EMA Management Board Continues to Monitor Critical Shortages of Medicines

The March 2023 meeting of the Management Board of the European Medicines Agency (EMA) provided an update to the ongoing efforts of the agency’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to further monitor several critical shortages of medicines in the European Union/European Economic Area (EEA), specifically medicines containing the antibiotic amoxicillin.

The previous board meeting focused on the MSSG encouraging EU Member States to consider national regulatory flexibilities to allow the distribution of medicines that may not be authorized in their Member States. Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.

A new executive body, the Medical Devices Shortages Steering Group (MDSSG), met for the first time on March 15, with the intention to coordinate urgent actions in the EU related to the management of supply-and-demand issues of critical medical devices during public health emergencies. The board was further updated on the Head of Medicines Agencies (HMA)/EMA multi-stakeholder workshop on shortages which took place on March 1 and 2. Approximately 300 participants spoke about the work of the HMA/EMA Task Force on medicines shortages and availability, provided updates on ongoing initiatives in the area, and expressed strong commitment to work together to prevent shortages in the future.

Further, the Board looked at EMA’s annual report for 2022, which showed that EMA recommended 89 medicines for marketing authorization for human use, 41 of which contained new active substances, including the first gene therapy for the treatment of severe and moderately severe hemophilia B and the first medicine for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants.

Source: European Medicines Agency