ring is a safe and effective HIV prevention method for a broader population than was initially…

Presentation

PrEP Ring Safety Data in Pregnant and Breastfeeding Women

This slide deck presents emerging evidence to support conversations on expanding pre-exposure prophylaxis (PrEP) ring access for pregnant and breastfeeding women (PBFW) in policy and programmatic rollout.

Spreadsheet

MOSAIC – PrEP Site Implementation and New Product Readiness Assessment Tool

This tool is intended to provide insight into the current state of PrEP services and to identify critical barriers and facilitators to PrEP implementation. Additionally, this tool is designed to inform preparations for new PrEP product introduction (CAB PrEP, PrEP ring, or both) according to national priorities. Findings from readiness assessment visits using this tool…

PrEP for Pregnant and Breastfeeding People: Advocacy, Policy, and Programmatic Tools

Evidence shows that offering PrEP is a safe and effective HIV prevention strategy for pregnant and breastfeeding people. Guidance from the World Health Organization (WHO) supports provision of PrEP to pregnant and breastfeeding people (PBFP) who are at continuing substantial risk of HIV infection. Evidence has shown that people have an increased need for HIV…

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Private Sector Market Assessment: Eswatini

This market assessment explores the opportunities and barriers to leveraging private sector channels to expand access to new and existing pre-exposure prophylaxis (PrEP) methods, including oral PrEP, the dapivirine vaginal ring (PrEP ring), and long acting cabotegravir (CAB PrEP) in Eswatini.

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CATALYST Interim Learnings (May-November 2023)

In this first interim analysis, the MOSAIC team provides key learnings from preparing for the delivery of PrEP choice, a summary of challenges experienced in implementing the enhanced service delivery model and the solutions introduced, programmatic considerations for countries preparing to introduce new PrEP methods, and a list of publicly accessible tools and resources used…

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Dapivirine Vaginal Ring Clinical Training for Providers

This clinical training, developed by the MOSAIC consortium for use in the CATALYST study, can be used to train providers to offer the dapivirine vaginal ring.

External Link

ICAP PrEP Package for Providers: PrEParing for Choice

ICAP’s PrEP Package for Providers: PrEParing for Choice was developed by ICAP at Columbia University to promote the introduction and implementation of multiple PrEP products. The material is designed to capacitate health care teams with the knowledge and skills to counsel clients about PrEP and PrEP options, conduct effective PrEP initiation visits, and monitor and…