This thesis aims to investigate the role of national medicines agencies on the innovative scope and productivity of national pharmaceutical small and medium-sized enterprises (SMEs) through comparative case study of Norway and Sweden. Institutional theory and resource based view are used to investigate the influence of institutional forces and strategic resources on shaping the roles of the agencies. The findings indicate that both factors have influenced the roles of Swedish medical products agency (MPA) and Norwegian medicines agency (NOMA). MPA seems to have an innovation facilitation role whereas NOMA does not. However, the Norwegian SMEs within drug discovery and development seem to perform better regarding innovative scope. The innovative productivity among Norwegian biopharmaceutical SMEs also appears to be on the rise. It is suggested that control variables, such as governmental initiatives on funding and tax benefits, have stronger influence on innovative scope and productivity compared to the role of the national medicines agency. Norwegian SMEs regularly seek guidance at medicines agencies in other countries. It is discussed that NOMA can contribute to an even higher performance of Norwegian SMEs if the agency changes its role towards more innovation-orientation and acts as a supporting organization. The practical implications of this research for NOMA have been elaborated.