Russian authorities are launching an experimental API traceability system

On Friday, December 29, Russia will begin an exciting experiment to implement a traceability system for the origin of drugs and pharmaceutical substances. It will last until December 31, 2024, following from the Decree of the Government of the Russian Federation No. 2261 of December 22, 2023, which appeared on the official Internet portal of legal information.

Through this system, it becomes feasible to not only confirm the availability of technological capabilities, but also to accurately track and assess the execution of various production stages. “This is an automated digital system that will “pull up” resources from other interdepartmental systems so that we are convinced that the manufacturer <…> really produces everything locally,” Deputy Head of the Ministry of Industry and Trade of the Russian Federation Ekaterina Priezzheva previously explained about the principle of operation.

According to information from the Center for the Development of Advanced Technologies (CRPT, operator of the state labeling system “Honest Sign”), this newly developed mechanism provides the capability to “examine the contents of each tablet.” Thus, as part of a pilot project in Russia, a complete traceability chain will be created – from molecule to consumer – for a number of drugs.

“The creation of a digital automated drug traceability subsystem will allow us to automatically check data on product volume in conjunction with data on the raw materials used from manufacturers and suppliers. If localization is not confirmed, preferences [will] be denied,” the center explained.

Earlier, Dmitry Galkin, director of the Department for Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade, said that the official launch of the system was postponed to 2024-2025. “The current deadline for putting the system into commercial operation is December 31, 2024. And from January 1, 2025, we assume that such a preference could come into force,” he said in October.

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