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.
Develop a toolkit to set standards and support accelerated research, development, and introduction of priority paediatric formulations.
Work with countries on creating demand for paediatric HIV treatment services including generation of age disaggregated data to inform the better planning and supply forecasting.