Element card for assessment element A0020 in HTA Core Model Application for Pharmaceuticals (2.0) application

A. Health Problem and Current Use of the Technology

Regulatory Status

What is the marketing authorisation status of the technology?


There are both international and national market authorisation systems. An overview of the status with regard to key processes, e.g. CE marking, EMA/FDA approval is recommended. Also information on national data and an analysis of possible discrepancies can be highly useful.

CE-Approval, EMA, FDA, national authorities. Manufacturers should be contacted in order to identify which steps have they taken/ are they planning to take concerning market approval




Burls 2000 {1}, Busse 2002 {2}, Liberati 1997 {3}, Imaz-Iglesia 1999, Kristensen 2007 {24}