The conclusions of a discussion at a recent industry conference in a session on establishing Europe as a center for regulatory excellence were that the discovery of carcinogenic nitrosamine impurities in certain well-established antacid and blood pressure medicine implies that drug companies do not fully understand their products. The conclusions went on to say that incidents such as these should serve as a wake-up call for regulators to review their age-old models for quality evaluation and result in a paradigm shift in how drug impurities are qualified. Pink Sheet forecasts the impact of these statements and shares interpretations of proper risk assessment.