NCA (National Competent Authority)
What is it?
An NCA is the country-level regulatory body responsible for medicine safety within its own borders, MHRA in the UK, BfArM in Germany, AEMPS in Spain, and so on. It grants national authorizations, runs local inspections, receives reports directly, and enforces whatever decisions come out of centralized EU review.
PRAC's assessments don't happen in a vacuum above the NCAs, they happen because of them: PRAC's own membership is built from experts nominated by each country's NCA. Centralized EU oversight and national enforcement are two ends of the same system, not competing layers.
Common Misconceptions
"With EMA and PRAC handling safety review at EU level, do individual countries' NCAs still matter much?"
Very much so. National authorization procedures, local inspections, and direct case reporting all still run through the NCA. Centralized review depends on their participation rather than replacing it.
