EMA gained new powers

The new rules will enable EMA to closely monitor and mitigate shortages of drugs and medical devices in critical and public health emergencies, and facilitate faster approval of drugs that help treat diseases that are causing the public health crisis. The adoption of a stronger EMA mandate is part of the European Health Union package, proposed by the Commission in November 2020.

- Today's adoption marks a milestone for Union citizens who expected the EU to put in place the right tools to respond quickly and effectively to health crises. Over the past two years, the European Medicines Agency has been a key body in the EU's response to the COVID-19 pandemic. Its role is mainly to advise, evaluate and approve vaccines and drugs to reduce the risk of COVID-19. We promised this to the citizens of the Union and now is the time to deliver on that promise, said Vice-President Margaritis Schinas for Promoting Our European Way of Life.

- Today we are taking an important step towards the creation of a strong European Health Union. The European Medicines Agency is a regulatory body with a worldwide reputation. She spearheaded the work of the EU to ensure that safe and effective vaccines and drugs reach our citizens during the COVID-19 pandemic. Thanks to the strengthened Agency, we can ensure the continued availability of essential medicines and medical devices to citizens and ensure that new emergency drugs are approved more quickly. A strong European Health Union is a goal that we all strive for - both the Member States and the European Parliament. I would like to thank you for this commitment and dedication to advancing this important work, wrote Health and Food Safety Commissioner Stella Kyriakides in her statement.

Through its enhanced mandate, EMA will be able to facilitate a coordinated response to health crises at EU level by:

• monitoring and eliminating the risk of shortage of critical drugs and medical devices;
• providing scientific advice on drugs that can be used to treat, diagnose and prevent the diseases that cause these crises;
• coordinating research to monitor the efficacy and safety of medicinal products for the treatment, diagnosis and prevention of diseases related to the public health crisis;
• coordinating clinical trials of products for the treatment, diagnosis and prevention of diseases related to the public health crisis;
• Transfer of expert panels for the Medical Devices Regulation to the Agency.

The document also officially establishes the Drugs and Medical Devices Steering Group and the Emergency Task Force to deal with the above tasks.

After today's official signature of the regulation by the European Parliament and the Council, it will be published in the Official Journal of the European Union. The regulation will enter into force the day after its publication and will apply from March 1, 2022. The rules laid down in the regulation on monitoring the shortage of medical devices, with the exception of the transfer of expert panels, will apply 12 months after the regulation enters into force.

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