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EU New Active Substance Approvals – A Comparison Of Three Halves

 
• By Ian Schofield

A comparison of EU approvals of medicines containing a new active substance in the first six months of 2021, 2022 and 2023 shows a sharp decline in the 2023 first-half numbers. Three of the products approved by the European Commission in the first six months of this year were for cancer, while two were for infectious diseases (including HIPRA’s COVID-19 vaccine Bimervax). Two products had orphan drug status.

3 empty blue half spheres floating with red and green rim light on bright background.
New EU drug approval numbers have varied over the past three years • Source: Shutterstock

The number of medicines containing a new active substance (NAS) authorized for marketing by the European Commission fell sharply in the first half of 2023, to just 11. This compares with a total of 27 NAS-containing products approved in the first half of 2022, and 28 in the same period of 2021.

The reasons for the decline in EU marketing authorizations up to the end of June are not clear – while the number of approvals does tend to vary from year to year, this

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