Submission Templates for Pharmaceuticals and Medical Devices
The EUnetHTA evidence submission template was developed from an analysis of evidence requirements for reimbursement in Europe. It is a tool that agencies can use to request evidence from companies to support their HTA and reimbursement processes. The tool covers relative effectiveness assessment including a description of the health condition and health technology, as well as clinical effectiveness and safety information. It also includes requests for information about the methodology used to produce the HTA (for example, how studies were identified).
Versions are available for Pharmaceuticals and Medical Devices: