In 2022, the Government of the Russian Federation developed a number of regulations regarding the circulation of medicines for medical use in the event of inventory shortage or risk of inventory shortage of medicinal products (Orders No. 593, PP No. 440, Order No. 339n). On February 13, 2023, Order No. 724n “On Amendments to the Regulations on the Interdepartmental Commission
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Hemophilia B is an inherited disease that results in a malfunction of the gene that regulates the synthesis of blood coagulation factor IX. As a result, patients suffer from bleeding, which is very difficult to stop. With hemophilia, the risk of death of a patient from a hemorrhage in the brain and other vital organs increases sharply, even with a
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One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure. As part of this procedure, a dossier must be submitted to the FDA, consisting of two parts – administrative and technical. This article will consider the documents included in the dossier. The dossier itself is called “Premarket approval application”. The applicant
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On August 18, 2022, Rospotrebnadzor sued the founder of the Wildberries marketplace, Tatyana Bakalchuk. The reason for going to court was improper control over the dosage of vitamin D sold on the marketplace, the excessive use of which can be dangerous for humans. In this regard, Rospotrebnadzor demanded that the entire section with vitamins and nutritional supplements be closed. In
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In the previous articles under the heading of regulation of the medical device market, we looked at how the registration procedure in the United States looks like in general, and also paid attention to the classification of medical devices and the pre-market notification procedure. This article will focus on devices of the third risk class, in particular, the premarket approval
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In 2022, the so-called “accelerated” registration procedure for medicines for which there is a risk of inventory shortage was organized in Russia (read more about this phenomenon in previous articles). In December 2022, the first marketing authorization (MA) was obtained in the frame of this procedure. The Ministry of Health of Russia approved the antitumor drug Pembroria (international non-proprietary name
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In December 2022, it became known about deaths among children in neighboring countries associated with taking an Indian drug in the form of cough syrup called Doc-1 Max. Ethylene glycol was found in one of the series of this drug. What is this substance and what is its danger? Ethylene glycol is a vicinal (containing two OH groups) diol. The
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On December 22, 2022, Regulation of the Government of the Russian Federation No. 2374 dated December 22, 2022 “On amendments to the list of medical devices, the sale of which in the Russian Federation and import into the Russian Federation and other territories under its jurisdiction, are not subject to taxation (exempted from taxation) with value added tax”, which will
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According to the register of medicines in the Russian Federation, there are 218 drugs containing paracetamol as an active pharmaceutical ingredient. Paracetamol is widely used as an antipyretic and pain reliever among adults and children. The chemical-pharmaceutical synthesis of paracetamol is carried out from 4-aminophenol, the content of which is normalized in all drugs based on paracetamol. What for? 4-aminophenol
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On June 23, 2022, an innovative HIV drug called Sunlenca (lenacapavir) manufactured by the American company Gilead was approved in Europe. The drug has been approved under a centralized procedure in all 27 EU member states, including Norway, Iceland and Liechtenstein. The regulators made their decision based on a phase II/III study called CAPELLA. In the trial, 83 % of
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