The EU Health Technology Assessment (HTA) regulation, which will begin to apply from January 2025, will see companies further utilize historical data to demonstrate the clinical impact of their product, said Christian Schneider, of the pharmaceutical services provider, Cencora, and a former chair of the European Medicines Agency’s Committee for Advanced Therapies (CAT).
Why Historical Data Will Be Important Under The New EU HTA Regulation
The incoming EU Health Technology Assessment Regulation will see historical data move “more center stage” for advanced therapies, because directly comparing highly individualized therapies is often unfeasible, an advanced therapies expert says.
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