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▶ Background Summary

As of February 2025, major pharmacovigilance (PV) laws and regulations have been amended, shifting the focus of "Post-Marketing Safety Management" entirely toward the Risk Management Plan (RMP). While operational procedures may not change abruptly in the short term, the management of RWD-based proactive surveillance and RMP implementation levels is expected to become the new practical standard for the industry in the mid-to-long term.

▶ Key Legislative & Regulatory Amendments

① Amendment to the Pharmaceutical Affairs Act (Effective Feb 20, 2025)

- The Post-Marketing Safety Management system has been integrated into the Risk Management Plan (RMP) framework.

- The conventional Re-examination System has been officially abolished.

- The industry is expected to move away from traditional PMS (Post-Marketing Surveillance) toward safety evaluations utilizing Real-World Data (RWD) and Real-World Evidence (RWE).

◎ Understanding RWD & RWE ◎

 · RWD (Real-World Data): Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources other than traditional clinical trials.

 · RWE (Real-World Evidence): Clinical evidence regarding the usage, potential benefits, and risks of a drug derived from the analysis of RWD.

 

② Amendment to the Regulation on Safety of Pharmaceuticals, etc. (Effective Feb 21, 2025)

- The scope of RMP submission and its components have been codified at the Prime Ministerial Decree level.

- Requirements previously based on non-binding guidelines (Industry Manuals) have been elevated to statutory standards.

- Submission requirements for clinical trial data and RMPs have been significantly strengthened.

③ Enactment of the Regulation on the Operation of Risk Management Plans (Effective Feb 28, 2025)

- Detailed requirements for RMP implementation duties, data submission/retention, and the role of the Qualified Person for Pharmacovigilance (QPPV).

- By formalizing these as official regulations, the intensity of compliance enforcement is likely to increase.

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▶ Strategic Responses for PV Professionals

Although these changes may not immediately disrupt daily workflows, they signal a fundamental transformation in PV practices. Professionals should prepare in the following areas:

✅ 1. Understanding the RMP-Centric Safety Management System 

The focal point is shifting from PMS-based surveillance to how thoroughly an RMP is designed and executed.

→ Familiarize yourself with the legally mandated submission targets, components, and reporting cycles.

✅ 2. Addressing the Shift from "Guidelines" to "Legal Mandates" Materials previously submitted as 'recommendations' are now 'legal requirements' under the Prime Ministerial Decree.

→ Enhance the precision of documentation and evidentiary support, as the bar for compliance has been raised.

✅ 3. Preparing for RWD-Based Evaluation and Signal Management Post-marketing safety evaluation now demands proactive strategies, including RWD/RWE analysis, going beyond reactive reporting.

→ Establish systems and cross-functional collaborations to collect, analyze, and utilize data effectively beyond existing PMS structures.