Abstract Adverse Drug Reactions (ADR) add a significant clinical and economic burden to the healthcare system of a country. Reporting ADRs is the cornerstone of detecting uncommon ADRs once the drugs are on the market. In many countries, ADR reporting is regulated by national regulatory bodies and various methods are employed to report ADRs. Direct reporting by healthcare professionals has been adopted by many developed and developing countries. We present an overview of the different approaches of ADR reporting systems worldwide and their evolution over time.