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Half Of All EU Fast-Track Requests Fail; AZ’s Imfinzi Among Latest

 
• By Maureen Kenny

The European Medicines Agency recently denied AstraZeneca’s pre-filing request for accelerated assessment of Imfinzi in Stage III NSCLC, an indication the company is hoping to make its own. It’ll be no consolation that the EMA this year seems to have rejected as many fast-track requests as it has granted.

Dartboard on wood wall (miss darts)
AstraZeneca is not alone in missing its target of getting speedy EU review • Source: Shutterstock

Companies hoping to fast-track their products in Europe have about a 50/50 chance of getting on the accelerated assessment program at the European Medicines Agency.

In the year to date, the EMA’s Committee for Medicinal Products for Human Use has assessed pre-filing accelerated access requests relating to ten products. Five have been granted and four,...

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EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

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EU CHMP Opinions And MAA Updates

 
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More from Geography

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

UK And US Regulators In Sync On RWD External Control Arms

 
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The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.