The implementation of a unified market for pharmaceuticals within the EAEU aims to enhance the quality, safety, and efficacy of drugs and medical devices entering the market. Currently, the agreement on a unified pharmaceutical market has been signed by Russia, Armenia, Belarus, Kazakhstan, and Kyrgyzstan. Additionally, approximately 50 countries have expressed interest in collaborating with the Union, as stated by Russian Foreign Minister Sergey Lavrov during a recent governmental session in the State Duma.
Within the project, a unified information platform has been created with the goal of generating a centralized data resource, a common registry containing details about marketing authorizations for medicines within the framework. To date, the EAEU’s unified registry features an up-to-date list of drugs that have received marketing authorizations. By October 2024, the registry included 692 issued registrations.
The regulation is based on best global practices for assessing the quality, safety, and efficacy of pharmaceuticals and medical devices. All EAEU guidelines are highly harmonized with the requirements of international organizations such as ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use), WHO (World Health Organization), EMA (European Medicines Agency), and FDA (Food and Drug Administration). This signifies that we are speaking the same language, which simplifies the drug registration process. If a study design meets international standards, there are typically no problems with registration in Russia.
The unified market will guarantee access to high-quality drugs by reducing barriers related to the specifics of national pharmaceutical markets.
The agreement on a unified market for pharmaceuticals was signed in 2014. This initiated a transition period for harmonizing marketing authorization certificates of drugs in reference countries with the Union’s regulations. In 2018, Belarus received the first two applications for inspections according to the GMP regulations of the Union. In 2019, the EAEU’s unified registry published a list of medicines with marketing authorizations. In 2021, the EAEU’s unified market became fully operational. The first edition of the EAEU Pharmacopoeia was also completed, containing general requirements for clinical trials of drugs. Currently, over 70 guidelines and recommendations for the drug development and marketing authorization within the EAEU have been developed, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Pharmacy Practice (GPV).
It’s worth noting that the transition to EAEU regulatory framework has an impact on key aspects of clinical research. Traditionally, in Russia, for biosimilar studies of foreign origin whose clinical development was conducted outside of the EAEU, a local Phase 3 clinical trial was required. This process was labor-intensive. Today, there is a willingness from regulators to approve local Phase 1 trials (pharmacokinetic equivalence) if the biosimilar is registered out of EAEU and the regulatory authorities approve the trials already conducted abroad.
“In Russia and the EAEU region as a whole, there is a trend towards implementing approaches that simplify the entry of vital drugs into the market, ensuring their availability to patients in the EAEU. Conditional marketing authorization programs, accelerated review procedures, authorization in exceptional cases, and simplified registration pathways for drugs included in the List of Drugs with a Potential for Deficiency (e.g., pembrolizumab, liraglutide, semaglutide) facilitate the faster introduction of modern medicines, including original and biosimilar monoclonal antibody drugs intended for the treatment of cancer, autoimmune, and other socially significant diseases,” says Eugenia Radkova, MD, Head of MedSci Consulting and Excellence at OCT CRO.
Despite significant progress, the implementation of the unified pharmaceutical market of EAEU faces certain challenges. It requires addressing the organization and interaction of pharmaceutical inspectorates in member countries. Additionally, implementing the Union’s GMP system at every enterprise is crucial.
The creation of a unified pharmaceutical market within the EAEU is a complex and multi-stage process requiring coordinated efforts from all participants. Regardless of the existing challenges, the unified framework already ensures access to high-quality medicines and enhances healthcare standards in the EAEU countries.
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[1] http://mirperemen.net/2017/01/lavrov/?
[2] https://portal.eaeunion.org/sites/commonprocesses/ru-ru/Pages/DrugRegistrationDetails.aspx
