Foreign pharmaceutical companies have minimized clinical trials of drugs in Russia
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According to the results of the first half of 2023, foreign pharmaceutical companies received seven permits to conduct clinical trials of new drugs in Russia. About it informed Kommersant with reference to the Association of Clinical Research Organizations (ACTO).
According to the association’s calculations, the Russian company Biocad also received another approval for clinical trials. These figures are 13.5 times less compared to the same period last year, when the Ministry of Health issued 111 such permits (-27.5% by 2021).
According to the newspaper, the only company that received permission to conduct tests at an early stage was the American AbbVie, which applied to the Ministry of Health even before the restrictions. In March 2022, Pfizer, BayerGilead, Novartis, MSD, Sanofi and AbbVie have suspended investments or clinical trials in Russia.
Before bringing medicines to market, companies must conduct trials on Russian patients. Sanofi confirmed that they plan to conduct later phases of the study among those patients who participated in the early phases of the trial. The list of clinical trials says that other pharmaceutical companies have such plans, including Pfizer, MSD and Roche. ACTO noted that the only company that plans to conduct full-fledged tests was the small American Agenus, which did not announce restrictions.
According to ACTO data, the total number of approvals issued for clinical trials by foreign pharmaceutical companies decreased to 340, which is 20% less compared to the first half of 2022. At the same time, the share of generic trials by Russian companies in the structure of approvals issued increased to 67.4%. Since the beginning of the year, 229 permits have been issued, up 33.9% year-on-year.
Among the options by which foreign drugs can enter the Russian market, the interviewed experts name the recognition of the results of international trials abroad or the use of unregistered drugs, said Nikolay Bespalov, RNC Pharma Development Director.
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