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

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End requirements for local clinical trials when sufficient PK and safety data exists

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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;

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Call on regulatory authorities to expedite and simplify the review of priority paediatric formulations and diagnostics,

GAP-f

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Sub-action ongoing

PEPFAR call on FDA to clarify rules on expedited and simplified development/review process 

PEPFAR

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Paedatric HIV high burden countries to make use of the WHO collaborative procedure to accelerate in country registration of optimal products.

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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.

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Sub-Actions & Milestones

Updates

Notes

Responsible