Euro Convergence: Officials discuss AI in regulatory, hope pharma legislation will streamline combo product review

BRUSSELS – Officials said their organizations are evaluating the use of artificial intelligence (AI) for regulatory purposes but cautioned that the technology is still prone to errors, and that human review is needed to ensure accuracy. They also expressed hope that the EU pharmaceutical legislation will provide a streamlined pathway for combination products.

A panel of regulators and representatives of notified bodies took to the stage at RAPS Euro Convergence 2025 to answer audience questions about regulations in the region. One of the attendees asked the panelists about their thoughts on how AI could be used to write regulations and guidance documents.

Coen Brummer, a member of the board of directors at the Dutch Ministry of Health, Welfare, and Sport, said the ministry is exploring AI and noted that, like other organizations, there are believers and non-believers. Personally, he said he tends to be skeptical of new things and noted that AI may be useful in reviewing public feedback. He said that the Dutch government may receive hundreds of factual questions when it proposes a budget, and AI could be used to review them more efficiently.

"From a personal point of view, I don't think you can outsource politics, if that's what we're talking about when it comes to legislation," said Brummer.

Steffen Thirstrup, chief medical officer at the European Medicines Agency (EMA), said AI won't replace human intelligence because people still need to curate and ensure the accuracy of what machines produce. He warned that in some instances; AI has produced false information that required humans to check the results for accuracy.

Thirstrup noted that the research directors of the 15 biggest pharmaceutical companies have said they use AI in drafting their submissions, which has reduced their submission writing staff and shortened the time it takes for them to write the documents. However, he also noted that he's concerned that some of the AI may have "written in hallucinations" that could result in significant errors.

"We are also looking into how we can use AI on our end of things," said Thirstrup. "It is there, we cannot ignore it, but we need to make careful implementations, so we don't get fooled."

Suzanne Halliday, vice president of regulatory and global regulatory compliance at BSI, said that notified bodies are already assessing the use of AI, though she raised concerns about AI's accuracy and noted an example where the technology gave her very inaccurate and different answers.

"I don't trust it yet, I still have to read it myself and make my own decisions," said Halliday. "That's where we all are, we're starting to play, but we still have to do the job of a human."

The experts were asked how they foresee the evolution of combination product regulation.

Alberto Ganan, head of the committees and quality assurance department at EMA, noted that there are a lot of questions regarding the interplay of combination product regulation in the Medical Device Regulation (MDR) and the EU pharmaceutical legislation, as well as the interplay with various stakeholders that need to be addressed. He said that he foresees that there will be efforts to improve communication channels on the operational level between key players such as notified bodies, medical device authorities, and the EMA to address combination products. He also said he's looking forward to the pharmaceutical legislation, which he said will enhance communications and aid in combination product oversight.

Christelle Bouygues, senior regulatory affairs specialist at EMA, echoed the comments and said that EMA could provide more scientific advice, and the pharmaceutical legislation may allow for interactions beyond regulators. However, she also noted that combination product manufacturers currently can ask for certain scientific advice regarding their products, but questions specific to the device's performance are outside the scope of what they are able to address.

Halliday highlighted the European Union's ongoing COMBINE program, which aims to streamline combined studies for pharmaceuticals, medical devices, and in vitro diagnostics (IVDs). She said the IVD notified bodies are pleased with the progress. She also said regulators need to map a pathway based on the program to get combination products to market, especially for medical devices, because many innovative medical device-based combination products are coming down the pipeline.

One of the attendees also commented that the US Food and Drug Administration (FDA) regulates combination products differently from the EU. In the US, FDA determines the combination product’s primary mode of action and assigns a product center to lead the review based on that decision. Furthermore, they noted that the system also allows for more streamlined communication with the product sponsor and asked if EMA notified bodies were similarly considering streamlining the combination product pathway in the EU.

Ganan said that in the second phase of the COMBINE initiative there is a specific model looking at scientific advice and EMA is evaluating what opportunities it may offer to streamline the process. Furthermore, he said the agency is looking at involving different notified bodies and taking a multi-stakeholder approach to provide scientific advice, but noted the legislation currently doesn't allow such an approach. However, he said they are hopeful the pharmaceutical legislation may provide a new framework that allows them to take initiatives within the context of MDR and IVDR to streamline the pathway.

"In the meantime, I think what is important is just also to have a contact point," said Ganan. "The agency has the innovation task force where developers can come and we can say what we can help with, maybe what we cannot, and also try to address the relevant authorities.

He also said it's important to build relationships with all the different stakeholders so that they are prepared when legislation allows for a change in the way they provide scientific advice.

Euro Convergence: Officials discuss AI in regulatory, hope pharma legislation will streamline combo product review

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