Rapid Review

Executive Summary

The NCPE, in collaboration with the HSE Corporate Pharmaceutical Unit (HSE-CPU), consider the cost-effectiveness of all new medicines. In practice, all new medicines are subjected to a preliminary rapid review. The NCPE will endeavour to issue a Rapid Review Assessment report within four weeks of receipt of a rapid review dossier which can be submitted once the company has received recommendation from the EMA CHMP, provided they have certainty around the list price they intend to apply for (this is generally 2-3 months before marketing authorisation (MA) is granted).

This section guides you through the rapid review process, complete with application templates, and outlines what the final outcomes can be, with an analysis of past rapid review outcomes.