CAT gives opinion on experimental data for first SME
This article was originally published in Clinica
Executive Summary
The European Medicines Agency’s Committee for Advanced Therapies (CAT) has adopted its first opinion on the certification of experimental data generated for an advanced therapies medicinal product (ATMP) under development by a small or medium-sized enterprise (SME).
You may also be interested in...
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.