Marketing Pharmaceutical Products in CIS/Eurasian Economic Union

The interest of pharmaceutical companies in expanding business across the Commonwealth of Independent States (CIS) and the Eurasian Economic Union (EAEU) has been constantly growing. For the same reason, Biomapas provides end-to-end regulatory support in these markets, helping global pharmaceutical and biotech companies navigate local rules, accelerate approvals, and maintain compliance while focusing on development.  

In this article, we discuss marketing pharmaceutical products in CIS and EAEU countries, the region’s regulatory peculiarities, as well as our experience providing Regulatory Affairs (RA) and Pharmacovigilance (PV) services across the market. We also explain about marketing pharmaceutical products in CIS and EAEU countries, and the differences in procedures and legislation compared to the EU. 

Which countries belong to the EAEU and CIS region? 

The CIS is a confederation of 9 full member states and 1 associate member, formed during the dissolution of the Soviet Union and includes most former Soviet republics. As of 2026, the full members are Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, and Uzbekistan. Turkmenistan is an associate member, and Mongolia holds observer status. Ukraine and Georgia are no longer members of the Commonwealth. 

The current Member States of the Eurasian Economic Union are Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. 

What are the main regulatory differences affecting marketing pharmaceutical products in CIS countries and the EAEU? 

In the European Union, the same general rules and regulations apply to all member states, with some national differences. We can submit Marketing Authorisation Applications via Decentralised or Mutual Recognition procedures and obtain MAs in all or at least several countries at once. In the CIS region, except for EAEU Member States, there is no common legislation. This means that if a pharmaceutical company wanted to be present in the region, they have to apply via the national procedure in each country. Post-authorization activities also differ country-by- country. The way variations are classified and handled is a good example of how regulatory requirements differ between the EU and certain CIS markets. 

Regarding differences in Pharmacovigilance requirements across the CIS region, outside the EAEU, these have historically been fragmented, and in many countries the regulatory frameworks have remained less developed compared to the EU. Although several markets had limited formal PV obligations in earlier years, regulatory expectations have strengthened gradually, particularly from 2022 onward. As a result, while pharmaceutical companies previously relied largely on their internal standards to ensure compliance across the region, many CIS authorities now require the appointment of a local pharmacovigilance contact or Local Person for Pharmacovigilance, with expectations that closely mirror the EAEU GVP framework.  

Local literature screening is now explicitly required in many CIS and EAEU jurisdictions as part of routine pharmacovigilance activities. At the same time, reporting timelines for Periodic Safety Update Reports (PSURs) continue to vary country by country, not always align with EU schedules, meaning that companies must still manage national differences carefully. 

What are the main changes and issues that arise for Marketing Authorization Holders concerning the 2017 legislation? 

The pharmaceutical legislation of the EAEU, which came into force in 2017, introduced a unified regulatory framework that significantly reshaped the responsibilities of MAHs. The most notable change was the establishment of a common registration system across all member states, requiring MAHs to prepare dossiers according to harmonized technical standards and enabling mutual recognition of approvals. This also brought stricter rules for variations and lifecycle management, with standardized procedures for amendments to authorizations.  

In addition, pharmacovigilance obligations were expanded, demanding more robust post-marketing surveillance and reporting. During the transitional period, MAHs faced the dual challenge of complying with both national and EAEU requirements, which created administrative burdens, regulatory uncertainty, and risks of delays in converting existing authorizations. Overall, while the legislation aimed to simplify market access in the long term, it imposed significant short-term compliance costs and operational adjustments for MAHs.    

What is the main reason for companies to be interested in marketing pharmaceutical products in CIS countries? 

The first clear reason is the size of the region. CIS, together with Georgia and Mongolia, covers 12 countries with approximately 250 million citizens in total. This scale remains a significant consideration for pharmaceutical companies planning business development and expansion activities across these markets. The CIS region also remains quite specific in terms of healthcare systems, reimbursement practices, business opportunities in particular therapeutic areas (such as infectious diseases), and region‑specific trends, including the growing demand for aesthetic medicine. 

Looking from a CRO perspective, we see two main reasons for the growing demand for Biomapas’ expertise in CIS. The first is the inconsistent quality of local service providers, which often includes language barriers and communication challenges. One outstanding case was of a client requesting Regulatory Affairs (RA) services in CIS. The client reported that the previous company they were cooperating with managed to translate all patient information leaflets using Google Translate; one can only imagine the issues they had afterwards.  

The second important reason for the rising demand for RA and PV support is the 2017 legislation implemented in several countries, which expanded Marketing Authorization Holder responsibilities and introduced a greater number of local obligations, particularly regarding pharmacovigilance activities.  

What are the main Regulatory Affairs and Pharmacovigilance in the CIS region? 

As an example, Biomapas has ongoing RA projects with 15 clients and 10 ongoing PV projects. Most of them cover either the whole region or at least 8-10 countries.  

Initially, finding reliable and experienced Local Regulatory and Local Safety Officers can be quite challenging. In our case, long-standing contacts in the region helped immensely. Another challenge that we faced was the return to paper‑based submissions. Only a few authorities in the region had e-systems, everything had to be submitted on paper, with a number of copies, and many documents had to be annotated. 

What is also important to mention is the language barrier. Even in competent authorities, only a very small number of experts speak English. However, most of them speak Russian due to historical/geographic reasons. We solved this through our team of experienced local RA/PV Managers, who are responsible for the regional projects and speak both English and Russian fluently. They are also aware of the regional and cultural specifics, which is crucial for creating and maintaining effective communication with both competent authorities and our Local Regulatory and Local Safety Officers. 

What would we advise pharmaceutical companies that are interested in marketing pharmaceutical products in CIS countries? 

Firstly, from our experience, we recommend choosing European partners with operational presence in CIS countries, rather than relying solely on local RA/PV service providers. This is mainly related to the quality of service and overall understanding of good business and communication practices. 

Secondly, we strongly advise auditing the company you choose at the very beginning of negotiations. It may require some additional costs, but there is certainty that the selected partner applies the highest operational standards and has a Quality Management System (QMS) in place. At the beginning of Biomapas’ RA and PV services expansion in the CIS region, we were considering partnering with one local company, which seemed quite promising. However, after the audit results, we decided to change our plans as the findings were more than critical. The company did not understand even the principles of QMS and was not willing to cooperate with the auditor. 

Last but not least, do not trust your distributor RA and PV activities until you have proof of performance. Most of them are good in distribution and marketing of products, but do not prioritise RA and PV. Some distributors do not pay significant attention to the importance of post-authorization activities and regulatory requirements. In one case, RA and PV activities were assigned to Biomapas by the client due to significant submission delays of renewals and PSURs, which were the responsibility of the distributor. To summarize, pick your partners carefully and audit them. 

Biomapas Operations in CIS/EAEU 

With 15+ years supporting global pharma and biotech firms in EAEU/CIS markets, Biomapas is recognized for speed-to-market, compliance accuracy, and strategic foresight. Our strong relationships with regulatory agencies across the region ensure smoother approvals and reduced delays. 

“Navigating regulatory complexity across EAEU and CIS markets requires both local knowledge and global experience. At Biomapas, we combine both to provide tailored, compliant solutions for our clients,” says Kristine Davtyan, RA Lead, EAEU & CIS Markets. 

Marketing pharmaceutical products in CIS and EAEU countries is a strong opportunity to expand globally, but it requires a partner who understands the local regulatory landscape from first-hand experience.  

Biomapas provides the expertise, local integration, and operational agility to turn complexity into control.