There is no doubt that AI/ML is definitely in the regulatory spotlight on the medical device side of the industry, but did you know that AI/ML’s impact reaches even the pharmaceutical industry? Due to AI/ML’s ability to analyze large data sets, drug manufacturers are finding ways to optimize new drug products using the novel technology. Just like with medical devices, however, the FDA is still in the infancy stages of learning how to regulate this technology relevant to drug products. This blog will delve into the background of the technology, and its regulatory impact on the pharmaceutical world.
Even though AI/ML still feels like brand new technology, it has been integrated into the drug development life cycle for at least a couple of years now, with more than 100 product submissions reported in 2021 including AI/ML components.[1] These product submissions utilized AI/ML algorithms in areas spanning everything from drug development to clinical research, postmarket safety surveillance, and even advanced manufacturing methods.
AI/ML algorithms can be extremely helpful in the case of real-world data analytics. Manufacturers can potentially use algorithms to crunch the numbers on huge data sets coming from actual postmarket surveillance activities, and have the algorithm suggest or implement improvements in the product formulation or manufacturing processes. This, of course, comes with potentially huge risks that manufacturers and developers need to plan for.
In an effort to keep pace with the technology and industry, the FDA has implemented a number of guidance documents, industry groups, and advisory committees to better understand how the pharma industry utilizes AI/ML, and how to mitigate any risks or challenges that pose risks to public health. This includes a recent discussion paper authored by the 3 major FDA centers: CDER, CBER, and CDRH.
In the coming years, the industry can expect an exponential growth in the use of AI/ML algorithms within the drug development life cycle. With that, the industry can also expect more changes to the regulations to account for the unique challenges posed by the technology. As with medical devices, the FDA will likely require that pharma developers have set software change plans, cybersecurity measures, and a robust risk management plan in place for all AI/ML algorithms.
If you need support with bringing your drug product to market or understanding how AI/ML regulations may impact you, EMMA International can help! Call us at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today!
[1] FDA (May 2023) Artificial Intelligence and Machine Learning (AI/ML) for Drug Development retrieved on 10/23/2023 from: https://www.fda.gov/science-research/science-and-research-special-topics/artificial-intelligence-and-machine-learning-aiml-drug-development
