EMA Considers EUA-Style Fast Track Decision For Molnupiravir
Article 5(3) Has Helped Speed Pandemic Response
The European Medicines Agency is considering making a rapid recommendation on MSD’s molnupiravir in order to speed access to the potential ‘game changer’ COVID-19 pill.
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The EU regulator says it is taking the emergency use route for molnupiravir because of the worrying rise in coronavirus infections and deaths.
Bangladesh’s Beximco has launched the world’s first molnupiravir generic, to be marketed as Emorivir, following an emergency use authorization by the local regulator. The company told Generics Bulletin it was able to manufacture and sell its version of the MSD oral COVID-19 treatment thanks to the WTO’s TRIPS waiver for less economically developed countries.
The UK has led the way in granting a marketing authorization for the oral coronavirus treatment, which could help cut hospitalizations and deaths by half.