Category Archives: Drugs

What is a Pharmacopoeia and why is it needed?

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?

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?

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?

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?

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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Inventory shortage or risk of inventory shortage – update of legislation. Part 1.

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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New types of drug registration under the requirements of the EAEU.

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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Conditional and accelerated registration of drugs

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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Fixed-dose combination finished pharmaceutical product (FDC-FPP)

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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