Global Dossiers in the Joint Clinical Assessment Era: Impacts and Implications

Joint clinical assessment (JCA) is a European Union (EU) initiative intended to improve patient access to health technologies in Europe through a harmonized clinical health technology assessment (HTA) process. From January 2025, all new oncology medicines and advanced therapy medicinal products will go through the JCA process, followed by all orphan medicinal products from 2028 and all new medicines from 2030.

The JCA process will run parallel to European Medicines Agency (EMA) regulatory evaluation and will involve submission of a dossier detailing disease information, product information and clinical data, but will not include economic data, which will be assessed later, at national level.

As JCA comes into effect, manufacturers will need to carefully consider their processes for development of global value/reimbursement dossiers to ensure that they continue to meet the needs of their affiliates in Europe and beyond.

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