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Union market of medicines: first results and first challenges

Union market of medicines: first results and first challenges

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The representatives of the Eurasian Economic Commission (EEC) and the authorized authorities of the Eurasian Economic Union countries discussed practical results achieved so far with the participants of the pharmaceutical market, as well as identified problematic matters that required additional consideration to ensure its proper operation at the International Scientific and Practical Conference "Harmonization of regulatory requirements in creating single market of medicinal products - EAEU and EU experience. Opportunities and challenges, main issues of law enforcement", held in Moscow on October 22-23.

Speaking at the plenary session, Dzhanyl Dzhusupova, Deputy Director of the EEC Technical Regulation and Accreditation Department, noted: "The Eurasian Economic Commission jointly with all sides has performed a herculean task. It is based on three systems that ensure smooth functioning of the single market and access of medicines to it. First of all, it is a regulatory documentation system, which includes 47 regulatory acts. Secondly, it is a unified codification system consisting of 34 reference books and classifiers on medicinal products and medical devices being created for the first time at the level of a regional entity, which is fully integrated into the international system of supervision over the safety of medicinal products. And, thirdly it is a unified information system from the register of medicinal products and related information bases. It enables a transparent transboundary review of master files and lays the foundation for mutual recognition of results of researches on quality, safety and efficiency of medicinal products". 

Public expert reports posted in the unified information system of the Eurasian Economic Union have formed the basis for transparent registration process. In these reports, the consumers of medicines, doctors and patients can get acquainted with the results of evaluating a medicinal product, evidences of its action, and safety assessment given to this medicinal product by Ministries of Healthcare of the Member States and expert organizations.

Yuri Olefir, Director of the Russian Scientific Center for Expert Evaluation of Medical Products, drew attention of the conference participants to the need for annual filing of 2,000 to 2,500 applications for registering medicinal products in order to ensure smooth transition to circulation of medicines within the Union registration by 2025. The representative of Kazakhstan Timur Zhienbayev focused on the main remarks stated by expert organizations in evaluating medicinal products, while the Head of the Belarusian Inspectorate Elena Lavnik told about the inspection procedure in the EAEU.

Besides, the representative of the regulatory authority of Armenia Tatevik Yeritsyan voiced at the plenary session the initiative on the need to simplify registration procedures for pharmaceuticals that have already passed the pre-qualification procedure of the World Health Organization (WHO) or the International Council for Harmonization (ICH).

Assessing the advantages of the single market of medicinal products, Dzhanyl Dzhusupova stressed: "First of all, small markets where pharmaceuticals had been introduced with difficulty, often with no interest in developing such markets, get ahead in the Union. The market globalization opens access to medicines not only to countries with large markets, but also to those with small markets. However, it is wrong to consider the single market only from this perspective: a common space for countries with large pharmaceutical markets contributes to developing interstate market cooperative ties as well as stimulates the development of related areas - logistics systems, artificial intelligence systems and Internet technologies. As a result, all these processes will lead to improving the quality of patients' life, renovating diagnostic systems and will help people in treating various diseases".