At its plenary session held on January 19, the deputies of the State Duma adopted at the first reading the draft law “On Amendments to the Federal law “On circulation of medicines.”
The explanatory note to this document indicates that the amendments proposed to the draft law will allow to speed up time to the Russian market for medicines and will contribute to developing the contract manufacturing of drugs in Russia. The contract manufacturing of medicinal products will encourage competition in the Russian pharmaceutical market and create conditions required for increasing the exports of Russian-made medicines.
Sergey Tsyb, the Deputy Minister of Industry and Trade of the Russian Federation, said that, if the manufacturers producing the drugs outside Russia have no document confirming their compliance with the requirements and rules of good manufacturing practice, the draft law allows them to submit a copy of the decision made by the authorized federal body of executive power on inspection of the foreign manufacturer.
According to Sergey Tsyb, the law will simplify the procedure for state registration of medicines, while ensuring their quality and safety.
The possibility of registering the drugs manufactured on the same site and having the same international non-proprietary name but different trade names will reduce the burden on manufacturers, speed up time to the Russian market for new medicines, and increase the competition.