eCTD submission Regulatory

Swissmedic updated eCTD specification and validation criteria to version 1.5

Switzerland’s regulatory authority Swissmedic updated guidance on submitting regulatory information in eCTD format to the Swiss Agency for Therapeutic Products.

Swiss medic updated the eCTD M1 specification, DTD along with validation criteria to version 1.5 on 1st April 2020.

Below are some highlights for change in version 1.4 to 1.5 in M1 eCTD specification.

  • Notation Let abis quater harmonised throughout (tables 1 and 4)
  • Operator modified under
  • Notation na-co-marketing corrected
  • List of application types modified in Appendix 2 and 4
  • Fixed component modified under 1.2.2 in table 1
  • Life Cycle Operator modified under and in table 1
  • Notation paragraph13 changed to article 13
  • Section 1.2.2 ann form changed to form-add
  • Section 1.12.2 deleted in table 1
  • Comments in table 4 revised, no technical changes
  • Directory 1.5.1 in table 4 corrected to 151-infoaccordappivguidelinebioequivalence
  • Section 1.5.4 added
  • Example for use of CC in Appendix 1 modified
  • Editorial corrections

Swissmedic also said that “Transition period for the published documents are valid as of 1 April 2020. A 6-month transition period in which DTD v1.4 and DTD v1.5 can be submitted will apply until 30.09.2020. After 01.10.2020, only eCTD submissions according to DTD v1.5 will be accepted.”

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