European Medicines Agency (EMA)

Rule Changes

Preparing to implement streamlined structures and faster review processes under the new pharma package

After two years of trench warfare between EU governments, lawmakers and drug makers, Brussels has finally agreed a 'pharma package' that tears up the bloc's 20‑year‑old drug rules. The package locks in eight years of data protection, one year of market exclusivity, and bonuses extending to 11 years if companies meet public‑health goals.

Updated 5 days ago