Home> Multi-stakeholder Projects> Qualification of novel methodologies - “Proof-of-Principle” study

Qualification of novel methodologies - “Proof-of-Principle” study

HARMONY, Multi-stakeholder


The European Medicines Agency (EMA) has an existing pathway that provides EMA opinions on the validity of new methods relating to the generation or synthesis of evidence submitted for regulatory assessment, called “Qualification of Novel Methodologies.” 

A joint parallel procedure, “Regulatory -HTA/Payer Qualification of Novel Methodologies”, could be conducted in the context of HARMONY. There is currently no equivalent of this process for payers and HTAs in different countries.

Project Partnership

Project Leadership


Project Summary

HARMONY will explore how “qualification of new methodologies” can be run operationally and whether it can deliver meaningful outcomes for three types of decision-makers: payers, regulators and HTA agencies. It will also be considered whether this approach is viable in the future, evaluating resources and costs of participation. 

A pilot, joint qualification procedure could include deliverables from:

The final selection of a deliverable to undergo this proof of principle approach will need to be agreed upon and further defined by the consortium.