UAE Adopts Abridged Reviews For Faster Drug Approvals

 
• By Francesca Bruce
  
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The United Arab Emirates has published a new decree setting out procedures for accelerated reviews of innovative and orphan medicines, creating a new standard for the rest of the gulf region.

UAE
UAE Adopts Abridged Reviews

The United Arab Emirates has codified procedures for speeding up the approval of innovative and orphan drugs by conducting abridged reviews that rely on authorizations from one of several key international regulatory agencies. The move is “good for patients and enhances the UAE’s competitiveness in the innovative biopharma sector,” according to Jeffrey Kemprecos, MSD’s executive director of public policy & government affairs in the Gulf region.

Ministerial Decree 28 of 2018 codifies the procedures for innovative and orphan products undergoing abridged regulatory review in the United...

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