Russia to speed registration of drugs not localized in domestic market

The Russian Ministry of Health wants to speed registration of drugs that are not localized in the Russian Federation at the time of the application submitted by domestic pharmaceutical companies, explaining such changes by "unpredictable geopolitical situation," reports The Pharma Letter’s local correspondent.

According to an official spokesman of the Ministry, "taking into account the unpredictable geopolitical situation," accelerated registration of drugs that are not produced in the Russian Federation will be possible regardless of the current supply and balances of drugs in hospitals and pharmacies, as well as the volumes of their production.

In accordance with the current Russian legislation, drug registration in the case of a shortage or its risks should take no more than 60 working days from the date of submission of documents to the Ministry of Health. According to the ministry's latest draft, for drugs not localized in the country, these periods will not exceed 100 days from the date of submission of documents.