Evolving medical research and treatment modalities have been channeled into safe and effective therapies for the welfare of the public by means of laws and regulations and their periodic modernizations. A regulated environment also creates a fair place for industry stakeholders to compete. The United States Food and Drug Administration as well as Health Canada, both federal agencies, have been instrumental in bringing new therapies to their respective countries. The granularity of regulations, need for evidence, and associated costs increase as the risks associated with the use of these products increase, with prescription drugs being the most challenging and cosmetics being the least. The International Conference on Harmonization made it possible for countries to develop common guidelines, and for the industry to submit mostly the same dossier to multiple countries. Getting an approval to sell a drug is the start of a journey of continuing compliance and demonstration of adherence to the country’s laws and regulations.