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EU’s Innovative Drug Approval Tally Shows Sharp Decline

Just 36 Products With New Active Substances Got The All-Clear In 2023

 
• By Ian Schofield

The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.

European flags
The European Commission is responsible for EU drug marketing authorizations • Source: Shutterstock

In 2023, the European Commission approved 36 medicines containing a new active substance, the lowest number since 2019 when just 28 NAS-containing drugs gained an EU-wide marketing authorization.

Among the 36 products were 16 cancer drugs and one gene therapy. Eleven of the approvals were orphan medicines for...

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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
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More from Geography

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 
• By Neena Brizmohun

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 
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