EMA Annual Report: 114 new medicines in 2024

The European Medicines Agency (EMA) – the EU’s drug safety watchdog – approved 114 medicines last year, with 46 of these having a new active substance which had never before been authorised in Europe.

Among these are a number of medicines that stand out due to their contribution to addressing public health needs or the innovation they represent, the Agency said in its Annual Report. Oncology was the area of highest activity, both in the approval of new products and in the extension of therapeutic use of existing drugs.

On the veterinary side, EMA recommended 25 veterinary medicines for marketing authorisation – the highest number of recommendations in a year. Of these, two had a new active substance. Fourteen were vaccines, including seven that had been developed using a biotechnological process.

The Annual Report highlights the Agency’s efforts to invest in better processes and evidence-based regulatory decisions, using initiatives such as Accelerating Clinical Trials in the EU (ACT EU) and the Data Analysis and Real World Interrogation Network (DARWIN EU), facilitating the uptake of advanced manufacturing methods and utilising artificial intelligence for the benefit of patients and public health; and EMA’s work to strengthen collaboration across the European medicines regulatory network and internationally.

Drug evaluation changing fast

The EMA Board also held its annual meeting in June at its Amsterdam headquarters to reflect on 2024 and look ahead at regulatory trends. Bruno Sepodes, chair of EMA’s key human medicines committee (CHMP), presented an overview of achievements and challenges in the committee’s work. ‘2025 is a year of great possibility, with innovative medicines and vaccines advancing through the pipeline,’ said Professor Sepodes.

‘Our regulatory environment is evolving rapidly. The CHMP expects expanded responsibilities from the groundbreaking revision of the EU pharmaceutical legislation; at the same time, advances in science and technology are reshaping how we evaluate medicines, while digitalisation, automation and artificial intelligence will improve and streamline the way we work.’

Professor Sepodes also highlighted the ongoing concerns regarding quality and timeliness of some marketing authorisation applications which can impact regulatory efficiency.