EU-level joint clinical assessments (JCAs), which will apply for advanced therapies and oncology products from January 2025 under the HTA Regulation ((EU) 2021/2282), will require companies to answer questions in their dossiers known as PICOs (population, intervention, comparator, outcomes).
EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group
Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.
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Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.
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