Swiss eCTD: Updating of Module 1 as of January 2019

Updating of the eCTD Module 1 (M1) specifications owing to the revision of the Therapeutic Products Ordinances.

Implementation of the revised Therapeutic Products Ordinances requires adjustments to the data and systems used by Swissmedic for categorising variation applications.

Swissmedic will publish the amended M1 specification on 1 November 2018. Subsequently, companies and software suppliers will have eight months in which to implement these changes and adapt their systems.

Amendment of specification deadlines

With regard to eCTD applications submitted between 1 January 2019 and 30 June 2019 (end of transitional period), Swissmedic will issue rules on how these can also be submitted under the current version of the eCTD M1 specifications and in accordance with the new legislation.

The rules (eCTD Guidance for Industry and eDok Guidance) will be published on 30 September 2018.