The NCRS team visited the international CPHI exhibition in Shanghai.
04.07.2025
Another 42 reference materials from NCRS have been recognized in CIS countries.
03.08.2025
Transformation of the Pharmaceutical Industry
The global pharmaceutical industry is in a state of continuous evolution, where key developments in standardization and reference materials (RMs) are shaping the future of the sector. NCRS analyzes worldwide trends to remain at the forefront and maintain the highest quality standards.
5 Key Trends Transforming Standardization and Reference Materials
Harmonization of Regulatory Requirements
Leading global regulators such as the FDA (USA), EMA (Europe) and PMDA (Japan) are actively converging their approaches to GMP (Good Manufacturing Practice), GCP (Good Clinical Practice) and reference materials.
This simplifies international cooperation and increases trust in pharmaceutical products. An important step has been the mutual recognition of inspections, which accelerates drug approval in global markets.
Digital Transformation
The implementation of electronic labeling, online registration systems and unified databases significantly accelerates quality control and reduces error rates. Automated platforms enable faster inspections, verification of drug authenticity, and minimization of mistakes.
Localization of Reference Materials Production
Following the COVID-19 pandemic and global logistics changes, many countries have intensified efforts to develop their own reference materials. The NCRS is actively expanding production of domestic GOST-certified reference materials, reducing import dependence and strengthening Russia's pharmaceutical security.
Implementation of Artificial Intelligence and Advanced Technologies
Machine learning and digital algorithms are increasingly being used to predict substance composition, analyze quality, and optimize standardization processes. This enables faster and more accurate assessment of product compliance with established regulations.
NCRS Leading the Trend: Compliance with Global Standards
These changes are setting a new development vector for the pharmaceutical industry, and NCRS is actively implementing best international practices in its work. The Center continues to develop cooperation with leading regulators, expand its range of domestic reference materials, and implement digital solutions to enhance quality control efficiency.
