BRIEF—EMA's PRAC September meeting highlights

7 September 2018

At its monthly meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) did not start or conclude a new referral. More information on all safety reviews currently under evaluation is provided in the table below.

PRAC elects new vice chairman

The Committee elected Dr Martin Huber from Germany as the new vice chairman to take over from Dr Álmath Spooner.

Dr Spooner has served for two three-year mandates, the maximum allowed by the legislation.

The EMA thanked Dr Spooner for the dedication and knowledge that she put at service to ensure the safety of medicines in the European Union.

Dr Huber is head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors' at the BfArM (Federal Institute for Drugs and Medical Devices), in Germany. He has been a member of the PRAC since its inception in 2012.

This month, the PRAC also focused on the broad range of its responsibilities which cover all aspects of the risk management of the use of medicines.

Ongoing referrals

Procedure

Status

Update

Article-31 referral: Quinolone- and fluoroquinolone-containing medicinal products

Under evaluation

PRAC continues its assessment

Article-31 procedure: Methotrexate containing medicinal products

Under evaluation

PRAC continues its assessment