European HTA Legislation Clears Final Hurdle
Risk of unpredictable system still real depending on how EU member states approach joint clinical assessments, warns industry.
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Without further work, the EU-wide joint clinical assessments introduced by the EU regulation on health technology assessments will fail to meet the needs of advanced therapies, warns the Alliance for Regenerative Medicine.
Comparator selection and joint scientific consultation slots are among top concerns for companies operating in the EU as EUnetHTA 21 consortium preparations for new HTA regulations get going.
After years of wrangling, the legislative process for new regulation on greater cooperation on health technology appraisals across the EU has entered its final stages, with parliament expected to adopt the legislation soon.