Key Takeaways
- Joint clinical assessment reports and dossiers submitted by companies under the EU Health Technology Assessment Regulation will be made publicly available.
- While companies can request to have commercially sensitive information redacted, EU authorities will have the final say on what goes into the report.
- This could result in conflict with other strategic business decisions, and the potential impact of information being shared should be considered by manufacturers in advance.
Improving transparency is a key ambition of the EU Health Technology Assessment (HTA) Regulation, but it will also require manufacturers to plan their strategies around sharing confidential information carefully. This...
The HTA Regulation ((EU) 2021/2282) introduced EU-level joint clinical assessments (JCAs) for new oncology products and advanced therapies on 12 January. JCAs will run in parallel...
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