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Swissmedic: eCTD v4.0 Implementation Guide published

Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation package contains a spreadsheet of context, and submission unit types, Swiss eCTD v4.0 Implementation Guide Version 1.0 are now available for download.

The eCTD 4.0 is an upgrade to the previous eCTD 3.2.2 format and includes several new features, including enhanced user guidance and additional regional information, ensuring quality, consistency, and efficiency of regulatory submissions and reviews for human drugs and biologics.

eCTD 4.0 is designed to streamline the process of submitting and reviewing regulatory information by standardizing the format of submissions and facilitating information exchange between regulatory authorities and sponsors.

This technical document describes how the eCTD v4.0 specification can be implemented for Swiss purposes closely following the EU implementation guide. The next step is preparing Swissmedic's technical infrastructure for receiving and reviewing eCTD v4.0 applications.

The technical specifications and implementation guide for the Swiss Module 1 of the Electronic Common Technical Document (eCTD) version 4.0 are outlined in this document, which utilizes the HL7 Version 3 Regulated Product Submission (RPS) Release 2 Normative for human medicinal products.

This document only comprises the Swiss Module 1 part of the eCTD XML message including the Regional Administrative and CH-specific Product Information.

Click this LINK to download the swiss medic's eCTD4.0 Implementation package.


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