Swissmedic Publishes M1 eCTD Specification, Validation Criteria

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SwissMedic has issued a package of eCTD related specifications

I have only done a cursory analysis as my day job is a bit overwhelming at the moment. The specification differs notably from the EMEA spec in several areas:

  • SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA
  • Module 1 metadata is different, and includes a SwissMedic number and the galenic (dosage) form in both English and other languages, and does not include ATC or procedure type
  • The DTD appears to allow M1 to be repeated per galenic form
  • The concept of regulatory activity, as implemented in related sequence, is present. However, the concept of first and second level activities is not present as it is in EU/US. For example, a sequence of type na-nas can relate to another sequence of type na-nas.
  • The leaf element includes some new attributes such as actuate-list and show-list, and gives a list of values. However, these are not explained or even mentioned in the guidance document.

In other news, EMEA issued their guideline for e-submission for a veterinary medicinal product The guideline specifies the basic parameters required for an acceptable electronic submission, and includes a specification for the folder structure (the granularity) to be used in a basic electronic submission to be known as VNeeS. It does not mention eCTD.

Author: GS

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