Tag Archives: Drugs

The first registration certificate for a medicinal product was obtained under an accelerated procedure.

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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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4-aminophenol in drugs and not only: in what way it is dangerous?

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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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New HIV drug approved in Europe.

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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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What is a Pharmacopoeia and why is it needed?

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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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Will there be a shortage of excipients for the production of drugs?

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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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What is CEP for active pharmaceutical ingredient?

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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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IFU, PL, SmPC – what is it about?

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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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What does “expansion of geography” mean when registering a drug according to the requirements of the EAEU?

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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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