Navigate the regulation requirements
The European Union’s (EU) new Regulation (EU) on 2021/2282 health technology assessment (HTA) is intended to make innovative health technologies more widely available to EU patients, reduce duplication of efforts by national HTA bodies and ensure resource efficiency. Initial implementation is scheduled to begin in January 2025 for cancer treatments and advanced therapy medicinal products (ATMPs), with full implementation for all therapeutic areas to be finalized in 2030.
The regulation changes represent a monumental shift in the process for bringing medical innovations to the EU market, and these changes will spur the development of a new EU HTA and market access ecosystem over the next few years. As pharmaceutical and technology developers strive to adequately prepare, many questions continue to emerge.