31 March 2023
Introduction of eCTD v4.0
eCTD v4.0 is a technical standard relating to the submission of applications for the authorisation of medicinal products. The standard – developed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) – is an upgraded version of the currently valid standard eCTD v3.2.2 on which Swissmedic’s current eCTD solution is based. Swissmedic will be implementing the new version gradually.
For more information, see here.
More News
-
-
Swissmedic: New strategic Approach to minimizing Animal Testing in the Development of Medicinal Products
-
Swissmedic: The new Pharmacopoea Helvetica 13
-
European Medicines Agency: New oral GLP-1 Medicine for Weight Management and Type 2 Diabetes
-
FOPH: Capital Income of Health Insurers for Premium Reduction – current voluntary System deemed sufficient
-
Swissmedic: Haemovigilance Annual Report 2025
-
Decision C-6534/2024 of 13 October 2026
-
Swissmedic: GMP Compliance by foreign Manufacturers - Simplifications for Industry and Clarification of unresolved Issues
-
European Medicines Agency: Clinical Trial Applications Advice Pilot becomes permanent
-
Swissmedic: Revision of the Guidance document Authorisation Biosimilar