Domestic Reference Standards: The Foundation of Pharmaceutical Quality Control and Industry Sovereignty

Despite the existence of a multi-level drug quality control system in Russia and EAEU countries, risks persist regarding the market entry of falsified or insufficiently tested medications. Documented cases include imported dietary supplements containing undeclared active ingredients, such as sibutramine - a psychostimulant subject to government control. Since 2022, sanctions have restricted the import of European and American reference standards (RS). These materials now arrive through alternative channels, raising concerns about their authenticity and storage conditions. This situation underscores the urgent need to develop a domestic RS repository.

NCSS is actively expanding its line of domestic reference standards for quality control of active pharmaceutical ingredients (APIs), impurities, and excipients. Current priorities include developing impurity reference compounds for existing INNs. NCSS's portfolio now comprises approximately 250 reference materials, with plans to expand the range to include substances beyond the Essential Medicines List.

By 2030, Russia aims to capture 70% market share with domestically produced reference standards. Achieving this target will require systematic integration of national reference materials into pharmaceutical manufacturing workflows. Many manufacturers continue using imported reference materials due to either established practices or concerns about modifying registration dossiers. The required regulatory approval process for such changes is perceived as risking significant delays. In some instances, unofficial working standards are employed, adversely affecting product quality. Domestic reference materials are accompanied by comprehensive certificates detailing all critical characteristics required by regulatory experts. Collaborative efforts with the Ministry of Health and Ministry of Industry & Trade are streamlining regulatory frameworks to accelerate adoption. These certified reference materials have already gained recognition in Uzbekistan and Azerbaijan as approved reference standards.

Persisting skepticism toward domestic reference materials stems partly from regulatory ambiguities and practitioners' limited awareness. Documented instances exist of misinterpretations regarding the approved-type reference material status.

We maintain that resolving regulatory inconsistencies and enhancing manufacturer education constitute the critical pathway for transitioning to new standards and reducing reliance on imported solutions.

Monday - Friday
09:00 - 18:00

Saturday - Sunday
Closed

Nagornaya Street, 3a, NPK Krunit Room/Office I/24-34, 36 117186 Moscow, Russia

+7 (495) 909 21 98

+7 (909) 962 00 84

info@ncso.su