EMA’s Frias Defends EU Centralized Switch Procedure Despite Only Delivering Four Reclassifications In 10 Years

Despite delivering only four switches in 10 years, the European Union’s centralized switch procedure was defended by the EMA's Zaide Frias at AESGP's March regulatory conference. Frias pointed to the recent success of HRA Pharma's EllaOne, to the role of pharmacists in driving switches and to the possibility of an OTC Expert Forum as ways forward for the procedure. 

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The EU Centralized Switch Procedure Has Only Delivered Four Switches • Source: Shutterstock

Delivering only four prescription-to-OTC re-classifications in the last decade, the European Union’s (EU’s) centralized switch procedure is viewed by some as a failure.

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‘Nothing Unexpected’ In Third Failed Application For OTC Sildenafil In Germany

 
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.