Action 11
Committed by:
Continue to convene the PAWG to provide advice to innovators prior to submission of PSPs/PIPs, communicate technical opinions to SRAs in a timely manner, and provide dosing and ratio recommendations to generics for development of new FDCs.
World Health Organisation (WHO)
Sub-Actions & Milestones
Sub-action 11.1

Continue to convene the PAWG to provide advice to innovators prior to submission of PSPs/PIPs and communicate technical opinions to SRAs in a timely manner.

WHO

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Sub-action on-going

Milestone 11.2.1

PAWG will communicate dosing and ratio for DTG/ABC/3TC and DTG/XTC/TAF as soon as individual dosing are confirmed

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Milestone 11.1.1

PAWG to review PIPs to provide feedback on alignment with PADO, prioritization and timelines

WHO

WHO/PAWG sent a letter to EMA including considerations for implementation of existing PIPs. Letter includes feedback from PAWG on PIPs for EMA. The messages of the letter will be communicated to relevant companies on dedicated calls with PAWG members to facilitate dialogue. PAWG members will remain available to discuss specific products with relevant innovators.

These considérations were also shared with members of the FDA technical team.

Milestone on-going

PSPs not publicly available for review

Sub-action 11.2

Provide dosing and ratio recommendations to generics for development of new FDCs.

WHO

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Document (s)

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Document (s)

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Updates

Notes

Responsible