HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
Call on regulatory authorities to expedite and simplify the review of priority paediatric formulations and diagnostics, including by:
-
Making better use of sub-regional collaborative regulatory approval processes and the WHO Collaborative procedure for accelerated registration;
-
Increasing reliance on evaluations and opinions of stringent regulatory authorities (SRAs) and the WHO prequalification program, up to providing full waivers for high priority paediatric drugs;
-
Allowing compassionate use until drugs are registered; and
-
Ending requirements for local clinical trials when sufficient PK and safety data exists, even when no innovator equivalent exists.
The Global Accelerator Partners
-
-
-
-
-
-
-
-
End requirements for local clinical trials when sufficient PK and safety data exists
-
-
-
Increase reliance on evaluations and opinions of stringent regulatory authorities (SRAs) and the WHO prequalification program, up to providing full waivers for high priority paediatric drugs;
-
-
-
-
-
-
-
Call on regulatory authorities to expedite and simplify the review of priority paediatric formulations and diagnostics,
GAP-f
-
Sub-action ongoing
PEPFAR call on FDA to clarify rules on expedited and simplified development/review process
PEPFAR
-
-
Paedatric HIV high burden countries to make use of the WHO collaborative procedure to accelerate in country registration of optimal products.
-
PEPFAR and WHO PQ have discussed how to implement CRP based on SRA approval, conversation ongoing. Countries among the AIDS FREE priority countries who are not included in CRP list were identified.
-
Sub-Actions & Milestones
Updates
Notes
Responsible