The Metrology Service of the Ministry of Health of Russia

The Metrology Service of the Ministry of Health of Russia was established in accordance with Order No. 202 of the Ministry of Health of Russia dated 20 March 2020, and is functioning under the aegis of SCEEMP. The Metrology Service is responsible for metrological support in the area of regulation of medicinal products for human use.

The composition of the Metrology Service of the Ministry of Health of Russia was approved by Order No. 127 of the Ministry of Health of Russia dated 1 March 2022. The Metrology Service of the Ministry of Health of Russia is headed by Valentina Kosenko, General Director of SCEEMP.

The metrological support system for medicinal products regulation has been created and operates for the following purposes:

• providing regulatory, organisational and technical support to ensure uniformity and required accuracy of measurements in the area of regulation of medicinal products for human use;
• achieving the required accuracy of measurements, validity and consistency of test results during establishment and fulfilment of requirements for pharmacopoeial reference standards, reference standards for medicinal products for human use, working reference standards for medicinal products for human use, development of pharmacopoeial reference standards for quality control of investigational medicinal products, as well as development of pharmacopoeial monographs and general chapters in accordance with the federal legislation;
• providing an evidence base for quality control and conformity assessment of investigational medicinal products;
• obtaining valid results for tested characteristics/parameters when implementing quality control of investigational medicinal products;
• advancing the technical maturity of measuring equipment and measurement processes employed by organisations, introducing modern measuring tools and methods, automated measuring equipment, data-measuring systems;
• determining the main areas of activity for metrological support of scientific research, engineering, production, and disposal of products, and other areas of activity in the field of regulation of medicines for human use;
• organising production and establishment of pharmacopoeial reference standards;
• forming a regulatory framework to ensure the uniformity and required accuracy of measurements in the field of regulation of medicines for human use.

Important milestones

Document Library