At the 11th All-Russian GMP Conference, Dmitry Galkin, Director of the Department for Development of the Pharmaceutical and Medical Industry at the Ministry of Industry and Trade, discussed the timeline for the transition to the updated drug manufacturing approval system. The changes are based on Federal Law No. 331-FZ of August 4, 2026, which will take effect on December 1, 2026, and amends Federal Law No. 61-FZ “On the Circulation of Medicines.”
What’s changing?
It is not the fact of production itself that will be confirmed, but rather individual stages of the technological process, provided that they are carried out within the territory of the EAEU.
The production stage document is transformed into a special register entry: the information is entered into the state register, rather than being recorded as a separate paper document, as before.
Before entering information, a review stage is required: the applicant’s submitted documents and information are verified to ensure they meet the requirements specified in the stages. Based on this review, a decision is made to include the data or reject it.
The registry also becomes a tool for confirming the origin of products and the degree of localization of production in the EAEU, and therefore will be used in the implementation of industrial incentive measures.
Key dates
- July 1, 2026 — start of the transition: the RRPP/ST-1 records and the SP document for the full cycle, including the 15% preference, continue to be valid;
- December 1, 2026 — Federal Law No. 331-FZ comes into force: the SP document is converted to a registry format, while the previous mechanisms for confirming origin and production, including the RRPP/ST-1, are retained; for full-cycle drugs in the EAEU, the SP document remains, but confirmation is processed through a registry entry;
- May 1, 2027 — expiration of the validity period of current records for the finished dosage form.
Digital confirmation of series
Manufacturers connect their ERP systems to the Honest Sign component of the State Information System for Pharmaceutical Trade (GIS MT). Data for each batch is verified against external sources, after which the status is determined—either full-cycle production or production without active ingredient synthesis. Starting December 1, 2026, customers will be able to verify the specific batch of the supplied drug against the registry, and information on batches confirmed as full-cycle production will be published on the Ministry of Industry and Trade’s website.
Transition period
Until May 1, 2027, the old records for finished dosage forms will operate in parallel with the new model, after which production confirmation will completely switch to a registry-based and digital system.
