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‘Pivotal’ Regulation On EU Joint Clinical Assessments Extends Dossier Deadlines

 
• By Francesca Bruce

Despite changes, industry remains concerned over the EU implementing regulation that sets out procedures for joint clinical assessments.

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Five more HTA Reg implementing Acts are to be published this byear • Source: Shutterstock

The newly adopted implementing regulation on EU joint clinical assessments (JCAs) gives developers extra time to prepare their assessment dossiers and introduces an opportunity for them to request a meeting with assessors regarding the scope of the JCAs.

The changes were introduced in line with feedback following a consultation on the draft implementing act, said the commission

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