12. Discourage and refrain from funding national evaluation studies that would be duplicative of studies done for WHO PQ listing or SRA approval.

13. Fund impactful technologies and interventions quickly.

14. Support in a transparent manner the procurement of commodities and operational costs to maintain and further scale-up POC EID, as well as viral load testing for infants, children, and pregnant and breastfeeding women, as an integral part of optimized and integrated national laboratory networks and in accordance with national EID and VL plans and targets.

15. Support the development of a competitive, healthy, and sustainable market for POC and laboratory technologies.

16. Continue to support WHO PQ to shorten timelines for dossier review and minimize time to national registration.

-

16. Support the development of a competitive, healthy, and sustainable market for point-of-care and laboratory-based testing for TB infection and disease as well as digital x-ray technologies.

 

17. Consider increasing investments in diagnostic research and development, case-finding, and scale-up of product procurement in high TB burden countries.

 

18. Support country level roll-out of new tools for pediatric TB detection, including testing of nasopharyngeal aspirates, stool, urine, and other non-sputum specimens.

 

19. Consider support to build evidence base for product development, evaluation, and WHO guidance.

 

20. Add paediatric-specific diagnostics and associated specimen collection devices/consumables to available diagnostics catalogues.

 

21. Include TB-LAM and other urine-based lateral flow assays in procurement considerations in all countries but especially for high HIV burden countries.

 

22. Support the development of pediatric X-ray libraries to facilitate the development of machine learning algorithms for the interpretation of pediatric chest X-rays.

 

23. Support more coordinated diagnostic network strengthening and optimization exercises, led by national governments, across diseases (TB and HIV as well as other key diagnostics).

 

24. Support the development of biomarker-based tests for infants and children, as well as tests and/or testing procedures that use alternative (non-sputum-based) specimens.

 

25. Facilitate appropriate budgeting and access to quality-assured TB diagnostics at affordable prices and ensure a sustainable market and supplier accountability.

45. Support countries’ TB case finding strategies that address children and country-level uptake and scaling up of new tools for TB diagnosis in children, as per international guidance.

46. Support more coordinated diagnostic network strengthening and optimization exercises, led by national governments, across diseases (TB and HIV as well as other key diagnostics).

-

54. Support GAP-f partners’ plan for the accelerated introduction and rollout of the DTG 10mg dispersible tablet formulation in priority countries to ensure early and wide uptake.

55. Support stakeholders involved in accelerated introduction and rollout of the 4-in-1 formulation as an alternative regimen for young children.

-

21. Support catalytic procurement of all or part of initial validation batches from manufacturers such that product availability is not delayed once approval or tentative approval is achieved.

22. Incentivize commercialization of new pediatric ARV products “at risk” to accelerate introduction and scale up of new paediatric ARV product such that product is available at time of approval/tentative approval/prequalification.

-

22. Support, strengthen, and expand clinical and implementation research to inform development, approval and use of paediatric formulations included in the priority list, including early PK modelling and palatability studies.

102. When negotiating grants, encourage countries to address health product management and domestic procurement challenges that may negatively affect the procurement of quality, affordable health products, including the procurement of small volume or small market products, such as pediatric DS and DRTB drugs.

103. Continue to use a flexible approach in the implementation of the co-financing policy, particularly related to small volume, small market products that might be more challenging to procure effectively via domestic procurement.

 

104. With partners, support and encourage countries to adequately prepare to procure small volume, small market products as they increase their role in domestic procurement and encourage the use of international pooled procurement platforms. In alignment with recommendations from the United Nations High Level Meeting on Tuberculosis in 2018, encourage the use of STBP/GDF when countries are unable to efficiently procure such products directly from suppliers.

-