Swissmedic joins an initiative by the EU Medicines Agency to strengthen international cooperation. It is about faster and more transparent approval of innovative medicines. Swissmedic already gained experience with this during the Covid 19 pandemic.
The European Medicines Agency (EMA) extended the initiative to other drug groups, as Swissmedic announced on Wednesday. The enhanced international cooperation now extends to medicines for unmet needs, antibiotics and medicines to counter threats to public health.
According to the EU definition, advanced therapy medicinal products were not covered by the cooperation. The first drug to be evaluated under the new collaboration is an mRNA vaccine against respiratory syncytial virus.
This causes most cases of bronchitis in infants and young children. RSV causes annual epidemics in the cold season. In Switzerland, these are stronger every two years.
Pharmaceutical company Moderna has submitted an application for approval of its RSV vaccine to the EMA, Swissmedic and the Australian Therapeutic Goods Administration.
In addition to the Australian and Swiss regulatory authorities, the Brazilian, Canadian and Japanese medicines authorities and the World Health Organization are also members of the EMA initiative.
(jam/sda)
source: watson
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