EMA: Record number of drugs recommended in 2024

According to a new report from the European Medicines Agency (EMA), 2024 was a record year for recommending new drugs for authorization in the EU. The report also highlights how the agency has adapted to new technologies while navigating a changing and challenging regulatory landscape.

“In 2024, the Agency issued its highest number of recommendations for new medicines and treatments in 15 years,” said EMA Executive Director Emer Cooke. “For the first time since 2009, we delivered over 100 positive opinions, including recommendations for 114 new medicines for human use.

“Among these, 46 contain a completely new active substance, and 16 are for the treatment of rare diseases,” she added.

EMA said the approvals included the first drug to treat early Alzheimer’s disease, a nasal adrenaline for allergic reactions, two new antibiotics, and several new cancer treatments. The agency noted that it issued 28 recommendations for cancer drugs, making cancer the leading therapeutic area that received the agency’s nod. Additionally, the agency also approved treatments for hemophilia B, ALS and the first adult vaccine for Chikungunya.

“There were also 28 recommendations for new biosimilar products, covering a wide range of diseases, including several types of cancer, osteoporosis, macular degeneration and diseases that involve an abnormal immune response like plaque psoriasis, ulcerative colitis and Crohn’s disease,” said Cooke. “This is certainly good for European patients, as biosimilars make treatments more accessible and can provide broader access to potentially life-changing medicines.”

Cooke noted that EMA has also been exploring the burgeoning area of artificial intelligence (AI) to assess how the agency can use it to benefit patients, the overall regulatory system, and the work of its scientists. She noted EMA has published a 2023-2028 multi-annual AI workplan with the Heads of Medicines Agencies (HMA) to help European medicines regulatory network (EMRN) use AI.

As an example of the work they are doing with AI, Cooke noted EMA has launched Scientific Explorer, an AI tool that their regulators can use to support their decision-making and streamline their work.

“As regulators learn more about how best to realise the potential of AI, we need to also understand and educate ourselves about how to manage possible risks, and keep training and preparing our staff for the future,” said Cooke. “As more use cases are implemented, we need to continue to ask the right questions and to challenge and course correct where necessary.”

Cooke also emphasized the EMA's work to harness real-world evidence, such as its efforts to transition the EU to adopt the Clinical Trials Information System; addressing potential product shortages, such as its work to ensure patients had access to GLP-1 receptor agonists used to treat diabetes; and addressing ongoing concerns regarding antimicrobial resistance.

Lorraine Nolan, chair of EMA's management board, noted in the report that last year, EMA and HMA began to update the EMA's network strategy (EMANS) to extend it to 2028. She said the update it intended to respond to the evolving regulatory and technological landscape.

"Our vision is to have a well-resourced, competitive network that leverages technological advances to increase productivity," said Nolan. "By setting measurable goals and objectives, the EMANS to 2028 will keep the network aligned with the evolving healthcare needs within the EU and accountable for the part that it plays."

Nolan also highlighted the work EMA has done to advance CTIS, and AI pilots it is running to evaluate using the technology for medical regulations. She said the pilots have been "very encouraging" and shows promise of helping streamline its regulatory work.

Nolan addressed EMA's work to ensure transparency and collaboration with its regulatory partners. She noted that the agency has updated its policies to address potential competing interests of its scientific
committee members, experts, and management board members.

"These revised policies respond to recent Court of Justice judgments while maintaining our commitment to robust and balanced governance – demonstrating our ongoing commitment to ensuring the highest standards of independence in our scientific decision-making processes," she said.

Bruno Sepodes, chair of the Committee for Medicinal Products for Human Use (CHMP), also highlighted the record number of drugs that EMA had recommended for authorization last year and noted that it had adopted new measures to improve the efficiency of the marketing authorization review process.

"These include the implementation of a standard template for clock-stop extension requests and the update of assessment report templates to improve clarity and reduce duplication," said Sepodes. "We also provided better guidance and training for assessors to ensure consistency and efficiency.

"Automatic email notifications to marketing authorisation holders were also introduced to improve the predictability of post-marketing activities," he added. "Furthermore, we fostered closer dialogue with applicants to address challenges such as the low predictability of submission dates and the high percentage of companies requesting more time to respond to the committee’s questions due to immature data in their applications."

Sepodes said it's important for CHMP to continue to invest in new tools, such as AI, training and be prepared for the upcoming new pharmaceutical legislation to ensure they continue to be able to provide robust assessments. He said it was a "once-in-a-generation opportunity" to streamline and improve the current regulatory oversight process. Furthermore, he said that the implementation of the EU's regulation on Health Technology Assessment (HTA) and the new responsibilities it puts on CHMP will be a challenge.

Annual report

EMA: Record number of drugs recommended in 2024

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