Swissmedic: eCTD v4.0

The eCTD format is a specific electronic submission format for applications related to drug approvals. It enables optimal management of drug dossiers and their lifecycle. eCTD is based on the definition of the Common Technical Document (CTD) with its five modules and complies with ICH Technical Specification V3.2.2. Module 1 is specific to Switzerland, while Modules 2–5 are internationally harmonized.

The following guidance documents govern and describe the eCTD submission process to Swissmedic:

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

When preparing a marketing authorization application in eCTD format for a medicinal product already authorized abroad, Guidance Paragraph 13 TPA must be followed. The applicant is required to validate the technical correctness of the electronic data in eCTD submissions in advance.

eCTD v4.0 is a technical standard defined by the ICH for electronic marketing authorization submissions. It is a further development of eCTD v3.2.2, on which Swissmedic’s current eCTD solution is also based.

Timeline & Transition

• Technical implementation by the end of 2026
• Production launch in 2027 (following completion of pilot studies)
• eCTD v3.2.2 will continue to be supported during a multi-year transition phase

Swissmedic has also published the Swiss Implementation Guide (Version 1.1). It describes the technical requirements and serves as the basis for software that can be used to create valid submissions for Switzerland. In addition to the Implementation Guide, the documents “Controlled Vocabulary (CV) v1.1” and “Validation Criteria v1.1” are relevant. These files are available for download as a ZIP file on the Swissmedic website.

Next Steps

• Requirements are being continuously refined in parallel with the development of the eCTD review solution; additional versions will follow as needed.
• A final Version 2.0 of the Swiss Implementation Guide is scheduled for early 2027 at the latest.
• Following the completion of the pilot studies, a FAQ document is to be made available in spring of 2027.