Формат электронного общего технического документа как основа единого фармацевтического рынка Евразийского экономического союза

Abstract

Background. Due to ratification of the Decision of the EAC Commission on the circulation of medicinal products, a common EAEU pharmaceutical market will be formed, and registration dossiers will be accepted in electronic form of eCTD in XML format starting from January 1, 2021. It is related to the fact that the EAEU member states will exchange information on medicinal products and their results within the framework of an information integrated system. An application for marketing authorization is now submitted in electronic form in PDF format in accordance with the legislation of the Russian Federation. The XML format has been used in the EU since 2003, but not in the Russian Federation. To continue circulation of authorized medicinal products on the territory of the EAEU, it is necessary to bring the registration dossier in accordance with the requirements of the EAEU by December 31, 2025. Beginning on January 01, 2021, applications for marketing authorization of medicinal products will be only accepted under the legislation of the EAEU. In this regard, Russian enterprises - marketing authorization holders have been tasked with converting all registration dossiers to XTML files. The study is aimed to analyse the market for proposals for installation of software to convert documents to the required format and development recommendations for enterprises - marketing authorization (MA) holders - for making the necessary decisions. Commercial proposals of three software companies were studied and recommendations were developed for enterprises - MA holders within the framework of a situation analysis.Purpose of the study. To analyse the market for proposals for installation of software to convert documents to the required format and development recommendations for enterprises - marketing authorization (MA) holders for making the necessary decisions.Conclusion. The study identified factors that have an impact on the decision-making of the heads of pharmaceutical organizations regarding the choice of proposals for installation of software to convert registration dossier documents to the required format according to the rules of the EAEU. It investigated the consequences of various decisions. Recommendations have been developed for companies - MA holders for submitting an electronic DMF in accordance with the EAEU rules.