According to RBC, the US pharmaceutical company Pfizer uses alternative drug registration mechanisms provided for by the rules of the Eurasian Economic Union (EAEU). Nikita Ivanov, head of Pfizer’s Russian division, told the publication.
We are talking about several regulatory routes that allow obtaining a registration certificate without conducting new trials directly in Russia. One of them is the procedure of mutual recognition of registrations within the EAEU, when a drug first receives approval in one of the countries of the union and then can be registered in other markets of the association.
Another tool is the so-called GCP inspections. Under this mechanism, regulators of the EAEU countries can conduct unscheduled inspections of foreign research centers to confirm the quality and reliability of clinical trials already conducted. This approach actually opens the way to the registration of innovative medicines without the need to repeat trials on Russian territory.
After the start of the conflict in Ukraine, most Western manufacturers curtailed new investments in the Russian market and stopped launching new clinical programs. As a result, the traditional mechanism of launching innovative medicines was significantly limited.
However, the regulatory system has gradually adapted to the new conditions. Over the past two years, the EAEU has expanded opportunities for mutual recognition of registrations and use of foreign trial data, while the Russian authorities have simultaneously extended simplified procedures for registration of medicines to ensure stability of supplies to the domestic market.
According to the source, Pfizer has no plans to announce new clinical trials in Russia. Nevertheless, the company intends to continue withdrawing drugs through available regulatory mechanisms.
In fact, this means that even in the conditions of geopolitical restrictions, international pharmaceutical companies retain the ability to launch new drugs on the Russian market. Although this process now follows a much more complex and multi-stage scheme than before 2022.
