The President of the Russian Federation signed Federal Law No. 331-FZ of August 4, 2026, which introduces a registry-based approach to confirming drug production stages. Simultaneously, amendments affected a number of other regulations, emphasizing the systemic nature of the pharmaceutical regulation reform.
The essence of the changes
Instead of disparate permitting procedures, information on technological operations performed by a specific manufacturer will be centrally recorded in a specialized information resource. This approach ensures:
– unified storage of data on production stages;
– increasing the transparency of the production chain;
– standardization of the format for presenting information for regulatory purposes.
The role of the Ministry of Industry and Trade
The Ministry is responsible for maintaining the register, conducting examinations of documents on production stages, and making decisions on the inclusion or refusal of information.
Regulatory and industry significance
– Reducing administrative burden. The registry model replaces multiple confirmations with a single entry of up-to-date data, consistent with the move toward digitalization of control.
– Strengthening traceability. A unified registry allows for rapid verification of which stages are being performed at a specific site, which is important for inspections and quality risk assessments.
– Alignment with EAEU approaches. Standardization of production stage accounting facilitates the harmonization of requirements and simplifies interaction with regulators in other Union countries.
– Impact on contract manufacturing. Contract sites and marketing authorization holders (MAHs) are faced with the need to formalize and update data on the distribution of stages between sites.
Practical recommendations
It is advisable for market participants to:
– conduct an inventory of current production schemes and determine the list of stages subject to confirmation;
– assess the need to adjust master files, registration dossiers and internal regulations;
– establish cooperation with the Ministry of Health and the Ministry of Industry and Trade to obtain clarification on the application of the new procedure.
