If directives, laws, and regulations play a fundamental role in constraining the pharmaceutical sector’s production, distribution and communication policies and practices, regulatory devices have also had and are also playing a role in incentivising innovation and orienting it towards socially and environmentally sustainable practices. The chapter builds a review of the principal regulations that, starting from the EU level, are raising awareness in the various countries of the community (here, the Italian case is analysed) towards the issues of the environment (e.g., reduction of the source of packaging materials and redesigning the pack by favouring the use of recyclable materials), traceability for anti-counterfeiting purposes; safety; and the ethics of medicine communication both in advertising and online. The regulatory review constitutes a starting point, deepened in other chapters, through the review of guidelines, recommendations, and soft law tools, to which those involved in design and innovation activities in the sector must refer.