Knowledge management in the pharmaceutical industry between academic research and industry regulations

The pharmaceutical sector is one of the pillars of the world’s economy. A significant proportion of its value lies in intellectual assets generated through continuous innovation and lengthy development cycles within a strictly regulated environment. The purpose of this paper is to address the gap between knowledge management (KM) as an expanding academic discipline in the pharmaceutical industry and at the same time a growing regulatory expectation. A systematic review of 137 refereed KM articles revealed six empirical research themes in the pharmaceutical industry. In a subsequent step, the discovered themes and subthemes were compared with the extant regulatory expectations as explained in 128 regulatory guidelines. Findings shed the light on the gap between academic KM research and the current thinking of regulatory bodies. Some regulated knowledge processes were underrepresented in academic literature. The paper offers also novel insights and recommendations for future developments in academic research, regulations, and/or industry.