The state registration of generic drugs in the form of concentrates for solutions will no longer require a report on bioequivalence studies. A relevant draft law was adopted by the Russian State Duma in the first reading.
Currently, this rule applies to powders and lyophilizates intended for solutions.
“Concentrates for solutions are a new dosage form, which was rarely used in Russia,” said Alexander Petrov, a member of the State Duma Health Protection Committee.
According to Fedot Tumusov, the author of the draft law and the First Deputy Chairman of the State Duma Health Protection Committee, the proposed rule will allow to speed up the registration of generics in the Russian market by 2-3 times.
“It will also allow to produce drugs at a lower price,” said the State Duma deputy.