The Russian Government Has Approved a Simplified Procedure for Drug Registration

The Russian Government Has Approved a Simplified Procedure for Drug Registration
Photo: Roberto Sorin / Unsplash 12.04.2022 142

Simplified registration of medicines, according to state authorities, will allow to avoid shortages.

The Decree on simplified registration of medicines was signed by the Head of the Government Mikhail Mishustin. The decision will be valid until the end of 2023.

Now the Ministry of Health will be able to conduct accelerated registration of drugs, therapeutic analogues of which may be in short supply on the Russian market in conditions of sanctions. It is not only about generics of original drugs, but also about drugs, the substitutability of which will be separately established by the interdepartmental commission.

According to "Kommersant" newspaper, the accelerated registration will allow drug manufacturers to avoid clinical trials in the Russian Federation which are usually necessary for their introduction to the market.

"We are taking measures to ensure that the necessary drugs are available. It is clear that so far our own production has not been set up for some items or not enough products are produced. We still import some of them from abroad. It was decided to speed up and simplify the procedures for state registration of medicines that are in short supply in our country,"

noted Mishustin.

Many Russian drug manufacturing companies use ready-made imported substances and dosage forms, the supply of which in the face of sanctions has been significantly reduced. And some major international pharmaceutical companies said that they refuse to conduct new clinical trials in Russia. Previously, clinical trials in Russia were a prerequisite for registration of medicines in the country. 

Source: Kommersant,

pharmaceutical markets  Russia 

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