ICH Q12 기반 허가 후 변경관리 제도의 국가별 도입·운영 비교:미국·유럽연합·일본·캐나다·대한민국을 중심으로

초록

This study compares the adoption of three key post-approval CMC change management tools defined in ICH Q12—Established Conditions (EC), Post-Approval Change Management Protocol (PACMP), and Product Lifecycle Management (PLCM)—across five regulatory authorities: the United States (FDA), the European Union (EMA), Japan (MHLW/PMDA), Canada (HC), and the Republic of Korea (MFDS). A comparative analysis of laws and guidelines published through January 2026 was conducted, focusing on risk-based change categorization, the regulatory integration of Q12 tools, and the existence of pilot programs. While all five authorities apply riskbased principles, the extent of Q12 tool adoption varies considerably. The United States has institutionalized all three tools through legislation and internal policies. The EU and Japan have substantially advanced PACMP implementation, whereas Canada remains in a phased adoption stage. Korea operates a risk-based, CTD-linked review system but lacks explicit legal or procedural frameworks for any of the three tools. This study proposes a phased adoption strategy through pilot programs and the extension of Korea's pre-submission consultation system to post-approval change management, thereby enhancing regulatory predictability and strengthening the global competitiveness of the Korean pharmaceutical industry.

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