Swissmedic participation in the European Medicines Agency (EMA) OPEN initiative
28 July 2023 – EMA collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities). The OPEN initiative will enable quicker access to innovative medicinal products for patients. Moreover, it is intended to encourage exchanges between the participating authorities as well as a unified approach to regulatory challenges. It also aims to increase transparency in decision-making. Together with Swissmedic, five other organisations are currently taking part in this initiative.
The first product currently being assessed under the new OPEN framework is an mRNA vaccine against RSV. Moderna has submitted marketing authorisation applications for mRNA-1345 (mRNA-based RSV vaccine) with the European Medicines Agency, Swissmedic in Switzerland and the Therapeutic Goods Administration (TGA) in Australia.
For more information, see here.