Compendium: Step Toward Design-Oriented Practices in the Pharma Industry in a Multidisciplinary Perspective

In the first chapter of this volume, we began our exploration by stating that “from a regulatory point of view, the pharmaceuticals sector—given the peculiarities of the product and its impact on consumer health—has always been hyper-regulated” (see Chap. 2 and Addendum 1). The power of this regulation stems not only from legislative documents at the EU and international levels but also from national regulations. The regulatory landscape is further complicated by the addition of documents such as Guidelines, Product and Process Regulations, and Recommendations from individual states over time, creating a highly stratified and complex legislative framework in the pharmaceutical field. Throughout the various chapters, regulatory milestones have been revisited, aligning with the topics addressed by different authors (refer to Addendum 1 for the regulations or sections of regulations framing the design of primary and secondary packaging, as well as the package leaflet). Our specific focus is on the role of current legislation in guiding the design of the ‘medicine system’ toward the patients and their needs. As elucidated in the text, the ‘medicine system’ encompasses the ensemble of physical artifacts and information apparatus—primary packaging, secondary packaging, package leaflet—that, alongside the medicine, undergo evaluation by regulatory bodies for its ‘marketing’.