In recent years, artificial intelligence (AI) has evolved from an experimental technology into one of the key drivers of transformation in the pharmaceutical industry and the healthcare system as a whole. Machine learning and big data analysis algorithms are used at all stages of the drug life cycle—from molecular target discovery and molecule design to clinical trials, pharmacovigilance, and personalized therapy. At the same time, AI is increasingly being used directly in medical practice: in diagnosis, disease progression prediction, clinical decision support, and robotic surgery.

Such widespread implementation of AI is accompanied by significant legal, ethical, and regulatory challenges. These include the opacity of algorithms ("black box"), the risk of systematic errors and data bias, issues of liability allocation between the physician, the medical organization, and the developer, as well as the protection of patients' personal medical data. This review combines an analysis of AI regulation in pharmaceuticals and medicine in Russia, the European Union, and the United States with practical cases of AI use and court practice, forming a comprehensive picture of the current state and trends in development.

Stricter score criteria for EV chargers and converters begin in 2026, followed by new rules for Russian bearings in machine tools from July 2026.

On November 20, 2025, a series of bills aimed at comprehensively updating regulations in the field of countering the illegal use of insider information and market manipulation were submitted to the State Duma of the Russian Federation. The amendments affected the Law on Insider Information and the Law on Organized Trading, as well as related provisions of the Code of Administrative Offences and the Criminal Code of the Russian Federation. The legislative initiative was introduced by a group of State Duma deputies together with senators of the Russian Federation.

On 27 November 2025, Decree of the Government of the Russian Federation No. 1894 “On the Approval of the Rules for Coordinating with the Federal Security Service of the Russian Federation the Participation of Foreign...” (hereinafter referred to as the “FSB Coordination Rules”) was published. It stipulates that civil-purpose scientific research, experimental design, and technological work (hereinafter referred to as “Work”) involving foreign citizens and foreign organizations, as well as Russian organizations whose participants (founders) include foreign citizens and/or foreign organizations, must be coordinated with the FSB in the fields of scientific and/or scientific-technical activities and experimental development. This coordination is carried out by submitting information to the Russian Ministry of Science and Higher Education through the Unified State Information System for Accounting of Research, Development, and Technological Work (EGISU NIOKTR).

On 24 November 2025, the Delhi High Court issued a judgment in a major patent dispute Medilabo Rfp Inc. v. The Controller of Patents C.A. (Comm.Ipd-Pat) 16/2024, concerning the patent eligibility of a drug for neurodegenerative diseases.

On December 5, 2025, the Bank of Russia announced the partial removal of previously established limits on foreign currency transfers abroad for Russian citizens and individuals who are non-residents from friendly countries. The relaxations came into effect on December 8, 2025.

In June 2024, the pharmaceutical industry faced a new practice by the Federal Antimonopoly Service (FAS), which began to consistently recognize the introduction of generic drugs onto the market as unfair competition.

On 17 November 2025, the Russian Ministry of Health published the Order No. 669n (hereinafter - the "Order") approving the procedure for healthcare professionals to prescribe dietary supplements when providing medical care to citizens.

On October 24, 2025, the Government of the Russian Federation submitted to the State Duma of the Russian Federation Draft Law No. 1050649-8 " On Amendments to the Federal Law "On Investment Partnerships "(hereinafter - the "IP Law") and Fundamentals of Legislation of the Russian Federation on Notaries" (hereinafter - the "Bill").

Stricter score criteria for EV chargers and converters begin in 2026, followed by new rules for Russian bearings in machine tools from July 2026.