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2022 Rome Action Plan on Paediatric HIV & TB



Otsuka commits to:

393. Facilitate access to its child-friendly delamanid formulation in collaboration with the Stop TB Partnership's GDF Paediatric DR-TB Initiative, national TB programmes, and other stakeholders.

394. Finalise technology transfer and continue knowledge sharing that can expediate child-friendly delamanid formulations used to treat DR-TB by generic companies.

395. Initiate and/or support stakeholders and pharmaceutical companies to apply to national drugmregulatory authorities for approval of paediatric formulation of delamanid.

396. Expedite development and regulatory submission of paediatric versions of new TB compounds already in the Otsuka R&D pipeline, with an aim to have paediatric versions available shortly after regulatory approval of the adult formulation.

397. Prioritize the development, registration, and commercialization of priority TB products in research and development plans.

398. Make paediatric formulations and data available to research networks and WHO advancing paediatric PK and safety studies.

399. Timely submit data to regulatory authorities and the WHO to facilitate updating of labelling and recommendations.

400. Use the following best practices for the design and implementation of research studies:

i. Initiate preparation for paediatric studies as soon as a given drug shows promising efficacy and safety in Phase IIb/c adult studies.

ii. Assess acceptability and palatability of formulations, including for use in low-resource settings, at early stages of the formulation’s development.

401. 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.

402. Explore regulatory options to allow access to TB paediatric formulations in other regions and countries currently without access.

403. 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.

404. Provide multilingual Patient Information Leaflets or Instructions for Use to facilitate appropriate use by healthcare workers and caregivers.

405. Register new TB paediatric products timely in countries where registration is required and import waivers cannot be granted for procurement (regardless of source of funding).



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