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2025 KFDC Spring Conference Review 2 : Pharmacovigilance Part

 

From Concept to Execution: Challenges and Direction in the Integrated RMP Era

 

In June 2025, the Korea Food and Drug Regulatory Science Society (KFDC) held its Spring Conference under the overarching theme of “Regulatory Science Challenges in the Era of AI, Data Convergence, and Advanced Biomedicine.” Among the sessions, “Integrated Risk Management Plan (RMP) Implementation and Future Directions” provided an important forum to discuss the practical implementation of Korea’s newly integrated RMP system, which has been fully in effect since February 2025, as well as strategic directions aligned with global pharmacovigilance trends.

✅ The Integrated RMP System: Where Should It Go From Here?

With the abolition of the previous re-examination system and its consolidation into the Integrated RMP framework, Korea has taken a significant step toward streamlining post-marketing safety requirements. This change is widely viewed as an important regulatory advancement, as it reduces duplicative data submission burdens for the pharmaceutical industry and establishes a more globally aligned post-marketing safety system. However, from an operational perspective, several areas still require refinement. There was a shared understanding that the focus should move beyond structural integration toward improving the actual efficiency and usability of the system in day-to-day pharmacovigilance operations.

Under the legacy re-examination system, additional pharmacovigilance activities were uniformly applied across all products. In contrast, there is now growing consensus that future risk management strategies should be more differentiated, reflecting the individual risk profiles of each medicinal product.

In addition, many Risk Minimisation Measures (RMMs) in practice are still implemented in a relatively formalistic manner. This has led to increasing calls for clearer regulatory guidance on: Expanding allowable RMM strategies (e.g., educational materials, use restrictions, digital tools), Establishing standardized methodologies for evaluating RMM effectiveness, Aligning risk management approaches with real-world product use and clinical environments.

Further improvement areas were also highlighted, including the need to revise legacy terminology such as “use-results surveillance” and “post-marketing surveillance,” extend implementation cycles in a more meaningful way, and clearly define termination criteria to enhance consistency and regulatory clarity.

✅ Leveraging RWD/RWE: The Need for Greater Collaboration Across Stakeholders

Another key topic discussed in the session was the role of Real-World Data (RWD) and Real-World Evidence (RWE) as active pharmacovigilance tools.

Globally, regulatory authorities are increasingly emphasizing the use of RWD/RWE to support science-based decision-making, particularly in evaluating drug safety and effectiveness, as well as assessing the impact of risk minimisation measures.

However, in Korea, several practical challenges remain. Beyond technical limitations in database utilization, there are also administrative barriers such as: Complex procedures for accessing and using databases, Limited flexibility in study design execution, Time constraints in conducting real-world evidence studies.

To address these issues, industry experts emphasized the need for: Cross-sector collaboration linking public and private databases, Establishment of structured communication channels between industry and regulators for RWD/RWE studies, Early-stage scientific dialogue with regulatory authorities to improve feasibility and study design alignment. These measures are seen as essential to bridging the gap between regulatory expectations and operational realities.

✅ Closing Remarks

The KFDC Spring Conference reinforced a shared understanding that Korea’s transition to an integrated RMP system should ultimately lead to a more practical, efficient, and data-driven pharmacovigilance framework.

For successful implementation, continuous collaboration and communication among industry, academia, and regulatory authorities will be critical, alongside ongoing refinement of the regulatory system itself. In parallel, building a robust framework for the use of RWD/RWE will be a key milestone in strengthening evidence-based regulatory decision-making and enhancing the scientific foundation of Korea’s pharmacovigilance ecosystem.

Looking ahead, it is expected that these discussions will gradually translate into regulatory practice, contributing to a more mature and operationally meaningful post-marketing safety environment.