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

 
• By David Ridley

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.

Having only approved only four switches – GlaxoSmithKline PLC’s Alli (orlistat) weight-loss drug in 2008, Novartis AG’s Pantoloc...

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AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos