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EMA Updates Pre-Authorization Procedural Advice To Cover Joint Clinical Assessments

 
• By Francesca Bruce

Two new pieces of guidance, from the EMA and the HTA coordination group respectively, should help companies understand which drugs must undergo an EU-wide joint clinical assessment and how to notify the relevant authorities about them.

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New guidance offers developers direction on joint clinical assessments • Source: Shutterstock

The European Medicines Agency has updated its procedural guidance for developers that need to declare that their products will be subject to forthcoming EU-level joint clinical assessments (JCAs), including advice on ensuring that the pre-submission phase for both JCAs and marketing authorization applications (MAAs) can begin at the same time.

Meanwhile, the EU's Member State Coordination Group on Health Technology Assessment (HTACG) has published a guide to help developers identify exactly which products will be subject to a JCA from...

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