If a drug is already registered abroad, the need for conducting phase III clinical trials may be exempted. During a discussion at the Federation Council, Andrey Kaprin – the General Director of the National Medical Research Center for Radiology and Chief Non-Staff Specialist Oncologist of the Ministry of Health of Russia – shared his expert insight.
“For instance, individuals suffering from synovitis often rely on NSAIDs (non-steroidal anti-inflammatory drugs) for prolonged periods of time. Effectively alleviate joint pain. The drug is already ready, but it also requires a third phase”, he said. According to him, the Ministry of Health is not authorized to finance the third phase; it can only fund the first and second ones through the state order.
He also added that the third stage of the research is focused on commercialization. While the trial takes three to four years to complete, the drug could be administered during this period, potentially benefiting patients.
The availability of drugs for cancer patients was reported to be unaffected by any issues, according to the Russian Association of Oncologists in May. Andrey Kaprin emphasized that many drugs have been replaced by their generic counterparts, which may differ in some aspects.
