Regulatory Guidelines for the Use of Artificial Intelligence in the Pharmaceutical Industry
January 16, 2026
Artificial Intelligence (AI) is becoming increasingly significant in the pharmaceutical sector, aiding in drug research, clinical trials, and side effect detection. The two major regulatory authorities, EMA and FDA, have agreed on ten principles for the use of AI, ensuring that decisions remain under human responsibility. The aim of these principles is to develop safer drugs and improve transparency in their approval process. Additionally, their implementation seeks to enhance international collaboration and avoid differing regulations in various countries. The economic aspect of the pharmaceutical industry also remains crucial within this regulatory framework.