All Health Technology Assessment (HTA) articles
-
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 ...
-
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
-
ContentsRegulatory Rapporteur March 2026 – Contents
The March issue of Regulatory Rapporteur focuses on biologicals.
-
EditorialThe innovation era: Where biology meets technology
This issue highlights the rapid evolution of the biologicals landscape and shows why early, transparent regulatory dialogue is now critical to translating scientific breakthroughs into global patient access.
-
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
-
JournalBeyond product approval: Bridging the gap between regulatory success and patient access for biosimilars
This article examines the post-authorisation barriers for biosimilars through the dimensions of affordability, availability and system readiness and gives recommendations to advance access
-
PodcastsRegRapPod − InConversation with Parexel
InConversation talks Joint Clinical Assessment with Sangeeta Budhia and Sinan Sarac
-
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).
-
-
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 ...
-
-
JournalClinical trial design – keeping up with innovation
Regulatory Rapporteur March 2024 | Volume 21 | No.3 Abstract A well-designed clinical trial is essential for the collection of reliable, robust and meaningful data to ensure the protection of participants rights and safety and also minimise economic losses ...