The Russian government has ordered preparations for changes to the rules for registration of drugs in the Russian pharmaceutical market – in a move aimed to speed the launch of the drugs by three to five years, according to recent statements by an official spokesman of the government and some local media reports.
As part of these plans, a fast track regime will be introduced that will allow bringing innovative drugs to the market already on the basis of Phase II clinical trials, reports The Pharma Letter’s local correspondent. In this case, the drug will receive a temporary registration certificate that, however, will be limited by certain conditions
The government hopes the introduction of such changes will improve access for the local population to innovative drugs and contribute to a significant increase the share of domestic drugs in the market.
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