The European Medicines Agency (EMA) achieved a significant milestone in 2024, recommending 114 drugs for marketing authorization, the highest number since 2009. This achievement underscores the competitiveness of the European pharmaceutical sector and brings new hope to patients facing a range of medical conditions.
Key Approvals and Public Health Impact
Among the notable recommendations were 48 new active substances, including 16 for rare diseases. A particularly significant approval was the first Alzheimer’s disease medication in the European Union designed to slow the progression of the disease. This marks a crucial advancement in addressing a condition with limited treatment options. Additionally, the EMA recommended the first Chikungunya vaccine for adults, offering a new preventative measure against this debilitating viral disease.
Another critical approval was a new antibiotic to combat infections caused by multidrug-resistant bacteria. With antimicrobial resistance posing an increasing threat to public health, this new treatment option is a welcome development in the fight against these challenging infections.
Collaborative Efforts and Clinical Trials
The EMA collaborated extensively with EU Member States to transition ongoing clinical trials to the Clinical Trials Information System. By January 2022, 10,000 applications had been submitted into the system, which marks the end of a three-year transition period that began when the Clinical Trials Regulation became applicable. 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.
Addressing Drug Shortages
Recognizing the persistent challenge of drug shortages, the EMA worked with EU Member States to ensure medicines were available to patients. These efforts included recommendations to maintain a strong supply of critical vulnerable drugs and increased communication regarding key drugs, such as glucagon-like peptide-1 receptor agonists. The European Shortages Monitoring Program was established to facilitate rapid information exchange between regulators and pharmaceutical companies regarding drug shortages. The Task Force on Availability of Authorised Medicines for Human and Veterinary Use, established in 2016, concluded its work in 2024, with its activities now enshrined in law and added to the EMA's public health mandate.
EMA's Future Focus
Looking ahead to 2025, the EMA will continue its mission to protect public and animal health. The agency will focus on accelerating and optimizing the assessment of key medicines, improving both accessibility and availability of medicines, and working on approaches to future-proof medicines regulation in the EU in preparation for new pharmaceutical legislation.
