The European Pharmacopoeia's new Chapter 2.1.7 on analytical balances was published on July 1, 2021, and became mandatory for pharma companies in Europe from January 1, 2022. It outlines calibration and performance standards for balances. Our white paper compares this with USP Chapters <41> and <1251>.
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.