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Russia to allow imported drugs that have not undergone clinical trials in the country

25 October 2018

Remedium

The Russian government plans to provide access to imported drugs that have not undergone clinical trials within Russia, according to recent statements by some senior officials of the Russian Ministry of Health, reports The Pharma Letter's local correspondent.

This will apply to drugs from countries of the European Union, as well as the USA and Japan and will be part of the existing roadmap "Development of Competition in Public Health," which has been recently approved by the Russian government, The Pharma Letter’s local correspondent reports.

A spokesman for Russian Minister of Health Veronika Skvortsova said this measure will provide domestic patients with better access to new drugs.

It is planned that such drugs will be labeled with a warning that the drug has not undergone clinical research in the Russian Federation.

Currently, the launch of a new drug into the Russian market takes up to five years, of which up to three years is taken up by domestic clinical trials. However, this situation is expected to change shortly.

Planned liberalization will not affect all the new drugs supplied to the Russian market, but primarily those the production of which analogues has not established in the country. It is planned that final principles of drug selection should be worked out by the end of the current year.

Currently the list of the most demanded drugs among Russian patients includes anti-cancer drug and drugs against epilepsy, as well as orphan drugs for the treatment of rare diseases.

According to the Ministry of Health, implementation of the new initiative will be started by the end of the current year.

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