Swissmedic participation in the European Medicines Agency (EMA) OPEN initiative

Opening procedures at EMA to non-EU authorities (OPEN) initiative


The EU’s medicines agency, the EMA, is launching an initiative to increase cooperation with international partner authorities. This will enable quicker access to innovative medicinal products for patients. Moreover, the OPEN initiative 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. Swissmedic was already able to acquire initial experience in the pilot phase of the initiative during the COVID-19 pandemic.

The EMA has now extended the scope of OPEN to further medicinal product groups. The initiative henceforth covers medicinal products within the PRIME (Priority Medicines) scheme, as well as other medicinal products for which there is a high level of unmet medical need, medicinal products to treat antimicrobial resistance (antibiotics) and medicinal products used to protect against threats to public health. According to the EU definition, advanced therapy medicinal products (ATMPs) do not fall within the scope of the 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.

This collaboration means that Swissmedic can participate in the meetings of the Committee for Medicinal Products for Human Use (CHMP) and the Emergency Task Force (ETF) as an OPEN partner, with the agreement of the authorisation holders.

Together with Swissmedic, five other organisations are currently taking part in this initiative:

Therapeutic Goods Administration (TGA)


Agência Nacional de Vigilância Sanitária (ANVISA)


Health Canada (HC)


Japan Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)


World Health Organization (WHO)


Ministry of Food and Drug Safety (MFDS) Republic of Korea