With the objective of harmonizing pharmaceutical regulatory practices and legislation with Europe, the Swiss Medicines Agency (Swissmedic) recently conducted an in-depth review of the primary legislation governing the authorisation and lifecycle management of medicinal products in Switzerland. This has resulted in the revision of a number of enacting legal Ordinances, which have revised, or created new, regulatory pathways. These changes were applicable from 1 January 2019 and will be of major interest to both patients and the pharmaceutical industry.
Changes that have been introduced will facilitate market surveillance and thus contribute to the safety of patients. In addition, by aligning procedures with the EU legal framework, it is anticipated that the preparation of documentation for marketing authorisation applications/holders (MAAs/MAHs) will be less onerous, and the subsequent streamlining of processes will avoid duplication of effort. This article summarises these main changes and provides further information on the new content and layout of manufacturing and importation authorisations (MIAs) and wholesale distribution authorisations (WDAs) issued by Swissmedic.