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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In the spring of 2022, in connection with the introduction of economic restrictive measures against the Russian Federation, the Government of the Russian Federation issued Resolutions regarding the specifics of the circulation of drugs in the event of a inventory shortage or the risk of a inventory shortage (No. 593), as well as on the specifics of introducing changes to
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At the end of March 2022, Decision No. 36 of the EEC Council came into force, which introduced some adjustments to the existing drug registration system (Decision No. 78). For example, the following “types” of marketing authorization became possible: registration of drugs with post-registration obligations, registration of drugs in exceptional cases, conditional registration of drugs, accelerated registration of drugs. In
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In the previous article, we reviewed new registration procedures specific to certain drugs in accordance with the requirements of the EAEU. Currently, a drug be approved in the frame of approval procedure with post-registration obligations and in exceptional cases. In addition, Decision 36 also introduces conditional and accelerated registration, which will be discussed in this article. 1. Conditional registration (Section
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With the entry into force of the EAEU registration rules, the classification of drugs has changed significantly, as we wrote in the article “NOMENCLATURE OF MEDICINES WITHIN THE FRAMEWORK OF REGISTRATION ACCORDING TO THE RULES OF THE EAEU”. (https://beawire.com/ru/2020/09/16/nomenclature-of-medicines-within-the-framework-of-registration-according-to-the-rules-of-the-eaeu/). However, the existing classification does not quite clearly describe such category of drugs as FDC-FPP. It is worth noting that its
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In early October, the State Register of Medicines (GRLS) revealed the suspension of a number of ranitidine drugs intended to treat peptic ulcer disease. The reason for the mass suspension was the conclusion of FSBI «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation which was based on information on the presence
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Humanity now uses a huge number of biotech drugs without thinking about their origin and production process. Such drugs include, for example, insulin, hormonal drugs, vaccines, etc. Biotechnology (BT) drugs account for 29% of sales in Russia. BT drugs are expected to account for 35% by 2026. What does a “biotech” drug mean? What is its difference from “chemical” and
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