In January 2018, the European Commission released a legislative proposal on Health Technology Assessment (HTA) with the overarching goal to strengthen cooperation among national HTA authorities in the European Union (EU).
Under the EU HTA Regulation, manufacturers of health technologies will be obliged to submit a HTA dossier for certain medicinal products for joint clinical assessment (JCA).
After over 3 years of discussion, the final adoption of the policy is drawing near, with the European Parliament and Council reaching a political agreement on the regulation in June 2021.
What is the EU HTA Regulation trying to tackle?
Currently, HTAs are largely conducted at national and regional level by individual EU Member States with different evidence requirements and methodologies employed by HTA authorities.
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