Pharma companies must comply with pharmacopeia regulations, like the USP for the US and Ph.Eur. for Europe, to market drugs. The USP has long had a chapter on lab balances, while the Ph.Eur. introduced a similar mandatory chapter in January 2022. Our infographic compares lab balance rules in both pharmacopeias, noting their differences.
The FDA opened an expedited IND pilot, tightened scrutiny of foreign trial data, and finalized a rule recognizing non-animal testing methods. In Europe, the EMA advanced pharmaceutical legislation reform, restricted 2 legacy products, and opened an injectable-iron safety review.
Ron Scarboro, Azurity Pharmaceuticals, explains why real-world usability belongs at product definition and how post-launch feedback should guide drug formulation.
Gene manufacturing platforms, patient-centric formulations, contract services, packaging innovations, and sterile filling lines are in the spotlight at CPHI Milan 2026.