EU Approach to Safety: Vox Populi or Vox Dei?

In late February, the European Union announced it was launching a review of its rules on pharma-covigilance. It is not surprising that the EU should decide a review of pharmacovigilance is necessary. This is a constantly evolving discipline requiring constant alertness to how well it is meeting the objectives set for it.

What is surprising is the way that the EU chose to justify it in the formal announcement. In a statement entitled "Strengthening Medicines Safety Monitoring," it said: "A public consultation shows that the current EU system of medicines safety monitoring (pharmacovigilance) needs rationalization and strengthening."

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