LEGAL ASPECTS OF THE USE OF ML AND AI IN PHARMACEUTICAL PRODUCTION – POLISH AND EU REGULATIONS
Publication date: January 16, 2026
Pharmaceutical production is one of the most regulated activities in Poland, Europe, and globally. The reason seems obvious: creating drugs can cause numerous complications, health problems, and in extreme cases, even death, depending on the individual patient’s health contraindications. Due to the above-mentioned reasons, the process of creating a new drug is often very expensive and lengthy, and involves a large number of professionals and scientists specializing in this field. In an era of dynamic digitalization, the need to develop specific operational rules for drug production and principles for using AI (Artificial Intelligence) and ML (Machine Learning) models is increasingly emphasized. Manufacturers are often considering implementing AI systems to support pharmaceutical production processes.