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This article covers procedures for transitioning to the common market of the Eurasian Economic Union (EAEU), with a focus on low-margin yet high-demand medicines, including herbal medicinal products. First, the article analyses applicant engagement in aligning the dossiers for nationally authorised medicinal products with the requirements of the EAEU authorisation procedures. Then, the article describes the legislative changes introduced to ease authorisation requirements. Finally, the author provides recommendations for applicants.

Scientific relevance. The gradual transition to the common pharmaceutical market within the Eurasian Economic Union (EAEU) is expected to be completed by the end of 2025, and a new regulatory framework is currently being developed at both the national and supranational levels. The main changes in Russian national legislation are aimed to harmonise it with EAEU legislation. However, Russian national legislation will continue regulating a range of issues related to the life cycle of medicines.Aim. This study aimed to compare the Russian and EAEU legal frameworks regulating medicines before and after January 2026, as well as to analyse the risks of conflicts of laws between these legal systems.Discussion. Analysing the causes of potential conflicts of laws between Russian and EAEU legislation, the authors consider solutions for such conflicts outlined in the legal system of the Russian Federation, as well as the applicability of these solutions to specific situations in the national and supranational regulation of medicines. This study analyses the stages in the life cycle of medicines associated with the highest risk of conflicts of laws, including clinical trials, the development of pharmacopoeial requirements, and the designation of orphan medicines. The authors examine the relationships between authorisation procedures during the transition period with both legal systems in effect. The analysis highlights the issues that will continue to be regulated under Russian national legislation after the completion of the transition period, such as the inclusion of active substances in the Russian State Register of Medicines, the authorisation of medicines during armed conflicts or other emergencies, and the interchangeability of medicines. Given the evolving requirements of the regulatory environment, this study provides suggestions for enhancing the regulatory framework and recommendations for applicants.Conclusions. After the complete transition to the common market in the EAEU, certain requirements of Russian Federal Law No. 61-FZ “On Circulation of Medicines” of 12 April 2010 will remain effective in the Russian Federation. Therefore, during the transition period, applicants for authorisation should consider the partial continuation of national regulation after 2026 when developing their regulatory affairs strategies.

Since 2021, the marketing authorisation (MA) of new medicinal products in the Russian Federation has been carried out according to the Rules of Marketing Authorisation and Assessment of Medicinal Products for Human Use that are implemented by Decision No. 78 of the Council of the Eurasian Economic Commission dated 3 November 2016. The Member States of the Eurasian Economic Union (EAEU) must fully transition to the new regulatory framework by 31 December 2025. Therefore, MA holders are required to bring their existing product dossiers into compliance with EAEU requirements and continue submitting new product applications and dossier variations. Under the circumstances, the burden on regulatory authorities has increased significantly, regulatory mechanisms have become more complicated, and applicants have faced the challenge of swift adaptation to the latest requirements. To contribute towards the success of regulatory submissions, this article covers the sequence of regulatory procedures, the scope of work, and recommendations on dividing the procedures into stages, optimising each stage, determining goals and priorities, and assessing timelines and possible risks. To make the approval process more efficient, the authors illustrate the application of different procedures throughout a typical lifecycle of a dossier.

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 legislation in question the most successful, so it is proposed to convey this experience to the common market of the EAEU.

The economic sanctions imposed on the Russian Federation in 2022 create a potential risk of shortages or absence of a range of medicines demanded by the Russian healthcare system. The article describes the legislative measures by the Russian Government aimed at prevention of inventory shortages of medicinal products and, in particular, the special requirements to expert evaluation and registration of the medicines that could be affected by the risk. The article pays special attention to the time frames of assessment and registration procedures.

Vaccines by different manufacturers are available for most of the vaccine-preventable infections covered by the National Immunisation Schedule of the Russian Federation. Determination of the possibility of replacing a vaccine in the case of routine or emergency vaccination still remains a challenging issue. The aim of the study was to substantiate the problem of vaccine interchangeability, outline specific challenges and ways of solving them, analyse criteria underlying evaluation of vaccine interchangeability in Russia, and international experience in this area. The procedure for determining the interchangeability of biological products, including vaccines, was established in the Decree of the Government of the Russian Federation of 5 September 2020, No. 1360 “On the procedure for determination of interchangeability of medicinal products for human use”. The paper analyses the applicability of the official criteria for interchangeability of biological products, including vaccines. It outlines the main problems of performing evaluation of vaccine interchangeability in accordance with the established criteria. It is concluded that the vaccine interchangeability criteria need to be clarified in order to allow for assessment of comparability of active substances, and comparison of efficacy, safety, and immunogenicity of vaccines, taking into account vaccination schedules for different age groups. The possibility of evaluating interchangeability based on the results of post-authorisation studies also needs clarification. It is also necessary to align patient information leaflets for interchangeable vaccines.

The article dwells upon the development and implementation of a computerised information system for automation of expert work related to evaluation of medicines interchangeability parameters. The article analyses the results of application of a process-oriented approach to the development and implementation of an interchangeability evaluation algorithm in an expert institution. The article suggests step-by-step solutions for the development of an information system that will make it possible to automate standard operating procedures and help substantiate expert conclusions. The article provides basic legal and regulatory as well as scientific and technological information necessary for the creation of an information systems project for the development of a single intranet environment of an expert institution ensuring the automation of all key technological processes that rest upon single systematic approaches and principles. It was demonstrated that introduction of the designed information system in the institution ensures efficient implementation of standard operating procedures when assessing medicines interchangeability.

The article analyses international experience of information technology use in pharmaceutical data management. It investigates the possibility of using CALS/PLM-technologies for IT-based management of pharmacy-related activities as exemplified by the introduction of the eCTD format of the registration dossier. The authors provide recommendations that could facilitate the Russian regulatory system’s transition to a similar format and help use this format to create the common medicines market within the Eurasian Economic Union. A brief description of the modules included in the common technical document and their content is provided, as well as general principles of developing an electronic version of the present format. The use of a single electronic format for dossier submission will make it possible to automatically control the completeness of submitted materials and to integrate information systems used by manufactures and regulatory authorities.