Swiss eCTD Module 1 Specification updates – effective October 1st 2015

By 25. September 2015Blog

A revision of the Swiss eCTD Module 1 Specification documentation has been officially published by Swissmedic (link below). The published documentation consists of the following specification documents:

  • Swiss M1 Specification for eCTD v1.3
  • Swiss eCTD Validation Criteria v1.3
  • Questions & Answers of Swissmedic eCTD Implementation v2.0
  • Guidance for Industry on Providing Regulatory Information in eCTD Format v1.7
  • Guidance on applications according to Paragraph 13 TPA for eCTD applications v1.3

Most importantly, the Swiss M1 Specification for eCTD v1.3 was updated with regard to the file structure as well as the file naming sections.
The agency stated that these changes, including the additional changes made to the Swiss eCTD Validation Criteria v1.3 were implemented in preparation of the upcoming Swiss eGov Portal developments. The eGov Portal project is part of the current Swissmedic IT roadmap and includes updates on the way eCTD dossiers are submitted to the agency. The plan suggests that facilitated eCTD upload and sharing on the Swiss eGov Portal will be possible within Q3 and Q4 of 2015 as well as Q1, Q2 and Q3 of 2016.

In addition, the document set includes updates to the general Q&A as well as guidance paragraph 13 TPA documents and will be effective from October 1st 2015 onwards.

The Swiss M1 Specification for eCTD, including the Swiss eCTD Validation Criteria will become mandatory after March 31st of 2016.

Please share your thoughts with us or schedule an expert call with one of our eCTD specialists.

Links:
Swiss M1 Specification documents
Swissmedic IT Roadmap (German) (PDF)

Daniel Koppers

Author Daniel Koppers

Cunesoft CTO, He has more than 7 years experience with software development and project management. Moreover, he has a deep knowledge of life sciences and regulated industries. His previous employers include Nextdocs and Adlib Software. He has a degree in business informatics.

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