National Center for Certified Reference Materials and Acticomp have agreed to collaborate
Domestic manufacturer of active pharmaceutical ingredients (APIs), the company Active Component, has announced the start of cooperation with the National Center for Certified Reference Materials in the direction of developing, testing and producing reference materials (standard samples) in the pharmaceutical and medical industry, namely, the State Certified Reference Materials (GSO) (Approved standard samples) on the territory of the Russian Federation and the EAEU.
The fact that the Russian Federation needs its own bank of reference materials and the production of domestic active pharmaceutical ingredients (APIs) has been discussed for several years, but only the situation with the import of APIs that developed owing to the pandemic could demonstrate the significant dependence on foreign manufacturers and suppliers.
Alexander Semenov, President of Acticomp was quoted as saying:
"The use of various reference materials is regulated by law not only in quality control and examination, but also in many other processes at all stages of the life cycle of any drug, including at the development stage. Unfortunately, for a long time this problem was not covered at a sufficiently advanced level, and domestic manufacturers were forced to use imported products, namely pharmacopoeial reference materials of foreign pharmacopoeias and reference materials of private foreign manufacturers which could not be tested in accordance with the Federal Law "On ensuring unity of measurements" dated 26.06.2008
No. 102-FZ. The current situation made domestic producers directly dependent on foreign producers and supplies»."
The establishment of NCCRM LLC (National Center for Certified Reference Materials LLC) was preceded by a long process of preparation, studying the experience of creating State Certified Reference Materials by other countries, making changes to regulatory documents and the inclusion of the State Institute of Drugs and Good Practices in various working groups. In addition, the State Institute of Drugs and Good Practices became a full member of the State Service of Certified Reference Materials and comprehensively prepared for the implementation of the large-scale project. As a result, on February 28, 2020, a subsidiary of the State Institute of Drugs and Good Practices under the Ministry of Industry and Trade of the Russian Federation was established – the National Center for Certified Reference Materials LLC whose main activity is the development, production and supply of state certified reference materials and standard samples.
"Our cooperation in the field of reference materials with NCCRM LLC not only has commercial goals, i.e. to reduce the cost of purchasing foreign reference materials and provide, with the help of NCCRM LLC, prompt access for end users to reference materials, but also political ones in terms of implementing the import substitution program and the establishment of Russian reference materials as standards on the territory of the EAEU, as well as the near and far abroad. It is worth noting that within the framework of cooperation, the first objectives have been achieved: by order of Rosstandart, 3 types of State Certified Reference Materials under the NCCRM have been established and approved on the territory of the Russian Federation, which will allow us and our colleagues to make large-scale plans for next year," said Alexander Semenov.
The National Center for Certified Reference Materials LLC (NCCRM LLC)
On February 28, 2020 the State Institute of Drugs and Good Practices, in order to implement the functions of a participant, as part of the State Service of Certified Reference Materials, created the subsidiary company – National Center for Certified Reference Materials LLC. 100% of authorized capital belongs to the State Institute of Drugs and Good Practices. The establishment of the National Center for Certified Reference Materials is associated with the need to organize the development and implementation of reference materials of active pharmaceutical ingredients, impurities, intermediates, excipients and other chemical compounds in the pharmaceutical industry, both included and not included in the State Pharmacopoeia of the Russian Federation and the Pharmacopoeia of the Eurasian Economic Union within the competence of the institution as the designated controller appointed by the State Service of Certified Reference Materials. Furthermore, in order to fulfill the functions of the designated organization (appointed by the State Service of Certified Reference Materials) for the development of measures aimed at providing the industry with reference materials of all categories, providing information to the institution on whether an organization needs (number and name) reference materials or not is carried out on a voluntarily basis in terms of the organization's business activities and interest in reference materials.