The approach to medicines registration in Russia, including emergency authorization, allows us to guarantee their effectiveness and safety, TASS reports with reference to the press service of the Ministry of Health of Russia.
Earlier, Kommersant reported that the State Duma will consider a bill according to which drugs that have not passed a full cycle of clinical trials must not be administered to children, adolescents, and pregnant women. The author of the initiative, Nina Ostanina, who is the head of the State Duma Committee on Family, Women and Children, calls the amendment a “social order” given by Russian citizens, justifying the need to “exclude children, adolescents and pregnant women (in order to protect their reproductive health) from the scope of the law on immunoprophylaxis.”
“It should be noted that the mechanisms of accelerated registration (conditional registration) are used by regulatory authorities all over the world. The regulatory framework for the registration of medicines, including the approach to evaluating the effectiveness and safety of medicines, and the assessment of their quality coincides with the requirements established by regulatory agencies of other countries, including the European Union and the United States. It is the emergency use authorization that most vaccines in the US and the EU receive. The approach to registration of medicines in Russia guarantees the therapeutic efficacy, quality and safety of original medicines and generics, ensures the necessary resources for access to innovative medicines, including their domestic production,” the Ministry of Health reported.
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 allow drugs and vaccines to be used within a short time without compromising their quality and safety, thus saving hundreds of thousands of lives of Russian citizens,” the ministry noted.
They added that such drugs are registered only on the basis of positive results of clinical trials program and subject to the introduction of post-registration measures, including restrictions on the use of the drugs, instruction on holding clinical trials in full in the post-registration period, and special conditions for monitoring the safety of such drugs.