Preparing Europe for future health threats and crises ─ the European Medicines Agency; ensuring safe and effective medicines and medical devices.

Despite the absence of an explicit legal mandate and appropriate resources, EMA quickly introduced a structure to coordinate activities and established processes which were crucial for an effective EU-wide response. For example, EMA coordinated the exchange of information and actions to identify and mitigate medicine shortages between EU countries when global pharmaceutical supply chains were disrupted almost overnight because of border closures and lockdowns and there was an increased demand for medicines, particularly in the intensive care unit setting. However, it became clear early in the pandemic that EMA needed stronger legal tools to help ensure the availability of medicinal products and medical devices and to support the development of new therapeutics to protect the health of Europeans in times of crisis.