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Current issues in drug regulation

  • Marcus Müllner
  • Hans-Georg Eichler
Chapter

2

The role of drug regulatory agencies is to protect and promote public health. In everyday practice, this broad mandate translates into two distinct objectives: first, into an obligation to protect patients against ineffective or harmful drugs, and second, to protect patients against the consequences of untreated disease. The first objective results in a gatekeeper function and obliges regulators to apply stringent standards of assessment and to deny marketing authorization where deemed necessary. By contrast, the second objective requires regulators to support and enable drug development - with a view to ensuring that patients have access as early as possible to safe and effective drugs.

Keywords

European Union market authorization human medicinal products regulatory affairs centralized procedure Mutual Recognition Procedure Decentralized Procedure risk-benefit assessment relative effectiveness pharmacovigilance signal detection 
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Copyright information

© Springer-Verlag/Wien 2010

Authors and Affiliations

  • Marcus Müllner
    • 1
  • Hans-Georg Eichler
    • 2
  1. 1.AGES PharmMed/Austrian Medicines and Medical Devices AgencyViennaAustria
  2. 2.EMA - European Medicines AgencyLondonUK

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