All Joint Clinical Assessment (JCA) articles
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Industry newsEuropean Commission publishes first joint clinical assessment under EU HTA regulation
The European Commission released the first joint clinical assessment (JCA) report on 9 June for the orphan medicine tovorafenib (Ojemda®), developed by Ipsen, used to treat paediatric low-grade glioma (a type of brain tumour), after being endorsed by all member states. This marks an important milestone for European ...
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JournalRegulatory affairs as a strategic function in market access of medicinal products: Pre‑COVID-19 context, COVID-19 acceleration and post‑COVID-19 convergence across 11 markets
This article looks at how regulator, HTA body and payer interfaces have evolved since the COVID-19 pandemic and how regulatory affairs has become a strategic integrator of regulation, evidence and access
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JournalThe EU’s Health Technology Assessment Regulation: Implementation one year on
This article looks at the impact of EU-HTAR on national HTA bodies, developers and patients so far, and discusses what comes next
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PodcastsRegRapPod − InConversation with Parexel
InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
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JournalHM7: First experiences with the HTA Regulation
This is a report of the HM7 session that took place at this year’s Symposium.
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JournalThe EU’s Health Technology Assessment Regulation: Overview and considerations for regulatory teams
The EU’s Health Technology Assessment Regulation (EU-HTAR) demonstrates a significant transformation in how health technologies are evaluated across EU member states (MS). The regulation, which came into effect on 12 January 2025, establishes a partnership between the European Medicines Agency (EMA) and national Health Technology Assessment (HTA) bodies through introducing joint clinical assessments (JCAs) and joint scientific consultations (JSCs).
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JournalA key role for the European Medicines Agency in the European Union’s Health Technology Assessment Regulation
Regulatory Rapporteur June 2024 | Volume 21 | No.6 Abstract The need for early collaboration between regulators and European Union’s (EU) Health Technology Assessment (HTA) bodies when developing ‘fit-for-purpose’ evidence generation plans has long been acknowledged, and the ...