Author Archives: beawireA

Pre-Submission Process for IVDs.

A Pre-Submission includes a formal written request from a submitter for feedback from the FDA which is provided in the form of a formal written response or, if the submitter chooses, a meeting or teleconference in which the feedback is documented in meeting minutes. A Pre-Submission meeting is a meeting or teleconference in which the FDA provides its substantive feedback

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IVD regulatory approval process in European Union.

Approaches to the regulation of in vitro diagnostic (IVD) medical devices vary by country. For example, in the United States, there is no separate classification for IVD devices, and a general regulatory system developed for medical devices is applied. If we talk about the European Union (EU), then the approach is different. For IVD products, a separate classification and a

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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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Fluorescence in situ hybridization – FISH test

In Russia, there is a risk of disappearance of tests for genetic breakdowns and oncological diseases. According to information from some laboratories, there is a risk of stopping the so-called FISH studies. It can happen because the American manufacturer of equipment, reagents, consumables, and software Thermo Fisher Scientific left the country. Fluorescence in situ hybridization (FISH) is a molecular cytogenetics

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Trademark registration in TROIS

TROIS is the Customs Registry of Intellectual Property Rights[1]. As of 2020, pursuant to the decision of the Supreme Court, trademarks are entered in TROIS upon application from the applicant, rather than upon discovering an infringement of intellectual property rights during the import of counterfeit goods, as has been the case since the creation of this register in 2004. TROIS

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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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Changes in Government fees during custom clearance of medical device samples

With reference to the current economic situation, in April two resolutions of the Council of the Eurasian Economic Commission were adopted, namely No. 46 dated 5 April 2022 and No. 63 dated 12 April 2022, which changed the import duty rates for a particular group of goods. Pursuant to the above-mentioned resolutions, upon import of goods from the list an

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Registration of medical devices in Tajikistan.

Currently, the pharmaceutical sector is one of the priorities for development in Tajikistan. In 2020, the government of Tajikistan issued a resolution “On the State Program for the Development of the Pharmaceutical Industry in the Republic of Tajikistan for 2021-2025”.  One of the objectives of the Program is to improve the legal framework of the Republic of Tajikistan in the

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