earticle

영어

Drugs are directly related to disease treatment and differ from general consumer goods. Biological products, which are high-cost and high-risk, are highly sensitive to temperature fluctuations; exceeding recommended storage conditions can compromise both efficacy and safety. The International Council for Harmonisation (ICH) provides stability test guidelines that define scientifically justified storage conditions and expiration criteria to ensure drug quality, safety, and effectiveness. Based on these guidelines, national regulatory authorities establish their own standards for drug storage and distribution. However, temperature excursions still occur during distribution, and especially at the patient storage stage. Self-Injectable Drugs which have increased in use, have system limitations. Patients themselves are directly responsible for storage and administration at home, so they cannot check the state of a drug’s condition. Studies have shown that patients frequently fail to maintain proper conditions. To address these challenges, this study aims to develop a regulatory science-based temperature monitoring system. The Time-Temperature Indicator, a color-changing label that irreversibly reacts when exposed to excessive temperature, is proposed as a simple, user-friendly and cost-effective solution. By analyzing domestic and international temperature monitoring regulations and identifying blind spots in current cold chain systems, this study seeks to enhance patient safety, strengthen public trust, and minimize economic losses.