2026 CONVENTION
Analysis of changes in korean GMP regulations and pharmaceutical industry responses: ten years post-PIC/S accession
Pharmaceutical manufacturers must comply with Good Manufacturing Practice (GMP) to ensure drug safety, efficacy and consistent quality. Korean GMP, introduced in 1977 and mandated in 1994, has been strengthened since the Ministry of Food and Drug Safety (MFDS) joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014. The MFDS passed the PIC/S reassessment to retain membership in 2024. However, little research has examined how industry has responded to these changes. This study compared Korean GMP with PIC/S GMP through a literature review and surveyed 50 employees with QA, QC, production and RA experience. Overall, 72% perceived the tightening as substantial and 64% supported its continuation, indicating broad acceptance. Ambiguity in guideline interpretation (62%) was the greatest barrier, and demand was highest (72%) for specific inspection guidelines, guidebooks and violation casebooks. The three-year re-evaluation burden was cited only by small firms (26%). By role, RA stressed licensing burden, QA/QC quality-system improvement and production on-site compliance. Although the small sample (N=50) limits the analysis to descriptive trends, these findings suggest that the industry accepts stronger GMP but needs clearer guidance and support tailored to company size and job function. This study provides baseline data for GMP policy and industry support.