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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Teva's Ratiopharm and Italy's Recordati have submitted applications to switch drugs from prescription-to-OTC status through EMA's centralised procedure. Given only four products have been switched centrally to date, a double reclassification would be unprecedented.
The Association of the European Self-Medication Industry (AESGP) warns that many self-care medical devices could fall through the cracks of implementing new EU regulations, as the deadline draws near.
Speakers from the EMA and European Commission, as well as Pfizer and HRA Pharma, debated at the AESGP's Regulatory Conference the ongoing digital transformation of the European consumer healthcare market, the latest developments in the implementation of the new medical devices regulations, and the best ways to encourage Rx-to-OTC switching across the EU.