After nearly a decade of policy development and negotiation — a timeline that makes a typical Phase III trial look brisk — the EU’s pharma reform package has officially crossed into “final draft” territory. The European Council and the European Parliament finalized the text in March, with formal adoption expected by the end of this year and most rules biting around 2028.
5 min read
Regulatory
Watchdog Wednesday: The EU’s Modular Exclusivity Era Has Arrived
The EU pharma reform package has a 2028 implementation date. That is not a reason to wait.
