Under its new mandate, EMA (European Medicines Agency) has responsibilities to monitor critical medicine shortages.
The MSSG (EMA`s Executive Steering Group on Shortages and Safety of Medicinal Products), consisting of representatives from EU Member States, the European Commission, EMA, and observers from patients' and healthcare professionals' working parties, was established to respond effectively to medicine supply issues caused by major events or public-health emergencies. The Health Emergency Preparedness and Response Authority (HERA) was established to prevent, detect, and respond to health emergencies. It ensures the development, manufacturing, procurement, and equitable distribution of essential medical countermeasures. HERA strengthens the EU's health emergency response and preparedness as part of the European Health Union.
The European Commission, the Heads of Medicines Agencies (HMA) and EMA have issued recommendations to prevent antibiotic shortages for respiratory infections in Europe during winter. They complement the EUs list of critical medicines. The focus is on ensuring sufficient oral antibiotics, while collaboration with marketing authorization holders aims to enhance the supply of intravenous antibiotics. Proactive measures include increasing production and monitoring supply and demand. Public awareness and responsible antibiotic use are encouraged. EMA and the Commission will closely monitor the situation and hold discussions with stakeholders. The recommendations are based on data from EMA and HERA. They align with efforts to prevent medicine shortages and develop the EU list of critical medicines. EMA`s new responsibilities include monitoring shortages, while the MSSG addresses supply issues. HERA plays a role in emergency preparedness and response, ensuring access to medical countermeasures and strengthening the EU´s health emergency capabilities.
These actions on antibiotics align with the EU's broader framework to prevent and reduce medicine shortages and contribute to the development of an EU list of critical medicines. The list aims to ensure the availability of crucial medicines across the EU/EEA at all times. The first version of the EU list of critical medicines is expected to be released by the end of 2023.
Source: EC press corner, July 17
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