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National Competent Authorities As The Reference Member State: Understanding The Variables Affecting Their Regulatory Decisions, Christian Martin
Undergraduate Honors Theses
The pharmaceutical medicines in one member state of the European Union do not belong in any other member state unless that member state’s national medicines agency has approved them. In this paper I look at the two procedures that exist, the mutual recognition procedure and the decentralized procedure. I ask what affects the variation in ease and stringency within the regulatory decisions of the national competent authorities when acting as the reference member state. I hypothesize that institutions and economic political ideology influence the regulatory decisions, leading to more or less finalized procedures. Multi-variate regressions confirm the permeability of ...