Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
23. Continue to support research networks conducting studies to confirm rifapentine dosing in young children, including children living with HIV.
24. Prioritize the development, registration, and commercialization of priority TB products in research and development plans
25. Engage in early and regular consultations with GAP-f and other WHO-convened expert groups on PIP/PSPs
26. Engage with the Medicines Patent Pool to enter into open, voluntary licensing agreements in preference to exclusive licensing agreements.
27. Facilitate technology transfer and knowledge sharing that can promote faster paediatric formulation development by generic companies.
28. Make pediatric formulations and data available to research networks advancing pediatric PK and safety studies.
29. Rapidly submit data to regulatory authorities and the WHO to facilitate updating of labelling and recommendations.
30. Use the following best practices for the design and implementation of research studies:
Initiate preparation for paediatric studies as soon as a given drug shows promising efficacy and safety in Phase IIa adult studies.
Always include adolescents when conducting initial adult efficacy trials, or conduct parallel trials with the goal of providing information to support licensing for adolescents at the same time as adults.
In the design of paediatric PK and safety studies, study weight-based dosing and enroll all children above 4 weeks of age concurrently (i.e no age de-escalation), unless a strong rationale exists for not doing so.
Assess acceptability and palatability of formulations, including for use in low-resource settings, at early stages of the formulation’s development.
31. Develop drug susceptibility testing (DST) and methods in parallel to new molecule development and make pure drug substance available for DST at the same time as the introduction of a new molecule.
75. Explore regulatory options to allow access to TB paediatric formulations in other regions and countries currently without access (e.g. EU, US, Canada, Australia etc.).
76. Consider the use of the CRP for national registration of paediatric TB products.
77. Ensure all drug registration dossiers meet requirements at the time of filing and that responses to specific queries are complete and provided in a timely manner.
78. Consider facilitating existing joint assessment procedures by planning the submission in different countries/regions to allow for joint assessment in existing networks.
79. Provide multilingual Patient Information Leaflets or Instructions for Use to facilitate appropriate use by Healthcare workers and caregivers
80. Register new TB paediatric products quickly in countries where registration is required and import waivers cannot be granted for procurement (regardless of source of funding)