The clinical research sector in Russia has been growing exponentially over the last decade, largely as a result of increased outsourcing to emerging countries. To facilitate this growth, the Russian government has created several incentives for foreign companies including regulatory reforms.
The Clinical Trial Research in Russia
In 2010, for example, a new drug law was put in place “On the Circulation of Medicines”. The law set a maximum cost and time limit for drug registration and established that drugs manufactured in Russia for export did not need to undergo registration. This was meant to streamline the country’s bureaucratic regulatory system for the testing and registration of new drugs, and as a result boost the domestic pharmaceutical industry and attract more foreign companies to outsource clinical trials to Russia.
Instead, the 2010 law has negatively impacted the country’s clinical research sector. According to a report from the Association of Clinical Trials Organizations (ACTO) which represents companies conducting clinical trials in Russia, the result of the law was that it limited the number of drug approvals and thereby the number of clinical trials conducted in the year 2011.
One reason for the low approval rate is that with this law, new drugs that have already been approved in a country other than Russia must undergo local trials before they can be sold in Russia. This type of testing is considered necessary, for example, in Asia where genetic differences between the tested and target populations may affect drug effectiveness and dosage due to factors related to ethnicity and race. In contrast to Asia, prior testing on American and European populations is comparable to testing in Russia.
Many foreign companies have contracts with government-funded Russian companies to develop new drugs for the Russian market. However, with the 2010 law, any drugs that have been developed outside of Russia cannot undergo preliminary testing in Russia.This has created an additional barrier for many international companies interested in developing products for the Russian market.
Another aspect of the law that has played a role in limiting the number of approvals is related to the drug application itself. According to ACTO, an estimated 30% of clinical trial applications are currently rejected by the Russian Ministry’s Ethics Council, mostly as a result of administrative or clerical errors in the applications. But because Russia’s new medicines law does not allow the Ethics Council to contact companies directly, these types of easily corrected errors cannot be addressed.
We at Language Connections work regularly both with companies outsourcing clinical trials to Russia as well as with Russian government-funded companies investing in biotech firms in the Boston area and abroad. Our team of linguists is composed of native Russian speakers with a background in the life sciences.
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