U.K. expands scope of abbreviated review pathway

The MHRA is expanding its abbreviated regulatory pathway for drugs approved in the EU to include more international regulatory agencies, with the twin goals of easing the burden on its short-handed staff and maintaining the U.K.’s position as a first-tier drug launch destination. 

A remnant of the Brexit transition phase that allowed companies with drugs approved in the EU to submit the same dossier for an abbreviated approval in the U.K. is being expanded to include the U.S., Japan, and the four other countries that are part of the Access Consortium: Australia, Canada, Singapore and Switzerland...