EMA amends market approval rules based on pharmacovigilance experience

Reforms cover submission of paediatric medicine studies, among other things

Fresh changes have been made by the European Medicines Authority (EMA) to its market authorisation procedures based on experience gained from the implementation of new European Union (EU) pharmacovigilance rules.

The reforms cover, for instance, the submission of paediatric medicine studies, environmental risk assessments and amendments of deadlines for delivering marketing authorisation conditions.

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