European Risk Management Strategy (ERMS)

The European Risk Management Strategy (ERMS) aims to provide for a more proactive conduct of pharmacovigilance by putting in place measures that allow for the early detection, assessment, minimisation and communication of risks of medicines in Europe throughout their lifecycle.

No effective medicine is without risk and the benefits of a medicinal product always need to be weighed up against its risks. The challenge for regulators is to find the right balance between timely availability of new medicines and the fact that knowledge on the safety profile is limited at the time of marketing authorisation.

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