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Europe's pharmacovigilance maze

Although by some measures the EU believes it has led the world in pharmacovigilance, drug safety monitoring in Europe has been hampered by a maze of different regulations and responsibilities.

Depending on a drug's approval pathway, different sets of pharma-covigilance regulations apply in Europe. Drugs can be approved in one of three ways: independently by individual countries; via the mutual recognition procedure under which a national approval is expanded to other member states, or via the centralized procedure through the EMEA. For each type of approval there are different laws and regulations and different responsibilities on the national and European level.

As an example, depending on where and under which procedure a drug

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