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.

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

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

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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.

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

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

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

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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.

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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.

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

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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.

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

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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).