The Russian Parliament (State Duma) plans to ease access to innovative and orphan drugs to the Russian market through the introduction of amendments to the existing federal law “On Circulation of Drugs” in Russia.
Officials believe that this is an urgent need, as pharmaceutical manufacturers have long been complaining about the length and complexity of the procedures for registration of new drugs in Russia, which is currently 210 working days and which, according to drugmakers, slows down their appearance in local pharmacies and hospitals.
Until now, the government did not have any plans to introduce any changes in the existing procedure. However, there is a possibility that the current registration scheme might be changed in the case of innovative and orphan drugs.
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