The operating parameters of the raw material traceability system for drugs have been approved

According to the document, traceability entities will include Russian and foreign companies that are tax residents of EAEU member countries. These companies will conduct activities in Russia that involve the acquisition and sale of starting materials and the production of medicines and must be committed to confirming that all stages of drug production are carried out within the EAEU. Regulators will define "source material circulation participants" as individuals and legal entities that are tax residents of the Russian Federation and that produce, sell, and purchase starting materials used in the manufacture of traceability entities.

The decree requires both categories of companies to possess an enhanced qualified electronic signature and have a hardware and software system for electronic document management with a monitoring system. Registration of market representatives will be based on their applications, which contain the company's name, type, location, tax identification number (TIN), full name of the representative, and other information.

After registration, legal entities are asked to test their own software and hardware to determine whether they can interact with the government platform.

From the day they register in the monitoring information system and undergo testing, companies must submit information about the acquisition and use of source materials specified in the product's industrial regulations. Regulators will use the data from the service to verify the country of origin of drugs for the purposes of granting preferential treatment under the national regime for public procurement.

The adopted document sets out the procedure for the automatic exchange of data between the traceability system and other government systems. Information on pharmaceutical substances will be uploaded to the platform from the Unified State Health Information System of the Russian Ministry of Health, information on medicines will be uploaded from the Honest Sign system for monitoring the movement of medicinal products for medical use, information on chemical substances will be uploaded from open online sources, information on biological substances will be uploaded from the Federal State Information System for Veterinary Medicine, and information on starting materials will be uploaded from the Industrial Product Register.

The draft of the now-adopted document was presented by the Russian Ministry of Industry and Trade in early July 2025. The explanatory note stated that the document was developed to implement the "Pharma-2030" strategy, which "provides for the need to establish priority" for drugs from the list of strategically important medicinal products (SIMs) produced within the EAEU. The document was also prepared through an "experiment, including consideration of the specific technological processes involved in the synthesis of active pharmaceutical ingredients."

The Russian Government approved a resolution to conduct an experiment on the traceability of medicines and raw materials used in their production at the end of 2023. The experiment was initially planned to run from December 29, 2023, to December 31, 2024, but was later extended to June 30, 2025. In April 2025, the completion date was postponed again, to August 31 of this year.

The system was expected to exit test mode by the end of the experiment—September 1, 2025. However, the document was not published until September 26, the same day its implementation date was set.

One of the most important tasks of the traceability system should be the verification of the actual country of origin and the depth of localization of drug production. This data will impact pharmaceutical companies' ability to benefit from the national regime enshrined in the government decree of December 2024. The document's provisions, which extend the "second-wheel" mechanism to state drug procurement, have been criticized by industry and patient communities. Industry associations have expressed concerns, among other things, about the improper functioning of the traceability system.