In brief
On 31 January 2022, Regulation (EU) 2022/123 (“Regulation”) on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (EMA) was published in the Official Journal of the EU.
The Regulation entrusts the EMA with new tasks, including the setting-up, maintenance and management of the European shortages monitoring platform, which shall be fully operational by early 2025, to facilitate data collection on shortages in the supply and demand for medicinal products, including information on whether the medicinal product is placed or ceases to be placed on the market in a Member State. Moreover, the Regulation entrusts the EMA with the task of (i) reinforcing the activities of the Emergency Task Force by providing scientific advice and reviewing available scientific evidence on medicines with the potential to address a public health emergency, (ii) coordinating independent vaccine effectiveness and safety monitoring studies using data collected by the competent authorities, and (iii) establishing a pan-European network of real-world data, so-called “DARWIN EU”, which will provide the EMA’s scientific committees with evidence from healthcare databases across the EU.
The reinforcement of the EMA’s role is part of the roadmap for building a European Health Union, an initiative promoted by the European Commission with the aim of improving the resilience of Europe’s health systems in addressing possible future pandemics and ensuring a better protection of citizens’ health.
The Regulation shall apply from 1 March 2022, with the exception of provisions on shortages of critical medical devices, which shall apply from 2 February 2023.
