OBJECTIVES: In July 2012, the European Medicines Agency (EMA) established the Pharmacovigilance and Risk Assessment Committee (PRAC). The PRAC recommends and advises on any questions of pharmacovigilance activities related to a medicine for human use and on risk management systems. This study describes PRAC’s activities to date. METHODS: Meeting minutes since July 2012 were retrieved from the EMA website. The PRAC received questions attributed to seven categories: EU referral procedures for safety reasons, signals assessment and prioritization, risk management plans (RMPs), assessment of periodic safety update reports (PSURs), post-authorisation safety studies (PASS), product-related pharmacovigilance inspections, and other safety issues for discussion requested by the Committee for Medicinal Products for Human Use (CHMP) or Member States (MS). RESULTS: There were 13 meeting minutes available (July 2012 – October 2013), containing1077 questions/requests with/without a formal decision-making phase [149 (13.9%) in 2012, 928 (86.2%) in 2013]. Three request types comprise nearly 80% (n=860): signal assessment and prioritization [n=140 (13%), 50 (4.7%) in 2012, 90 (8.4%) in 2013], RMPs [n=416 (38.7%), 48 (4.5%) in 2012, 368 (34.2%) in 2013], and PSURs [n=304 (28.2%), 20 (1.8%) in 2012, 284 (26.4%) in 2013]. PRAC outputs were recommendations or advice. In 2012, there were 46 recommendations for 35 new signal assessments requests. Recommendations regarding new signals were made either to the Marketing Authorization Holder (MAH) (n=32) (e.g., submit a cumulative review of dermatomyositis within 30 days), the EMA (n=6) (e.g., review cases of dermatomyositis and report back), the PRAC rapporteur (n=7) (e.g., assess the UK cases in the ongoing PSUR procedure) or the MS (n=1) (e.g., UK to provide a report on the nicotinic receptor mutation). CONCLUSIONS: After an initial “running-in period”, the PRAC appears to be fulfilling its mandate. PRAC operations should be evaluated in terms of success (i.e., impact of decisions).