What it means to receive a positive EMA qualification opinion for the PREFER framework

The PREFER project developed a framework with points to consider for methods selection. We asked the European Medicines Agency (EMA) and EUnetHTA to assess this document and issue a public qualification opinion on how useful the PREFER approach is from the regulatory and HTA perspective. In April 2022, the EMA committee responsible for human medicines, CHMP, issued a positive qualification opinion. We are now sharing lessons learned from the process and some of implications for the future. 

The PREFER framework can be used by industry, regulators and health technology assessment bodies who want to know how to use patient preferences as input in medical product decision making. In June 2022, PREFER organised a webinar where we explain the key findings from the process and potential future implications. Want to know more about the process? The recording is now available.


In their discussion for a positive opinion, the CHMP stated that the framework is comprehensive and enables planning and conducting patient preference studies.  The framework "may furthermore support interactions between industry, regulators (and HTA bodies/payers, as well as patients….[Additionally], the points to consider chapter can support designing future PPS to generate evidence on patients’ views with the goal of informing decision-making."  The CHMP stress the importance of seeking regulatory scientific advice if such preference studies are being considered by sponsors to support a medical product's approval.

Want to know more? Watch the recorded presentation. You can also download slides from this presentation, read the qualification opinion from the CHMP, or have a look at the PREFER recommendations, where the framework is included.  

By Josepine Fernow





  • Disclaimer: This website and its contents reflects the PREFER project's view and not the view of IMI, the European Union or EFPIA.


The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).