Module 1 2021

25/06/2021

Electronic submissions: Region by region – Japan (1)

• Marketing Applications ─ As ICH members, the PMDA have been adopters of the eCTD, though at a slower pace than US and EU ─ The eCTD is not adopted for all submission types ─ The eCTD lifecycle is not implemented in the same way ─ However, the eCTD is moving from an “archive” format to a standard “submission” format without paper

The Organisation for Professionals in Regulatory Affairs

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Electronic submissions: Region by region – Other Regions (1)

• Canada • Health Canada have been members of the ICH eCTD Expert Working Group since the start • eCTDs have been acceptable since 2009 for Marketing Applications (NDS) • Not acceptable for clinical trial submissions • Switzerland • Also founder members of the ICH eCTD EWG • SwissMedic will only accept the eCTD (there is no equivalent to the NeeS) • However, the Swiss guidance follows the EU in many places and allow for the easy creation of the initial MAA submission

The Organisation for Professionals in Regulatory Affairs

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