OBJECTIVES: To review, describe and assess models of drug safety monitoring in England, Poland, Italy, Germany, Denmark and in the United States and prepare recommendations useful in health authorities decision-making process. METHODS: A review of documents, materials and information published on national medicines agencies as well as WHO’s statements was conducted, supplemented by hand-search of literature. RESULTS: The advantages and disadvantages of described pharmacovigilance schemes in selected countries has been discussed. The gathered data, related i.a. to the level of adverse drug reaction reporting in different countries, was used to assess the efficacy of national reporting process. Moreover our research allowed us  to value the formula of pharmacovigilance schemes as well as the attitudes of healthcare professionals and patients towards it. CONCLUSIONS: Although the majority of compared countries are European Union members bound to respect the same acts of European law, there are still many significant differences met in Pharmacovigilance practice reflecting in the level of adverse reaction reporting. These differences may be found as the treatment of newly registered medicines, data availability and transparency of procedures within the agencies or the relationship between health authorities and potential reporters. A set of recommendations has been prepared related to special treatment of new medicines, creating awareness of importance of pharmacovigilance inhealthcare (hospitals, pharmacies), changing the attitude to risk aspects, transparency of safety monitoring practice and patients’ enrollment. The implication of our proposals could help to amend the pharmacovigilance systems in all discussed countries.