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Pharmacovigilance Requirements in South Korea



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




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/

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