OBJECTIVES: To assess market authorizations of oncology drugs marketed in different countries (Europe, US, Canada, Australia, and UK). The study also compared the regulatory aspects of oncology drugs through orphan designations. METHODS: We started by identifying all oncology drugs approved by the European Medicines Agency (EMA) during the period of 2000 to 2014. To capture the relevant information related to our oncology drugs sample, we reviewed the Summary of Product Characteristics (SmPC) prepared to the regulatory agency. Regulatory information (Market authorization and orphan designation) information was obtained from different regulatory agencies (EMA, Food and Drug Administration [FDA], Therapeutic Goods Administration [TGA], the Swiss Agency for Therapeutic Products [Swissmedic], and Health Canada [HC]). Orphan designations of oncology drugs were compared across different countries. Descriptive statistics was performed. RESULTS: There were total of 56 oncology drugs approved and available in European countries, 50 oncology drugs were registered by the FDA and HC, 48 were available in Australia, and the lowest number (44) of approved oncology drugs was in Switzerland. The First oncology drug approved by the regulatory agency in the study period was trastuzumab in Europe, arsenic trioxide in the US, capecitabine in Australia, and mitotane in Canada. On the other hand, the last oncology drug approved by the regulatory agency in the study period was trastuzumab emtansine in Europe, afatinib in the US, ponatinib in Australia, and Aflibercept in Canada. The numbers of oncology orphan drugs were: 19 approved by EMA, 28 approved by FDA, 24 approved by HC, 30 approved by TGA, and 21 approved by Swissmedic. CONCLUSIONS: There was a rapid increase in oncology drugs approvals around the world in the past years. However, there were huge unmet medical needs in the area of oncology.