The Global Fund, together with Unitaid and Stop TB’s Global Drug Facility (GDF), Invite TB Medicine Suppliers to Submit Dossiers for Needed TB Formulations
The Ad Hoc list prioritizes medicines most urgently in need of development: adult versions of pretomanid and delamanid for use in DR-TB treatment, fixed-dose formulations (FDC) of rifapentine/isoniazid/moxifloxacin to support shorter DS-TB treatment, and rifampicin-based 4-FDCs to address global supply constraints in DS-TB medicines. These, and other medicines are included in the 30th Round of Expressions of Interest (EOI) for the Global Fund Expert Review Panel (ERP). https://lnkd.in/emj6NshN
The Global Fund ERP plays a critical role in expediting availability of new TB formulations, providing an interim quality approval status that allows procurement by Global Fund, GDF, and others, whilst products undergo full review by the WHO Prequalification Programme.
Behind the scenes, the TB community collaboratively aligns on which products to recommend for inclusion in the Global Fund ERP EOI and which of these to prioritize for fastest possible assessment and availability. The WHO Global TB Programme and GDF conduct analyses and share draft recommendations with many stakeholders organized under the TB Procurement and Market-Shaping Action Team (TPMAT). Comments and discussion ensue until a consensus is reached on which products to recommend and prioritize. The TPMAT includes staff from WHO, the Global Fund, Stop TB Partnership’s GDF, Unitaid, Médecins Sans Frontières (MSF), Treatment Action Group (TAG), National TB Programmes, researchers, clinicians, implementers, and many more.
This is one step of many organized under the GDF-led TPMAT to proactively identify and address potential development, supply, and regulatory barriers to new TB product development. From horizon scanning to identify needed products, to sending supplier signals and developing supplier incentives, to supporting regulatory prioritization.