Quote from VigiServe Admin on November 27, 2020, 2:18 PM

The pharmacovigilance (PV) system in **South Korea** is highly developed, mature, and fully aligned with international standards (ICH, WHO, and EU GVP principles), managed by the **Ministry of Food and Drug Safety (MFDS)** through its **National Institute of Food and Drug Safety Evaluation (NIFDS)** and the **Korea Institute of Drug Safety and Risk Management (KIDS)**. KIDS operates the national PV center (KAERS – Korean Adverse Event Reporting System) for ADR/AEFI collection, signal detection, causality assessment, risk evaluation, alerts, recalls, and VigiBase contributions (full WHO PIDM member since 1998). The system includes mandatory post-marketing surveillance (PMS) and is enforced under the **Pharmaceutical Affairs Act** and related MFDS regulations (e.g., **Regulation on Safety of Pharmaceuticals**).

**Legal Framework and Governance**
- Primary regulations: Pharmaceutical Affairs Act, Regulation on Safety of Pharmaceuticals (MFDS ordinances), and specific PMS/PV guidelines.
- MFDS/KIDS handles national coordination, risk management, inspections, and safety communication.
- Recent focus (2025–2026): Faster drug approvals (reduced timelines via dedicated teams/rolling reviews), enhanced PMS, and continued E2B(R3) electronic reporting.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs) must establish and maintain a robust PV system.
- **Local Authorized Representative / Responsible Person**: Foreign MAHs must appoint a **local representative** in Korea (often a Korean entity or agent) responsible for regulatory liaison and PV compliance (mandatory for import/registration).
- **Qualified Person for Pharmacovigilance (QPPV)** or local equivalent: Not strictly mandatory as a named resident QPPV (unlike EU), but MAHs must designate responsible personnel for safety monitoring/reporting.
- **Pharmacovigilance System Master File (PSMF)**: Required (detailed content per guidelines); maintained and available for MFDS inspections (no mandatory registration/location, but accessibility enforced).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs must collect/report all suspected ADRs (serious/non-serious), medication errors, lack of efficacy, and quality defects to KIDS via KAERS (electronic E2B(R3) mandatory).
- **Timelines** (ICH-aligned):
- **Serious ICSRs** (unexpected or increased frequency/severity): Expedited within **15 calendar days** of receipt.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Foreign ICSRs: Included in periodic reports if relevant to benefit-risk.
- Minimum valid report criteria: AE information, drug information, patient/reporter details.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit PSURs/PBRERs (ICH E2C(R2) format) to MFDS.
- Frequency: Typically every **6 months** initially (post-approval), then annually or as specified (during renewals/variations/safety concerns).

**Risk Management Plans (RMP)**
- Mandatory for high-risk products, new drugs, biologics, orphan drugs, or specific concerns (per regulations).
- EU-style format with Korea-specific adaptations/annex.
- Updates required for new risks or significant changes; MAHs conduct risk management per submitted RMP.

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor global/local data and notify MFDS/KIDS of validated signals or emerging concerns promptly.
- MFDS/KIDS performs national signal detection (using VigiLyze/tools) and risk assessment.

**Clinical Trials-Related Safety Requirements**
Clinical trials require MFDS approval (Investigational New Drug [IND] application; aligned with ICH GCP).
- Sponsors monitor safety and report to MFDS.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (ICH E2A-aligned):
- Fatal/life-threatening SUSARs: **7 calendar days**.
- Other serious unexpected SUSARs: **15 calendar days**.
- **Development Safety Update Reports (DSURs)**: Annual submission required (ICH E2F format).
- Reports via electronic systems (e.g., Ezdrug portal); sponsor responsibility for monitoring, causality assessment, DSMB (if applicable), and communication to MFDS/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle scheme, but active PMS for high-risk products (e.g., biologics, vaccines).
- Emphasis on electronic reporting (KAERS/E2B(R3)), HCP/patient submissions, and inspections.
- Post-marketing surveillance (PMS) mandatory for new drugs (often 4–6 years or life-cycle RMP-based).

South Korea's PV framework is ICH/EU-harmonized, enforcement-oriented, and one of Asia's strongest (mandatory local representative, PSMF, 15/90-day ICSR timelines, routine PSUR/RMP, expedited SUSAR/DSUR). It balances robust post-marketing obligations with efficient approvals.

For precise, product- or trial-specific details (e.g., latest forms, exact timelines in MFDS ordinances, or KAERS submission), consult **MFDS** directly via mfds.go.kr (English site: Drugs > Pharmacovigilance) or KIDS (kids.or.kr), as requirements evolve (e.g., 2025 approval reforms). Companies often appoint a local agent and align with MFDS guidelines for compliance in South Korea.

 

Address:

Institute of Drug Safety & Risk Management. 5th floor, 30 Burim-ro, 169beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do

Tel.+82-2-2172-6700

Fax.+82-2-2172-6701

E-MAILkids@drugsafe.or.kr

The Korea Adverse Event Reporting System (KAERS)

KAERS is a system developed by KIDS to facilitate reporting and management of adverse event (AE) reports. All reports of AEs have been accumulated in KAERS since 2012.

Suspected drug and AE information are reported to KIDS in a form named ‘Individual Case Safety Reports (ICSRs)’.

AEs can also be reported via ADR call centre and other routes such as fax and e-mail. However, all information received are stored within KAERS as an ICSR. KIDS detects and evaluates signals from cumulated data to generate and provide drug safety information. KAERS database is compatible with the international standards,      and the WHO-UMC (Uppsala Monitoring Centre) international drug monitoring program.

The minimum criteria for an adverse event report to be valid are AE information, drug information, patient and reporter information.

  KIDS periodically provides the Ministry of Food and Drug Safety (MFDS) with AE report statistics and safety information generated.

Who reports to KAERS?

• Anyone who experiences AEs can report to KIDS using KAERS; Consumers, Healthcare Professionals (HCPs),      Regional Pharmacovigilance Centers (RPVCs) and Marketing Authorization Holders (MAHs), who are mostly pharmaceutical companies.

• Regional Pharmacovigilance Centers (RPVCs) evaluate causal relationships of AE reports submitted to their center within the region and reports them to KIDS via KAERS.

• Pharmaceutical companies report AEs via KAERS as well, especially the mandatory reports required by the pharmaceutical regulation.

What kinds of reports are submitted to KAERS?

• KIDS collects domestic and foreign ICSRs and manages the quality of the reports via KAERS. Submission of foreign ICSRs has been made mandatory since Aug 2014 for the MAHs, as an effort to manage safety information comprehensively.

• KAERS database includes the data collected through spontaneous reports, reports from studies(re-examination, post-marketing studies, individual case studies, etc), and literature information

Source: https://www.drugsafe.or.kr/