Update: Correction of the new eCTD specification documents Swiss M1 Specification and Swiss eCTD Validation Criteria


Due to minor errors in the eCTD M1 Specification and the corresponding eCTD Validation Criteria, both of these documents require correction. For technical reasons, the version number 1.4 will be retained.

In addition, we are providing more detailed explanations here to clarify a number of points.

The following corrections were made to Version 1.4:

  • In the document eCTD Validation Criteria:
    • The folder name 151-infoaccordappIVguidelinebioequivalence is incorrect and should be 151-infoaccordappivguidelinebioequivalence. IV was wrongly capitalised
  • In the document Swiss M1 Specification:
    • The notation of the new elements in Section 1.12, Table 4 is incorrect and will be brought into line with the correct notation in the DTD:
  • 1.8.2 Risk management system. The hyphen was missing in Table 1 and has been reinserted
  •  The hyphen in 1.2.1 is different to that in 1.2.2 in Table 4. The notation of the hyphen has been adjusted

The following corrections have been noted for the future version 1.5 and will be subsequently corrected in that version. The publication date of version 1.5 is yet to be announced.

  • In the document Swiss M1 Specification:
    • In Table 1 under 1.2.2, no fixed component of filename and no life cycle operator are necessary
  •  In line with HMV4, application types pi and eas are no longer necessary and will be deleted from the table.
  • In the document eCTD Validation Criteria:
    • Incorrect entry in the file folder structure and names. There are differences between the M1 Specification and the Validation Criteria. The fixed component of should be foart13.

In response to questions addressed to Swissmedic, our answers are as follows:

Next steps

Both eCTD specification documents are currently being corrected in Version 1.4. These will be published within the next few days and will be available on our website. 

If further errors are discovered which entail additional adjustments, this will be communicated here in good time.