Filenews 16 January 2026 - by Marilena Panayi
Artificial Intelligence in the field of medicines: In the research for new formulations, in clinical trials, in production, in the detection of side effects and in the monitoring of the safety of a drug after its launch begins.
A necessary condition is human intervention and rule, the application of ten basic principles which, as announced yesterday, were agreed by the world's two largest pharmacoregulatory authorities: the European Medicines Agency (EMA) and the corresponding American authority, the FDA.
The goal is safer medicines, faster development of new treatments, better detection of side effects and greater transparency in the way medicines are approved.
In practice, the application of the same regulations to the use of Artificial Intelligence in the field of medicines with the ultimate goal, of course, to exercise control or to the use of the same tools, based on the same criteria in the pharmaceutical industry on both sides of the Atlantic. Simply put, the world's two largest pharmaceutical regulatory authorities, Europe and the US, have agreed on common rules on how Artificial Intelligence can be used by the pharmaceutical industry internationally, since the ten principles recorded are considered to ensure that pharmaceutical companies do not follow different rules in each country, strengthen international cooperation and avoid "grey zones" in the use of Artificial Intelligence.
Of course, the economic aspect must always be added to the equation, since in this way, equality between the pharmaceutical companies that are constantly in competition with each other is ensured. After all, the global turnover for medicines cannot be underestimated.
The use of Artificial Intelligence in the field of medicines is certainly not something that is starting right now. Already, it is increasingly used in research and development of new treatments, in clinical trials and certainly in production.
Through the agreement, it is ensured that Artificial Intelligence is not used uncontrollably, the data analyzed through it is reliable and tested, drug decisions are not made by "algorithms but with human responsibility" and that patient safety remains a primary goal.
The ten basic principles:
1. Artificial Intelligence supports decisions, but does not replace them. The final responsibility remains with people and authorities.
2. Every Artificial Intelligence system must have a clear and specific role (e.g. research, clinical trials, safety).
3. The data given to the Artificial Intelligence must be accurate, representative, and appropriate for the purpose of use on a case-by-case basis.
4. It must be possible to explain how and why an Artificial Intelligence system results in specific results.
5. Artificial Intelligence systems must be thoroughly tested and tested before being used in critical processes.
6. The performance of Artificial Intelligence must be constantly monitored, because data and conditions change over time.
7. There must be mechanisms in place to identify errors, discrepancies or biases in the results.
8. Artificial Intelligence systems must protect personal and sensitive patient data.
9. Artificial Intelligence should not create discrimination or inequalities, e.g. against specific groups of patients.
10. The use of Artificial Intelligence must be fully compatible with pharmaceutical and digital legislation in Europe and the USA.
In essence for patients, according to what was announced yesterday, the application of the ten basic principles means that the data around the drugs under investigation will be analyzed more, decisions on the approval of new treatments will be made faster and possible side effects will be identified and managed more early.
Officially, therefore, Artificial Intelligence is now dynamically entering the field of medicines, with specific rules and comes to be added and rather facilitates the implementation of what the new European legislation on medicines already provides and concerns the way in which pharmaceutical companies must behave.
