Overview of the Republic of Korea Pharmacovigilance System : Learning from Best Practices

Building capacity in countries to conduct thorough surveillance of the use of all newly authorized drugs and vaccines, both brand name and generic, is a critical "public good" investment to ensure that drugs work correctly and that their health benefits outweigh their known risks. Korea's pharmacovigilance system (PVS) is an international best practice. It is the result of a continuous and sustained government effort over the past three decades-from small pilot projects to a nationwide monitoring network-and offers valuable lessons to other countries on the vital role that such a system can play in ensuring the safety of drugs post-marketing. This report provides an overview of the Korean pharmacovigilance system, describing its main structural and operational elements, to monitor the safety and effectiveness of medicines. It draws from a review of available literature in journal articles, as well as from the websites and reports of Korean institutions