Although Artificial Intelligence (AI) has exploded in popularity in the last couple of years with more applications traversing sectors, concerns about pre-existing biases, ethical issues, and lack of transparency—particularly when working with Artificial and Machine Learning (AI/ML)—have impeded its full adoption in heavily regulated industries like pharmaceuticals due to the stringent regulatory requirements that demand thorough validation, reproducibility, and transparent documentation.
Although regulatory bodies like the FDA and EMA have been observant of the radical growth and adoption of AI technologies by the life sciences industry, a comprehensive regulatory framework specifically targeting AI and its industry-wide applications has yet to materialize. While the exact timeline for introducing such a framework remains unclear, there is no doubt that the new regulation will prioritize enhancing current AI standards, mitigating bias, ensuring explainability and reproducibility, and enhancing overall safety measures.