European Medicines Agency’s Report for 2022: Protecting and Strengthening Public Health in the European Union
The European Medicines Agency (EMA) (official web-site) published its report for the year 2022. The report provides an overview of the measures taken to protect and strengthen public health in the European Union (EU). The EMA recommended the approval of 89 human medicines, including 41 with new active substances.
The report includes a review of the recommendations by the Agency on COVID-19 and monkeypox vaccination/treatment. It also highlights the actions taken to implement Regulation (EU) 2022/123, which enhances the role of EMA in crisis management of medicinal products and medical devices. According to this regulation, by early 2025, EMA will establish, maintain, and manage the European Shortages Monitoring Platform to facilitate data collection and reporting by companies and member states regarding shortages, supply, and demand of critically important medicines.
The document also mentions the implementation of the Clinical Trials Regulation, which came into effect in January 2022. Additionally, it discusses the successful launch of the Clinical Trials Information System (CTIS) and the “Accelerating Clinical Trials in the EU” (ACT EU) initiative, which change the conditions for conducting clinical trials in Europe. Together, these initiatives contribute to achieving ambitious goals for innovation in the field of clinical trials, as defined in the European Medicines Agencies Network Strategy (EMANS) for 2025 and the Pharmaceutical Strategy of the European Commission.
The report further outlines EMA’s initiatives to transform the regulatory decision-making process by enhancing the potential and opportunities for data analysis and the use of real-world evidence. One such initiative is the launch of a pilot project to assess whether the evaluation of marketing authorization applications can be improved by analyzing “unprocessed data” from clinical trials, particularly regarding the selection of the “target population” of patients.
Strengthening EMA’s Role and Initiatives for Public Health Protection
The European Medicines Agency (EMA) has been actively working to strengthen its role in safeguarding public health in the European Union (EU). In its report for 2022, the EMA highlights several initiatives aimed at enhancing public health protection and improving regulatory processes.
One of the key initiatives mentioned in the report is the establishment of the European Shortages Monitoring Platform. By creating this platform, EMA aims to collect data and enable companies and member states to report on shortages, supply, and demand of critical medicines. This proactive approach will help identify and address potential shortages in a timely manner, ensuring that patients have access to necessary medications.
Another significant development mentioned is the implementation of the Clinical Trials Regulation. This regulation, which came into effect in 2022, aims to streamline and harmonize the processes for conducting clinical trials in the EU. It simplifies the submission and assessment of trial applications, promotes transparency, and ensures patient safety. The successful launch of the Clinical Trials Information System (CTIS) further supports these efforts by providing a centralized platform for the management of clinical trial data.
EMA’s initiatives also extend to the evaluation of marketing authorization applications. The report highlights a pilot project focused on the analysis of “unprocessed data” from clinical trials. By leveraging this data, including information on the selection of the target population, EMA aims to improve the evaluation process and make more informed regulatory decisions. This initiative demonstrates EMA’s commitment to leveraging real-world evidence and utilizing advanced analytical techniques for the benefit of public health.