*Introductory Chapter: Pharmacovigilance Regulatory Framework of Three Asian Countries… DOI: http://dx.doi.org/10.5772/intechopen.109194*

MFDS within 15 days of the incidence of the ADR. In 2006, the Ministry of Food and Drug Safety (MFDS) declared three university hospitals as Korean Regional PV Centers (RPVCs) to promote spontaneous ADR coverage. In 2007, it became mandatory for all pharmaceutical companies to appoint responsible persons for PVs (RPPV). A well-established PV network was constructed in 2009 including 15 RPVCs across Korea. A national concurrent Medication Use Review system, which covers drug-drug interactions and drug-age contraindications and is a real-time screening system, was developed in 2010 for both physicians and pharmacists. Korea Institute of Drug Safety and Risk Management (KIDS) was created under the MFDS in April 2012, based on the Pharmaceutical Affairs Law' Article 68-3.

In 1988, Korea MFDS launched in Korea the Adverse Drug reaction reporting system. Since then, healthcare providers and patients have been reporting spontaneous ADRs. Despite of first 10 years of lower reporting rates, Korea has managed to accelerate the same after the establishment of KIDS (Korea Institute of Drug Safety and Risk Management) in 2012. Thus KIDS has majorly contributed to Korean Pharmacovigilance.

Healthcare providers, consumers, RPVCs, consumers and pharmaceutical companies are all required to submit reports to KIDS. RPVCs are managed by KIDS and serve a variety of functions, including data collection and causality evaluation on ADR results. It offers drug safety education and serves as a drug awareness hub.

KIDS detects signals by employing the WHO-UMC scale. It also employs a number of data mining techniques, including Bayesian Confidence Propagation Neural Networks. The detection of potential signals can lead to specific regulatory decisions, such as label updates. For a more detailed study of drug usage and disease occurrence, data mining approaches are being extended to include the use of the HIRA database and hospital electronic medical record (EMR) databases.

KIDS is also in charge of determining causality, using a variety of algorithms based on decision criteria such as challenge, dechallenge and rechallenge data, as well as previous bibliographic details and other aetiologic alternatives. For causality evaluation and signal confirmation, pharmacoepidemiologic approaches such as cross-sectional,

#### **Figure 1.**

*Flowchart depicting various drug safety information in kids [5].*

case-crossover, case–control and other cohort studies are used. A Data Utilization Review is well dictated as an "authorized, structured, and continuing program that reviews, analyzes, and interprets patterns of drug usage in a given health care delivery system against predetermined standards."

The Drug Utilization Review (DUR) was created to reduce prescription errors and improve pharmaceutical treatment quality. A DUR informs doctors and pharmacists of the potential for adverse effects of their medications on patients.

Multiple databases, including the Korea ADR report database, HIRA (Health Insurance Review and Assessment Service) claims database, national mortality database, hospital EMR (Electronic Medical Record) database and cancer registry database, will be linked by the Korean national ADR monitoring system. ADR control programmes, such as the US FDA's Sentinel Initiative, will use big data in the near future. A drug injury relief initiative will be introduced, with the aim of determining the causality of adverse drug events.

Thus South Korea after 2012 with the help of KIDS has excellently flourished their pharmacovigilance systems (**Figure 1**) [5–8].
