EMA prepares for winter antibiotic shortages

Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.

EMA prepares for winter antibiotic shortages

The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency have published recommendations for avoiding antibiotic shortages in the Autumn/Winter 2023-2024 season.

These suggested actions have been developed through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). They complement the process to develop an EU list of critical medicines, of which a first version is anticipated to be released by the end of 2023.

The Commission will work with EU Member States to take operational follow-up actions, including, if necessary, possible joint procurements.

Preventing antibiotic shortages in the EU this coming winter

In the report, two of the key recommendations put forward were:

Increase the production of key antibiotics: “It is important that manufacturers take early action, ahead of the winter season, so that they can ramp up manufacturing capacity where necessary,” Emer Cooke, EMA’s Executive Director remarked on the EMA’s first recommendation.

Monitoring of supply and demand: EMA and the Commission, together with Member States will continue to monitor the demand and supplies in cooperation with companies.

The new recommendations for overcoming shortages of these medicines add to suggestions made by the EMA in May 2023.

These guidance and actions given are based on data collected by EMA and the European Commission’s Health Emergency Preparedness and Response Authority (HERA) on estimated demand and supply of several key antibiotics used to treat respiratory infections.

If the demand for antibiotics in the coming winter season is similar to the average level of consumption in previous years, the data collected suggest that supply to the EU of oral formulations of key first and second-line antibiotics for respiratory infections will match demand in the coming winter season.

EMA and the European Health Emergency Preparedness and Response Authority (HERA) will continue to work with marketing authorisation holders to strengthen measures to increase the supply of some intravenous antibiotics.

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