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Health Canada Updated Specifications for eCTD Validation Criteria V4.4

Since June 2016, Health Canada has been providing the Validation Reports only for regulatory transactions that failed validation. Sponsors are expected to validate their eCTD regulatory transactions and correct any warning(s) and error(s) before sending them to Health Canada. Although…

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SWISSmedic update M1 Specification (v1.4) and eCTD Validation Criteria (v1.4)

On 01 January 2019 the new SWISSmedic update Module 1 Specification for eCTD v1.4 is implemented. Both versions (v1.3 and v1.4) will be valid for a half-year period from 01 January 2019 to 30 June 2019. As from 01 July…

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