With the increase in the drug counterfeiting across the world, many countries along with the Global Standards body (GS1) have come up with various country regulations which can keep counterfeiting at bay. With Serialization and new traceability requirements in many countries, the life sciences industry is undergoing a paradigm shift in the way it labels and transacts sales of prescription drugs and biologic products.
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.