Innovation, Collaboration, and Performance Were Highlights for EMA in 2024

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

In her end-of-the-year message, Emer Cooke, executive director of the European Medicines Agency (EMA) promoted the agency’s successes in 2024, including the recommendation of 114 drugs for approval, collaborations with EU Member States and regulators from other regions, and efforts to combat drug shortages.

The marketing authorization recommendations made in 2024 by EMA included 48 new active substances, 16 of which were for rare diseases. “It is the first time since 2009 that we have been able to deliver more than 100 positive opinions,” Cooke stated in the press release (1). “This is good news for patients, but also a very encouraging indication of the competitiveness of the European pharmaceutical sector.”

Noteworthy marketing authorization recommendations went to the first Alzheimer’s disease medication in the European Union to slow progression of the disease and the first Chikungunya vaccine for adults. A new antibiotic was also approved to fight infections caused by multidrug-resistant bacteria, which is a positive development as antimicrobial resistance continues to be a threat to public health.

EMA collaborated with a variety of partners in 2024 to deal with multiple industry challenges. The agency worked with EU Member States to transition ongoing clinical trials to the Clinical Trials Information System. “Ten thousand applications have been submitted in the system since January 2022. This marks the end of a three-year transition period that began when the Clinical Trials Regulation became applicable,” Cooke stated in the release. The agency also worked with the African Medicines Agency to share experience and knowledge and to support a pilot program for joint evaluation of drugs in Africa.

To combat the ever-present problem of drug shortages, EMA worked with EU Member States in 2024 to ensure medicines were available to patients. Efforts included recommendations to keep the supply of critical vulnerable drugs strong. Communication was increased regarding key drugs, such as glucagon-like peptide-1 receptor agonists. In addition, the European Shortages Monitoring Program was established so that information regarding drug shortages can be exchanged quickly and efficiently between regulators and pharma companies. The Task Force on Availability of Authorised Medicines for Human and Veterinary Use, established in 2016, also concluded its work in 2024. “Fast forward to today, and one pandemic later, the activities started by the group have been enshrined in law and added to our public health mandate. The Task Force can be incredibly proud of what it has achieved, including the just published second version of the Union list of critical medicines,” Cooke stated.

“In 2025, EMA will continue its mission to protect public and animal health—with determination, with enthusiasm and passion. We are tirelessly working on reinventing and improving ourselves,” Cooke said in the release. “Next year, the Agency will maintain its focus on accelerating and optimizing the assessment of key medicines, improving both accessibility and availability of medicines, as well as working on approaches to future-proofing medicines regulation in the EU [European Union] in preparation for the new pharmaceutical legislation. I am expecting 2025 to be another exciting year for medicines regulation.”

Reference

1. EMA. Emer Cooke, EMA’s Executive Director: 2024 Achievements in Medicine Regulation. Press Release. Dec. 17, 2024.