![]() ![]() Although at present, when passing this procedure in the Russian Federation, cases of ND request approved in the Russian Federation are known. The ND is part of Module 1 dossier (1.5.7) and is attached to the dossier. Therefore, the information in the ND cannot contradict those in Module 3.Īs you know, by the end of 2025 all drugs registered in the territory of the Russian Federation must undergo the procedure of bringing the dossier in line with the requirements of the EAEU. When drafting the ND, it is important to consider that it is based mainly on the documents of Module 3 of the dossier. 151 “On Approval of the Guidelines for the Preparation of a Normative Document on the Quality of a Drug” 78 “On Rules for Registration and Examination of Medicines for Medical Use” ![]() ND is needed for laboratory examination during the drug registration and is also an instruction for quality assessment for laboratories in the post-registration period (for example, when the drug is brought into civil circulation).Ĭurrently, the requirements for the development of ND are regulated by the following main documents: Further in the body of the ND itself, each analytical technique used to determine a particular measure of quality is described in detail. As mentioned above, the ND includes a specification describing quality indicators, methods for their determination and acceptance criteria. ![]() The definition of the ND contains important information about the composition of this document. Transformation of normative documentation in the ND is accompanied by a more accurate and detailed definition of the term.
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