Legality of AI and machine learning in new generation technologies (2.0) for the manufacturing of gene therapy drugs from the perspective of the EU ATMP regulations.

The use of AI and machine learning solutions in drug manufacturing technologies with the use of machine learning and quantitative, high-throughput in vivo experiments; the EU regulations for advanced therapy medicinal products (ATMP) and the procedures for placing the most modern drugs on the world market by the European Medicines Agency.

The intensive development of medicine affects the medical regulatory law in the European Union, which should cover more and more new legal problems related to the increasingly common application of advanced solutions of artificial intelligence, machine learning, telemedicine solutions and cyber solutions to the technology of manufacturing medicinal products.

In the current legal status, however, the legality of the use of such state-of-the-art AI and machine learning technologies in pharmaceutical production should be assessed on the basis of the regulations on the assessment of their final effect, i.e. the level of admissibility of placing ready-made alternative therapy products on the market, as well as the legal aspects of commercialization of such technologies.