Drug Approvals
What Is Drug Approval? How FDA and EMA Decide
How drug approval works: what regulators assess, how FDA and EMA review differ, expedited pathways, conditional approvals, and what happens after authorisation.
Pharmacovigilance
A trial of a few thousand people cannot detect an adverse effect that occurs once in fifty thousand. Pharmacovigilance is the monitoring that continues after approval, when a medicine meets the far larger and less selected population that will actually take it.
Our reporting covers how signals are detected and investigated, how quickly regulators act on them, and what a safety review means for people already taking a medicine.
Drug Regulation
EMA Explained: How Europe Regulates Medicines
What the European Medicines Agency does: the centralised procedure, CHMP and PRAC, marketing authorisation, pharmacovigilance, and how EMA differs from the FDA.