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Plans For Mandatory EU Joint Clinical Assessments Watered Down

 
• By Francesca Bruce

Pharma industry representatives are calling for the proposals on health technology assessment cooperation to include more flexibility on uncertainty in evidence supporting orphans and advanced therapies.

Businessman and huge stone . Business problem crisis hardship and burden concept
Council compromise on HTA legislation could add burden for companies • Source: Shutterstock

Drug companies could face duplication of work and added financial and administrative burden if proposals from the Council of the EU are adopted to weaken draft legislation on EU-level mandatory clinical assessments, warns EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs.

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