1.5 billion rubles will be allocated for the development of a subsystem of drug registries in the Unified State Health Information System

According to the terms of the contract, the work will be carried out in three stages until December 30, 2026. In 2025, 524.65 million rubles will be allocated, and in 2026 - 969.74 million rubles. The contractor must develop, test and upgrade the subsystem at the location in remote mode. The work must be carried out in accordance with national and state standards regarding design requirements, stages of creation, types, completeness and designation of documents, types of tests in the development of state information systems.

The objectives of the work, as seen by the regulator, are to ensure that the Russian Ministry of Health provides state services for the circulation of medicines and maintains a subsystem of registers of medicines for medical use as part of the Unified State Health Information System.

According to the description of the procurement object, the subsystem is designed to collect information and record registered drugs and pharmaceutical substances, registered maximum selling prices, issued permits for clinical trials, data on the import of unregistered drugs, import or export of biomaterials obtained during clinical trials. The subsystem should be aimed at automating the processes of providing government services during the registration and circulation of drugs, maintaining and publishing registers of the results of their provision, as well as providing applicants with electronic extracts on the decision.

The objectives are to ensure the migration of data from the State Register of Medicines system to the subsystem of medicine registers in the Unified State Health Information System, as well as information interaction in terms of synchronizing updated data between the specified structures. During the work, it is necessary to achieve a number of indicators. Thus, in 2025, the share of drug registration certificates for which state registration was carried out using the subsystem should be 2%, in 2026 - 10%.

It is necessary to ensure 100% transfer of several services in the field of drug circulation to electronic form at once - for registration of maximum selling prices for drugs from the VED (in the format of the registry model), registration/re-registration of drugs, and clinical trials.

The contractor must also develop new components that ensure automated processes of the subsystem in terms of providing government services, including “certification of authorized persons of manufacturers of medicines of the member states of the Eurasian Economic Union”, “import and export of biomaterials”, “import and export of medicines”, “state register of biomedical cell products”, “register of permits for conducting clinical trials”, “register of commodity items” and a number of others.

Each component should consist of four modules: "accounting of applications", "accounting of results of service provision", "interaction with related components and subsystems of the Unified State Health Information System" and "interaction with external systems". The subsystem will operate in four modes: normal, emergency, test and system administration mode.

“Work on developing the EGISZ in terms of the subsystem must be carried out taking into account the established levels of information security: the first security class (K1) as a state information system, the second level of security (UL 2) as a personal data information system, the second category of significance as an object of critical information infrastructure, and also taking into account the list of current threats to information security established in the EGISZ Information Security Threat Model and the EGISZ Information Security Violator Model,” follows from the procurement description.

The contractor should ensure the specified levels of protection without changing the configuration of software and hardware. After modernization and deployment, the subsystems must undergo additional certification tests.

At the end of May 2025, Russian Prime Minister Mikhail Mishustin signed a decree approving the rules for maintaining a federal register of individuals with certain diseases. It will be launched in March 2026 to track statistics on certain types of diseases - the platform will become part of the Unified State Health Information System. The register intends to include information on cancer patients, patients with diabetes, common cardiovascular pathologies and other conditions, as well as information on pregnant women. The creation of a subsystem is necessary to track critical morbidity rates, as well as to manage the volume of funding for medical care and preferential drug provision.