Swissmedic accepts purely electronic submissions in eCTD format only, in accordance with the current version of the ICH eCTD specification.
In terms of content, the ICH eCTD specification is based on the definitions used for the Common Technical Document (CTD) and consists of its 5 modules. Module 1 includes country- and region-specific information and is defined by the competent authorities. Modules 2-5 are standardised internationally.
The following documents regulate and describe eCTD submissions at Swissmedic:
- The document Swiss M1 Specification for eCTD describes the requirements for drawing up a compliant, Swiss-specific Module 1.
- The document Swiss eCTD Validation Criteria describes the criteria for the technical conformity assessment and is closely aligned with the European regulations (EMA).
- The document Guidance for Industry serves as a practical overall guideline for submission.
- 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 document Questions and Swissmedic's answers (Q&ASwiss eCTD Implementation) contains questions relating to the submission that have not (yet) been included in the above-mentioned regulatory documents.
The applicant must validate, in advance, the technical correctness of the electronic data in eCTD submissions. To do so, various free validation tools are available (see Useful links).
Please note that using a validation tool does not replace Swissmedic's internal controls regarding technical correctness. Swissmedic assumes no responsibility for the compatibility of the validation tool used with the current version of the Swiss eCTD Validation Criteria.
It is at the discretion of the applicant to comment the results of the test on the form Technical validation eCTD, Part 1. The form is available in three languages (d, f, e).
Submission of paper documents with eCTD applications
All paper documents must be bound (in loose-leaf binders or ring binders). The individual documents may be stapled together but may not be placed in transparent folders.
Each set of documents submitted must contain a prioritisation sheet at the top of the pile containing information on the submission format and type. The prioritisation cover sheet is not an integral part of the eCTD.