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Building EU Capacity to Monitor the Safety of Drugs

  • Eva Heims
Chapter
Part of the Executive Politics and Governance book series (EXPOLGOV)

Abstract

The chapter analyses to what extent UK and German medicines regulators support the European Medicines Agency (EMA) in its drug safety monitoring task. The EMA builds regulatory capacity in this field by collecting and evaluating reports on adverse drug reactions. German regulators (BfArM and PEI) proactively participate in EMA’s drug safety monitoring committee to get access to data and expertise that is difficult for them to get at the domestic level. The UK regulator (the MHRA) participates not because it helps it to handle a key regulatory challenge, but because it helps it to retain its ‘gold standard’ status in its peer group of regulators. EU regulatory capacity in drug safety monitoring is thus built through a process of epistemic competition between national pharmaceuticals regulators.

Keywords

Drug safety monitoring Pharmacovigilance EMA MHRA BfArM 

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Copyright information

© The Author(s) 2019

Authors and Affiliations

  • Eva Heims
    • 1
  1. 1.Department of PoliticsUniversity of YorkYorkUK

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