Page 143 - RusRPTOct22

for research within 48 hours. Without clinical trials, registration of most drugs in Russia is impossible, and unregistered mass drugs are closed to state-paid medical care programs.
The 300 unavailable drugs will inevitably include "breakthrough therapies" for diseases now considered incurable, including certain forms of cancer, the authors of the study write.
Theoretically, the government could abolish mandatory local clinical trials for registration of drugs and allow the importation of drugs without labeling and in foreign packaging. In practice, this does not always help even drugs for the treatment of rare (orphan) diseases, local clinical use.
The suspension of clinical trials in Russia by global pharma majors amid the military invasion of Ukraine will send the local pharma market back in time in terms of access to next-generation drugs, Kommersant daily reported citing a study by the Sechenov First State Moscow Medical University.
As followed by bne IntelliNews, a number of global drug manufacturers, including Janssen, Novartis and Pfizer, have suspended new clinical trials in Russia.
In particular, next-generation treatment of cancer, as well as advancements in multi-specific biologics, gene therapy and other breakthrough fields, could become unavailable in Russia.
In July-August 2022 Russia issued 97 approvals for clinical trials, down 24% lower year on year, out of which foreign companies accounted for about 17.5% versus 51% for the same period of 2021.
Russian pharma producers have no analogues to international technologies, market participants told Kommersant, noting that depending on the specific field, import substitution for pharma and biotech could take from three to ten years, with no guaranteed success.
143 RUSSIA Country Report October 2022 www.intellinews.com