의약품 용기포장의 적합성 평가에 대한 국내외 비교 연구 - 용기포장에서 유래한 추출물 및 침출물(E&L) 중심으로 -

Abstract

Extractables and leachables (E&L) from pharmaceutical containers and closure systems can migrate into the drug product, posing a risk to drug product quality and patient safety. This study provides a comparative analysis of the E&L regulatory frameworks in Korea, the United States, Europe, and Japan, highlighting global trends and gaps. The analysis reveals that the United States and Europe have developed detailed guidelines that focus on scientific principles and application by dosage form and route of administration. In contrast, Korea and Japan are in the early stages of developing comprehensive E&L regulations, with Korea developing E&L assessment guidelines in the Korean Pharmacopoeia’s General information. Based on the effort of the Ministry of Food and Drug Safety (MFDS) of South Korea to strengthen its international status and lead global standards, such as listing WLA and promoting joining PDG, strengthening E&L assessment regulations is important to ensure patient safety, reduce regulatory and industry burden, and enhance Korea’s competitiveness in the global pharmaceutical market. This study highlights the importance of regulatory convergence and the development of harmonized E&L assessment criteria, particularly through ICH Q3E. By promoting collaboration between regulators and the pharmaceutical industry, Korea can position itself as a leader in global pharmaceutical regulation and innovation.