39. Ensuring global access to its child-friendly delamanid formulation in collaboration with the Stop TB Partnership's GDF Pediatric DR-TB Initiative, national TB programmes, and other stakeholders.
40. Performing technology transfer for child-friendly delamanid formulations used to treat DR-TB, to be completed shortly after first stringent regulatory authority approval of the formulation.
41. Expedite development and regulatory submission of pediatric versions of new TB compounds already in the Otsuka R&D pipeline, with an aim to have pediatric versions available shortly after regulatory approval of the adult formulation.
42. Prioritize the development, registration, and commercialization of priority TB products in research and development plans.
43. Facilitate technology transfer and knowledge sharing that can promote faster paediatric formulation development by generic companies.
44. Make pediatric formulations and data available to research networks advancing pediatric PK and safety studies.
45. Rapidly submit data to regulatory authorities and the WHO to facilitate updating of labelling and recommendations.
46. 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.
Assess acceptability and palatability of formulations, including for use in low-resource settings, at early stages of the formulation’s development.
47. 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.
81. 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.).
82. Consider the use of the CRP for national registration of paediatric TB products.
83. 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.
84. Consider facilitating existing joint assessment procedures by planning the submission in different countries/regions to allow for joint assessment in existing networks.
85. Provide multilingual Patient Information Leaflets or Instructions for Use to facilitate appropriate use by Healthcare workers and caregivers
86. 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)
Regulatory submission to the relevant competent authority is made for obtaining regulatory approval in 2021 for the child-friendly Delamanid dispersible tablet. Simultaneously, Otsuka has entered into a collaboration for technology transfer of Delamanid’s dispersible formulation. The dispersible formulation technology transfer is an important step towards honouring Otsuka’s commitments for ensuring affordable access to Delamanid for children suffering from DR-TB.