OBJECTIVES: Health outcomes information is being used more frequently by the pharmaceutical industry to demonstrate product value beyond traditional safety and efficacy parameters. We researched country-specific regulations on the use of health outcomes data for product promotion and compared requirements/guidelines across countries. METHODS: We reviewed regulatory documents governing the promotion of medicines and code of practice documents on the enforcement of promotion guidelines. Country-specific examples of promotional material were collected via journal publications, electronic search and through contact with the pharmaceutical manufacturer. RESULTS: Regulations from 15 countries and five regions (North America, Europe, Eastern Europe, Asia and Latin America) were collected. The major distinctions between countries are specific guidelines on the use of health outcomes data, the ability to use qualified data without prior approval, the level of substantiation required for promotional use and direct-to-consumer advertising. CONCLUSIONS: Regulations regarding the use of health outcomes data for product promotion are often combined with safety and efficacy guidelines. There is, however, movement within regulatory bodies to specifically address the use of health outcomes data. Understanding the regulation and use of health outcomes data for promotional purposes is useful for global pharmaceutical companies in developing a comprehensive campaign to demonstrate product value.