eCTD

The eCTD format is a specific electronic submission format for applications connected with medicinal product authorisations. It optimises the management of medicinal product dossiers and their lifecycle. eCTD is based on the definition of the Common Technical Document (CTD) with its 5 modules and the technical specification V3.2.2 of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). Module 1 is specific to Switzerland, while Modules 2-5 are harmonised internationally.

The following documents regulate and describe eCTD submissions at Swissmedic:

 

  • Swiss M1 Specification for eCTD
  • Swiss eCTD Validation Criteria
  • Guidance for Industry
  • Questions & Answers (Q&A Swiss eCTD Implementation)

When drawing up an authorisation application in eCTD format for a medicinal product that is already authorised abroad, the Guidance Paragraph 13 TPA should be taken into consideration.

The applicant must validate, in advance, the technical correctness of the electronic data in eCTD submissions.

For postal submissions, the results of the technical validation can optionally be documented on the form Technical Validation Part 1. All submitted paper documents required for this purpose must be bound (in loose-leaf binders or ring binders). The prioritisation sheet, which is not part of the eCTD, must be placed on top of the documents.