Tag: SwissMedic

ACUTA, ARIM, eCTD, Switzerland

SwissMedic Updated eCTD Guidance November 2018

On November 1, SwissMedic, the regulatory agency for Switzerland, updated their guidance for eCTD, including a new version 1.4 of the Data Type Definition (DTD), and validation rules. This corresponds to the recent Revision 4 of the Therapeutic Product Ordinances (HMV4). These rules area available starting January 1, to become mandatory in June. If you …