A functional and responsive pharmacovigilance system is an essential element of any health system. After a medicine gains regulatory approval and begins to be used by doctors and patients a pharmacovigilance system will monitor the drug’s safety in real world settings by trying to detect, understand, and prevent adverse drugs reactions and other drug-related problems. PATH & partners have assessed Myanmar’s current pharmacovigilance system using WHO’s criteria is provided, as are results of previous research and recommendations to improve the pharmacovigilance system based on the assessment. Data for the review was gathered from databases (e.g. PubMed, Cochrane Library), WHO, national policy documents, domestic studies, and via key informant interviews.