New eCTD specifications documents online

11.09.2015 - As of 11 September 2015, new versions of the following eCTD specifications documents are available online:

  • 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

The Swiss M1 Specification for eCTD and the Swiss eCTD Validation Criteria have been edited, expanded and updated. Both file structure and file naming have been modified. With a view to future eGov portal developments, a number of validation criteria have been adjusted or added.

Parts of the Q&A document have been integrated in the Guidance for Industry or, as the case may be, in the Guidance Paragraph 13 TPA. In addition, the documents have undergone a general revision.

The new versions are valid as of 1 October 2015. For the Swiss M1 Specification and the Swiss eCTD Validation Criteria, a transition period applies until 31 March 2016. During this period, both versions are valid.