Regulations to make the EU better prepared to manage future health crises

The European Parliament endorsed the content of the agreement reached with the Council of the European Union in October 2021, which goal is to make the European Medicines Agency (EMA) more effective in tackling shortages of medicines and medical devices by increasing the powers of the EU’s medicines regulator.

Two “shortages steering groups,” for medicines and medical devices respectively will be set up and will meet not only on a regular basis, but also whenever the situation requires, such as in the preparation for or during a public health emergency. The agency will also set up a public webpage with information on shortage of critical medicines and medical devices.

During a public health emergency, sponsors of clinical trials conducted in the EU will be required to make the study protocol publicly available in the EU clinical trials register at the start of the trial, as well as a summary of the results. When a medicinal product is granted marketing authorisation, the EMA will publish product information with details of the conditions of use and clinical data received.

The aim is to better equip the EMA to monitor and mitigate shortages of medicinal products and medical devices considered to be critical to address public health emergencies.

Following the final vote in plenary, the text will be published soon in the EU Official Journal, and the regulation to increase the powers of the European Medicines Agency will come into force on 1 March 2022.

We invite you to read more about it here.

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