EMA Reviewing Two Centralised Switch Applications
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.
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Italy's Recordati enjoyed strong growth in its home market and abroad, lifting OTC group sales in 2019.
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.
Global supply of paracetamol could soon improve after India said it would allow some exports of the drug. The country introduced severe export restrictions in March to ensure it had a sufficient stockpile of paracetamol to meet internal demand during the COVID-19 outbreak.