4-Year Overview of Pharmacovigilance Activities in the EU Shows Robust and Effective Medicines Safety System

On 17 December 2019 the EMA released the report on the impact of pharmacovigilance measures covering the period 01 January 2015 to 31 December 2018.

A report on the activities ensuring the safety of medicines carried out by EMA and the national competent authorities of the European Union (EU) Member States, Norway and Iceland from 2015 to 2018 shows that the EU pharmacovigilance system is strong and adaptable and has had a positive impact on public health.

The report measures the longer-term impact of the pharmacovigilance legislation, which came into effect in July 2012, in terms of simplification of pharmacovigilance processes, improved transparency and stakeholder engagement and protection of patient health. The measurement of impact is based on a strategy and action plan for measuring the impact of pharmacovigilance activities, adopted by EMA’s safety committee (PRAC) in 2017.

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