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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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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Recently, the Order of the Ministry of Health of the Russian Federation No. 685p of October 21, 2022 “On Amendments to Certain Orders of the Ministry of Health of the Russian Federation on the Approval of General Pharmacopoeia Articles and Pharmacopoeia Articles” was published, according to which the transition period to the State Pharmacopoeia (SP) XIV is extended until January
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A drug is a complex multicomponent system that consists not only of the active substance (active pharmaceutical ingredient, API) responsible for the effect of the drug, but also of excipients that perform various secondary functions. They are no less important, because thanks to them, for example, a sufficient tablet size, the necessary taste of the syrup, and the optimal consistency
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It’s not a secret that the composition of the drug includes two components: the active pharmaceutical ingredient (API) and excipients. To register a medicinal product with the regulatory authorities, it is necessary to provide a sufficiently large amount of information regarding the quality of the pharmaceutical substance, including a copy of Certificates of Suitability to the Monographs of the European
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Abbreviations from the title of the article are an integral part of the drug dossier. For a common man, such concepts as “instruction for medical use (IFU)”, “leaflet (PL)” and “summary of product characteristics (SmPC)” are synonymous. However, for the regulatory affairs specialist, there is a significant difference between these concepts. In order to understand the difference between IFU, PL
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With the entry into force of the EAEU legislation on the registration of medicines, a whole range of new terms appeared, the understanding of which is key in determining the circulation strategy of the drug in the EAEU member states. One such term is “expansion of geography”. Expansion of geography — registration of the drug in the EAEU member states,
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In the second part of the article on inventory shortage, we would like to pay more attention to registration aspects in the event of a inventory shortage. In the event of a inventory shortage, the state registration of the medicinal product is carried out by the Ministry of Health of Russia within a period not exceeding 60 working days. Documents
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