EMA Eases Drug Safety Data Submission Requirements

Heeding drug industry feedback, the European Medicines Agency (EMA) is reducing the amount of information collected from companies under provisions of the 2010 pharmacovigilance law.

The EMA cut the number of data fields drugmakers must fill out when meeting an annual July 2 deadline for submitting information.

Eliminated are requirements for structured substance information, indication if a product is subject to additional monitoring, location of pharmacovigilance system master file and description of packaging information.

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