X GMP Conference Discusses Convergence of Regulatory Practices within the EAEU

The session “Common Market of Medicinal Products for Human Use in the EAEU” which opened the conference, was attended by representatives of the regulatory authorities of Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia, as well as representatives of the Eurasian Economic Commission.

The Agreement on Common Principles and Rules for the Circulation of Medicinal Products in the EAEU was signed in 2014. Over the past 10 years, significant progress has been made in converging regulatory practices for the common market of medicines in the EAEU’s member states, emphasized the session moderator, Dmitry Galkin, Director of the Department for Pharmaceutical and Medical Industry Development of the Russian Ministry of Industry and Trade and Head of the Pharmaceutical Inspectorate.

He noted that in the context of dynamic globalization of the pharmaceutical industry, approaches to ensuring and controlling product quality are necessarily considered. “Various stages of development, research, production, and market release are often carried out in countries with different regulatory systems and approaches. For instance, multi-stage production chains, sometimes involving several manufacturing sites in different countries contributing to the release of a single drug, which is then supplied to several markets, lead to the necessity of complying with various regulatory requirements. The globalization of the medicines market makes the convergence of regulatory standards and approaches for various stages of the medicinal product life cycle essential.”

He emphasized that the work of states within the Union directly addresses these challenges. “The goal of our work is to create common regulatory frameworks, increase drug accessibility, and enhance the coherence of related approaches so that every patient within our vast Union can be equally confident that they are receiving a high-quality, effective, and safe medicine.”

Participants discussed approaches to inspecting manufacturing sites in EAEU member states. Topics included coordinating the work of inspectorates, approaches to supranational regulation, and the necessary level of development for inspectorates.

Vladislav Shestakov, Director of the FSI “GILS & NP”, spoke about the approaches to planning and scheduling the inspection activities of the Russian GMP inspectorate, highlighting the importance of a responsible and timely submission of inspection applications by the applicant. Responding to the moderator’s questions about the principles of scheduling inspections in each country, representatives of the regulatory authorities demonstrated a similar vision, noting that an approach where companies apply for GMP inspections to several inspectorates at once leads to an inefficient use of the regulator’s limited resources.

As noted by Dmitry Rozhdestvensky, Head of the Section for Coordination of Work in the Sphere of Circulation of Medicinal Products and Medical Devices of the EEC Department of Technical Regulation and Accreditation, cooperation within the EAEU has given a significant impetus to the development of the regulatory systems of the Union’s member states: “Over these 10 years, we have achieved a higher level of maturity in the regulatory systems of each country. For the last two years, the WHO has visited all five states. When it assessed the regulatory system, one of the key elements examined by experts was, in particular, the system of medicinal product circulation. Each of the five states reported using union procedures and received high scores in this aspect. An example of the Union’s economic advantage is optimized costs. One legal consequence is increased transparency in dossier compilation procedures. The main achievement, however, is for the consumer – the accessibility of information about the medicinal product.”

In conclusion, all discussion participants emphasized that, overall, the regulatory systems of the EAEU member states are moving in the same direction. This has an extremely positive impact on the accessibility and safety of medicinal products, though there are still areas for further improvement and development.