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Рычихина Е.М.
Preparation of Module 1 of the Registration Dossier According to the EAEU Procedure
Scientific Centre for Expert Evaluation of Medicinal Products, 8/2 Petrovsky Blvd, Moscow 127051, Russian Federation
Ekaterina M. Rychikhina; richikhina@expmed. ru
Abstract
The legislation of the Eurasian Economic Union (EAEU) includes all the necessary requirements and tools to implement a unified approach to preparing Module 1 of the electronic Common Technical Document (eCTD) for the concerned member states (CMSs). However, the approaches to the matter and the recommendations provided to applicants differ across member states. This causes significant ambiguity and imposes an excessive burden on the applicants. Drafting of a guideline on preparation of eCTD Module 1 for the CMSs will allow for tackling this important grey area in the EAEU regulatory framework, as regulatory authorities are lacking consensus on country-specific submissions. Currently, pharmaceutical industry stakeholders consider the Russian experience of implementing the legis¬lation in question the most successful, so it is proposed to convey this experience to the common market of the EAEU.
© Е.М. Рычихина, 2022
Key words: registration dossier; Module 1; medicines; concerned member state; country-specific documents
For citation: Rychikhina E.M. Preparation of Module 1 of the registration dossier according to the EAEU Procedure. Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo primeneniya. Regulyatornye issledovaniya i ekspertiza lekarstvennykh sredstv = Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Re¬search and Medicine Evaluation. 2022;12(3):341-347. https://doi.org/10.30895/1991-2919-2022-12-467
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