Voisin Consulting Life Sciences glossary icon

Competent Authority

Click a letter to view all its definitions

Is responsible for the authorization of medicines / medical devices and for ensuring that medicines and medical devices work and are acceptably safe.

Its role is to authorize, monitor, control, inspect and inform.

Other glossary definitions


Periodic Summary Reporting

Alternative reporting regime that is agreed between the manufacturer and the National Competent Authority for…

View definition

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU…

View definition