The Life Science industry and regulatory profession have a plethora of acronyms and technical terms. Our glossary aims to help make sense of these. Search by clicking on the letters above.
Latest definitions
Early Dialogues Working Party (EDWP)
The Early Dialogues Working Party (EDWP) is a standing committee established by EUnetHTA to ensure robust high-quality HTA outputs. All…
De Novo
The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices without a predicate as class…
Cost-Effectiveness
Cost-effectiveness is the ratio of the cost of a therapeutic or preventive intervention to a relevant measure of its effect.…
Core Value Dossier
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national…
Core Reimbursement Dossier
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered…
Consolidated Parallel Consultation
Products selected for this pathway will have an EDC composed of the EDWP members and up to 3 additional HTABs.…
Conditional Marketing Autorisation
The approval of a medicine that address unmet medical needs of patients on the basis of less comprehensive data than…
Competent Authority
Is responsible for the authorization of medicines / medical devices and for ensuring that medicines and medical devices work and…