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The Ministry of Health is confident in the safety of drugs approved under accelerated registration

The approach to drug registration in Russia, including the accelerated one, makes it possible to guarantee their effectiveness and safety, TASS reports with reference to the press service of the Russian Ministry of Health.

Earlier, Kommersant reported that the State Duma would consider a bill prohibiting the use of drugs by children, adolescents and pregnant women that have not passed the full cycle of clinical trials. The author of the initiative, the head of the State Duma Committee on Family, Women and Children, Nina Ostanina, calls the amendment a “social order” for Russian citizens, justifying it by the need to “take children, adolescents and pregnant women out of the scope of the law on immunoprophylaxis in terms of protecting their reproductive health.”

“It should be noted that the mechanisms of accelerated registration (registration on conditions) are used by regulatory authorities around the world. The regulatory framework for the registration of medicines, including the approach to assessing the efficacy and safety of medicines, assessing their quality, coincides with the requirements established by the regulatory agencies of other countries, including the European Union and the United States. Most vaccines in the US and EU are registered under the emergency procedure. The approach to drug registration in Russia makes it possible to guarantee the therapeutic efficacy, quality and safety of original and generic drugs, provides the necessary resources for access to innovative drugs, including domestic ones,” the Ministry of Health said.

The ministry also explained that the accelerated registration of medicines for the treatment of coronavirus infection is carried out to ensure patients' access to the necessary medicines.

“The decision of the Government of the Russian Federation to create such a mechanism made it possible to quickly allow drugs and vaccines to be used without compromise on quality and safety and save hundreds of thousands of lives of Russians,” the department noted.

They added that at the same time, such drugs are registered only on the basis of positive results of the clinical trial program and subject to the introduction of post-registration measures, including restrictions on the use of drugs, the appointment of conducting clinical trials in full in the post-registration period, special conditions for monitoring the safety of the use of such medicines.

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