Action 23

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.

Committed by:
The Global Accelerator Partners
Document (s)

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Milestone 23.3.1

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Sub-action 23.3

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

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Sub-action 23.2

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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Milestone 23.2.1

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Sub-action 23.1

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

Milestone 23.1.1

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

PEPFAR

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Milestone 23.1.2

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