The importance of reference samples in the development of pharmaceutical industry was discussed during the meeting of the Healthcare Commission of the General Council of the UNITED RUSSIA Party

The meeting of the Healthcare Commission on “Government regulation of medicinal products marketing. National system of reference samples of medicinal products” held on September 26, 2024 was chaired by Denis Nikolaevich Protsenko, Chairman, Healthcare Commission of the General Council of the Party, member of the Party Supreme Council, Director of the State Budgetary Healthcare Institution “Moscow Multi-Specialty Clinical Center “Kommunarka” of Moscow Healthcare Department”. The event was attended by heads of sector-specific ministries, competent organizations, representatives of the professional associations.

In her speech, Ekaterina Gennadyevna Priezzheva, Deputy Minister of Industry and Trade of the Russian Federation, noted the critical importance of reference samples during release quality control of manufactured medicinal products and emphasized that due to the sanctions one of the mechanisms for supporting drug manufacturers is the expansion and simplification of potential use of domestic reference samples.

In accordance with the Strategy for the Development of the Pharmaceutical Industry until 2030, approved by the Russian Government on June 7, 2023 (Order No. 1495-r), and for the purposes of import substitution of reference samples, a grant support program on the development of reference samples of medicinal products has been launched since 2022. Due to the implementation of import substitution policy, by September 2024, the manufacturers produced and released 767 items of domestic reference samples.

Vladislav Nikolaevich Shestakov, Director of the Federal State Budgetary Institution “State Institute of Drugs and Good Practices” of the Ministry of Industry and Trade of Russia, drew the meeting attendees’ attention to the fact that, currently, the manufacturers do not use the transparency and traceability system during use of reference samples, which may allow some of them to use internal working samples either for running routine and release quality control. In addition, he proposed to look into the opportunity of launching labeling rules for the reference samples, which will fully comply with the national security strategy on production of medicinal products. The meeting attendees supported the need to strengthen the measures for the domestic market protection against potential imports of reference samples, as well as the need to address the benefits of using domestic reference samples, if available, instead of the foreign ones, and subsequent formalization of the current legislation.