In support of the U.S. Government’s global response to the COVID-19 pandemic, the United States Agency for International Development (USAID) introduced the test-to-treat initiative (T2T) in ten priority countries for populations at high risk of severe illness from COVID-19 in May 2022. PQM+ supports the T2T initiative by facilitating product registration of COVID-19 therapeutics in the countries identified by USAID; which are: Bangladesh, Botswana, Côte d'Ivoire, El Salvador, Ghana, Lesotho, Malawi, Mozambique, Rwanda, and Senegal.
PQM+ developed the model dossier guidance for facilitated regulatory pathways (FRPs) used during public health emergencies or for unmet medical needs. The guidance outlines various FRP pathways used by stringent regulatory authorities (SRAs) and the differences in requirements or review processes, specifically as it relates to risk-benefit considerations, post approval requirements, and modified post-market commitments. The model also describes reliance FRPs that can be adapted by medicines regulatory authorities (MRAs) in low- and middle-income countries (LMICs). The guidance is provided for standardized dossier submission formats, legal and regulatory considerations, priority review areas for LMICs, selection of an approval pathway, and how to overcome variable requirements in structured product labeling (SPL) and summary of product characteristics (SmPC) package inserts.
The intended uses and audiences of the model dossier include:
- As a model dossier applicable to various approval pathways that NMRAs can adapt for use and implementation during a health emergency or for an unmet medical need.
- As a guidance for manufacturers to navigate different approval pathways to facilitate dossier compilation and submission.
- To provide an adaptive common technical document (CTD) format that would be acceptable in a health emergency or for an unmet need for a majority of NMRAs in LMICs.
- To provide alternatives to redundant and non-critical review requirements when utilizing reliance pathways which hinge on reviews conducted by SRAs.
