Key Takeaways
- Companies will need to leverage historical data to compare their products to other existing therapies as part of EU-level joint clinical assessments under the new HTA regulation.
- Conducting direct clinical trials comparing advanced therapies can be unfeasible due to the highly personalized nature of these products, says advanced therapy expert Christian Schneider.
- Smaller companies are particularly vulnerable to these challenges and Schneider advises them to speak to regulators early.
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...
The new regulation, which will begin to apply for new advanced therapy medicinal products (ATMPs) and oncology products from 12 January and for other products by 2030, is a “really...