**3. Pharmacovigilance regulatory framework of South Korea**

The spontaneous reporting system for ADR in Korea was started by the Korea Ministry of Food and Drug Safety (MFDS) in 1988. Korea entered the WHO-UMC in 1992 and has been involved in international drug monitoring since then. Since 1995, Korea initiated a re-examination of the safety of newly approved drugs, that is postmarketing surveillance. The year 2000 witnessed enabling of web-based reporting as a system for adverse event reporting. Since 2003, all manufacturers and pharmacists have been required to report all adverse drug reactions (ADRs) to the


**Table 1.** *Market statistics for selected countries.*
