Publication of the corrected eCTD specification documents

Swiss M1 Specification and Swiss eCTD Validation Criteria


As announced on 12.12.2018


the corrected eCTD specification documents are now being made available. 

The following corrections have been made: 

  • Swiss M1 Specification

    • The notation of the new elements in Section 1.12, Table 4 is incorrect and have been 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
  • Swiss eCTD Validation Criteria
    • The folder name 151-infoaccordappIVguidelinebioequivalence is incorrect and should be 151-infoaccordappivguidelinebioequivalence. IV was wrongly capitalised. 

Please note that due to technical reasons, the version number 1.4 will be retained. 

The Questions & Answers Swissmedic eCTD Implementation information sheet is also being updated. It includes information and clarification on the use of eCTD in relation to the changes in the M1 Specification.