Industry news round-up: updates from December 2024
Explore the latest advancements in real-world data (RWD), real-world evidence (RWE) and health technology assessment (HTA) as featured on The Evidence Base during December 2024.
EMA opens public consultation on Data Quality Framework for RWD
The framework aims to provide regulators with a structured approach to assess the quality of RWD, ensuring its appropriateness for generating robust RWE in regulatory assessments.
Key details unveiled ahead of EU HTA Regulation deadline
The newly adopted HTACG Annual Work Programme 2025 outlines the next strategic steps for implementing the EU Health Technology Assessment Regulation (HTAR).
Canada’s Drug Agency launches consultation on health technology assessment methods guide
The agency’s first HTA methods guide aims to enhance transparency, evidence evaluation, and reimbursement decision-making.
US administration advances access to sickle cell disease gene therapies through new funding model
The Biden-Harris Administration's new initiative expands access to FDA-approved sickle cell disease gene therapies, LYFGENIA™ and CASGEVY™, through outcomes-based agreements with manufacturers.
With the imminent implementation of the HTAR, pharmaceutical industry groups have raised serious concerns about the limited availability of joint scientific consultations (JSCs) scheduled for 2025. They warn that this shortage could hinder the rollout of joint clinical assessments (JCAs) and delay patient access to innovative treatments across the European Union.
Raft of new procedural rules and guidance documents published in lead up to EU HTAR
As outlined in the newly adopted HTACG Annual Work Programme 2025, several new guidance documents and procedural rules have been released and are now accessible on the European Commission's platform. These resources provide stakeholders with critical tools to prepare for the full implementation of the EU HTAR.
FDA's new Center for Real-World Evidence Innovation to unlock potential of RWD and RWE
The US Food and Drug Administration (FDA)’s CDER has launched the CDER Center for Real-World Evidence Innovation (CCRI) to enhance regulatory use of RWD and RWE.
BC Platforms, the University of Nottingham and Nottingham University Hospitals NHS Trust are continuing their collaboration to enhance secure data sharing, support research, and improve healthcare outcomes using advanced tools like trusted research environments (TREs).
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