In 2023, EMA recommended the authorisation of 77 medicines for human use, including 39 with a new active substance, according to EMA’s annual report 2023. Among new treatments are also two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV). EMA also recommended for approval the first advanced therapy medicinal product based on the gene-editing technology CRISPR/Cas9 to treat beta thalassemia and severe sickle cell disease. The Agency also adopted two positive opinions for medicines for use in countries outside the EU.

EMA’s three major strategic areas in 2023 were cancer medicines, data-driven medicine regulation, and transparency and communication. The report is also available in a digital version,  allowing users to filter and interact with the data.

EMA also recommended 14 veterinary medicines for marketing authorisation, nine of which based on a new active substance. Among the new veterinary medicines are also six biotechnological vaccines.

In 2023, EMA also launched the new initiative “Cancer Medicines Pathfinder” to further support the development and approval of cancer medicines which could have a significant impact on patient care.