This article continues the cycle of publications on the study of history of pharmaceutical law. In the XXI century, the third stage of development of regulation of pharmaceutical sphere began. The introduction of the laws of direct action or regulations, completed the process of harmonization of European regulatory norms with American ones. The implementation of the rules of good practices of research and production of ICH into legislation of countries with developed market of medicinal products ensured unification of technical requirements to safety and quality of medications in the general pharmaceutical market.

pharmaceutical law, medicinal product, the law, regulation, harmonization, historical development..