implications of increased foreign investment and the impact of product shortages, while positioning us to offer and access reliable products in a growing international market. International considerations Enhance international collaboration and work-sharing The (MMDR) recommended that we better utilise opportunities to work-share with CORs. To facilitate this work we must align our dossier formats. Globally, CORs are transitioning to dossiers. Therefore, to continue and to increase our collaboration, we must also transition. Health Canada, EMA and FDA are well underway with this transition. As an observer on the ICH M8 IWG responsible for the development and implementation of eCTD, we are currently collaborating with other regulators on the development and revision of eCTD specifications, including fixes for the current version 3.2.2 and development of the version 4.0 specifications. To continue to collaborate and comment on this important work our focus needs to be on the eCTD format. Proposed change on the information highlighted above, the TGA proposes to mandate the use of the eCTD format for all prescription medicine dossiers. Applications included in a future eCTD requirement Prescription medicine application types: Category 1 applications via the standard pathway New Chemical Entity New Biological Entity Biosimilar New Combination Extension of Indications Major Variation New Generic Product Variation Changes to PI involving the evaluation of data Extension of Indications Generic Product – Additional Trade Name Category 3 Variation involving only chemistry, quality control and manufacturing – information Minor Variations MEC Changes to PI where no evaluation is required –
implications of increased foreign investment and the impact of product shortages, while positioning us to offer and access reliable products in a growing international market. International considerations Enhance international collaboration and work-sharing The (MMDR) recommended that we better utilise opportunities to work-share with CORs. To facilitate this work we must align our dossier formats. Globally, CORs are transitioning to dossiers. Therefore, to continue and to increase our collaboration, we must also transition. Health Canada, EMA and FDA are well underway with this transition. As an observer on the ICH M8 IWG responsible for the development and implementation of eCTD, we are currently collaborating with other regulators on the development and revision of eCTD specifications, including fixes for the current version 3.2.2 and development of the version 4.0 specifications. To continue to collaborate and comment on this important work our focus needs to be on the eCTD format. Proposed change on the information highlighted above, the TGA proposes to mandate the use of the eCTD format for all prescription medicine dossiers. Applications included in a future eCTD requirement Prescription medicine application types: Category 1 applications via the standard pathway New Chemical Entity New Biological Entity Biosimilar New Combination Extension of Indications Major Variation New Generic Product Variation Changes to PI involving the evaluation of data Extension of Indications – Generic Product Additional Trade Name Category 3 – Variation involving only chemistry, quality control and manufacturing information Minor Variations MEC – Changes to PI where no evaluation is required
consultation-transition-ectd-only-prescription-medicines.docx