News

Infarma, an association of pharmaceutical companies that comprises major international and Russian drug manufacturers, has sent a letter to the director of the U.S. Food and Drug Administration's (FDA) Centre for Drug Evaluation and Research (CDER) requesting that the results of clinical trials conducted in Russia be incorporated in its global review. This was reported by Kommersant newspaper, citing the association's letter. In addition, the association suggests that the FDA could conduct inspections of Russian research centres directly on site or in an online format.

International pharmaceutical companies suspended trials of new drugs in Russia after the military operation in Ukraine started in 2022, although no sectoral sanctions have been placed on the Russian pharmaceutical industry. As a result, according to Infarma, while more than 300 clinical trials were conducted in Russia in 2021, only 24 took place in 2024. The Russian market's response was the compulsory licensing of original drugs which foreign manufacturers cannot put into circulation in Russia without conducting clinical trials in the country.

Many Western pharmaceutical companies (with the exception of U.S. companies Eli Lilly and Bristol-Myers Squibb) continue to supply their drugs to the Russian market, Kommersant says. However, the reduced number of clinical trials runs the risk of foreign companies losing their share of the Russian market, since by law a drug cannot be registered in the country without local trials. Many Infarma members are thinking of resuming trials in Russia, Kommersant says, citing the association's executive director Vadim Kukava.

Infarma comprises 19 foreign pharmaceutical companies operating in Russia, including Amgen (USA), AstraZeneca (UK), Bayer (Germany), Jonhson & Johnson (USA), and Novartis (Switzerland). However, not all members of the association supported sending the letter to the FDA, Kommersant reports.