DDReg Pharma

Pharmacovigilance services in South Korea

The Korea Institute of Drug Safety and Risk Management (KIDS) is responsible for the identification and prevention of drug-related issues in South Korea and functions under the Ministry of Food and Drug Safety of South Korea (MFDS). KIDS mainly focuses on awareness regarding adverse drug event reporting, investigating the adverse event (AE) information and assessing the causality, developing drug utilization review (DUR) criteria, and percolating this information to the general public. To further ease this process, KIDS has developed a reporting and management system called The Korea adverse event reporting system (KAERS). All the adverse event reports information is stored in KAERS in the form of individual case safety reports (ICSR). Anyone can report AE including the general public, physicians, other health professionals, regional pharmacovigilance centres (RPVC), and market authorization holders (MAH) can report via ADR call centre, fax, and email. The RPVCs are responsible for the assessment of causality for their centres in their regions and further report this to the KAERS. Similarly, pharmaceutical manufacturers submit the report via KAERS, especially in mandatory reporting required by the regulation. In addition to this reporting of foreign ADRs has been mandated for more comprehensive safety information.
As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in South Korea that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
Risk Management Plan
Aggregate Reports
Signal Management
PV Services
PV Audit & Compliance
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