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.
Reestablish the Paediatric Regulatory network to accelerate national registration and facilitate in-country registration of specific products under the Collaborative procedure established by WHO.
In pre-clinical and clinical development, initiate paediatric formulation development as soon as a given drug shows potential public health impact in adults, soon after Phase II trials are completed.
Include adolescents when conducting initial adult efficacy trials, where possible and practical, or conduct parallel trials with the goal of providing information to support licencing for adolescents at the same time as adults.
In the design of paediatric PK and safety studies, use weight-based dosing and enroll all children above 4 weeks concurrently, unless a strong rationale exists for not doing so.
Assess acceptability and palatability of formulations for low-resource settings at early stages of the formulations development.
Engage in early and regular consultations with the PAWG on PIP/PSPs, as well as recommended dosing and ratios for FDC development.
Take all possible measures to rapidly complete development of priority paediatric drugs and formulations in the pipeline, with the goal of providing the maximum number of new formulations by end of 2018, especially for infants and young children.
Undertake studies that use weight-based dosing, enroll all paediatric weight-band groups concurrently irrespective of age, and maximize opportunities to accelerate enrollment of subjects.
Accept and encourage the accelerated steps outlined in Actions 14-18 when evaluating paediatric development plans and reviewing drug applications and encourage formulation development to begin soon after Phase II dosing selection.
Provide funding to support actions required for quickly introducing and scale-up new, optimal paediatric formulations.
Support the early adoption of priority formulations and diagnostics and take steps to facilitate their wider roll-out, including by developing introductory guidance, materials, and other tools for health facilities.
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.
Through UNICEF supply Division, support rapid country adoption of new recommended regimens by including them on the UNICEF procurement services product lists and tenders for long term agreements.
Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Raising awareness in global fora about the unmet diagnostic and treatment needs of children with HIV.
Promote uptake by mobilizing their networks of hospitals and community structures to distribute paediatric medicines in hard to reach places and in situations of conflict and crisis.