History of Drug Registration in Russia and the EAEU, 1918–2026: From Soviet GOSTs to eCTD Dossiers
A regulatory affairs specialist in 2026 lives in a world of eCTD (electronic Common Technical Document) dossiers, GMP (Good Manufacturing Practice) inspections, and digital serialization. Thirty years ago, drug registration in Russia looked entirely different. Seventy years ago, the very concept of «registration» was absent: the state did not register medicines because it produced them itself.
Understanding this evolution helps to make sense of modern rules. Why does the EAEU (Eurasian Economic Union) require the CTD (Common Technical Document) format? Where did the concept of the QP (Qualified Person) originate? Why are transition periods necessary if one could simply introduce new rules?
The answers lie in history, and January 2026 became a natural point to reflect on it. The ten-year transition to the unified pharmaceutical market of the EAEU has now concluded.
The Soviet Model
In the Soviet Union, the pharmaceutical industry operated on a logic far removed from today’s market dynamics. A market did not exist. The state acted simultaneously as the customer, manufacturer, distributor, and regulator. In such a system, registering a medicine lost its purpose — there was no need to «authorize» market entry when the state controlled the entire supply chain.
Instead of registration, a system of state standards (GOSTs) prevailed. The Pharmacological Committee under the USSR Ministry of Health determined which medicines the country needed. The Committee’s decisions were approvals of a centralized production plan, setting nomenclature, production volumes, and distribution among the republics.
Quality was governed by the State Pharmacopoeia. Its first edition in Russia dates to 1866, though collections of requirements for medicines existed earlier. After the revolution, the Pharmacopoeia was republished several times. The 7th Edition of 1926 symbolized a break with the «bourgeois» system. The 10th and 11th Editions remained in force until the collapse of the Union. GOST 17768-90 «Medicinal Products: Packaging, Labeling, Transportation, and Storage,» approved in November 1990, formally remains in force today.
A central institution of this era was the L.A. Tarasevich State Institute for Standardization and Control of Medical Biological Preparations (GISK), founded in 1918. It dealt with immunobiological preparations: vaccines, sera, and blood products. During the Cold War, oversight of these products was elevated to the level of national security.
The Soviet GISK system differed fundamentally from the modern GMP approach. Today, the emphasis is on process control: if the technology is validated and followed correctly, the finished product will be of the required quality. In the USSR, the focus shifted to total laboratory control of every batch. The state controller verified the finished product, not the manufacturing process.
Table 1: Comparison of GISK vs. EAEU GMP
| Parameter | Soviet Model (GISK) | Modern Model (EAEU GMP) |
|---|---|---|
| Focus of control | Laboratory analysis of the finished product for every batch | Control of the manufacturing process and quality system |
| Responsibility | State controller confirms quality | Manufacturer’s QP bears personal liability |
| Methodology | Specific Soviet-standard methods | Harmonized EAEU and Ph.Eur. pharmacopoeial methods |
| Market entry speed | Delayed due to repeated testing in state institutes | Accelerated via parametric release |
The Soviet school of immunology achieved remarkable results. Rigorous testing protocols enabled the eradication of smallpox with an efficiency that decentralized Western systems of that era struggled to match. This «state acceptance» mentality remains deeply rooted in regulatory culture: Russia still maintains a batch-by-batch release procedure for immunobiological medicinal products entering civil circulation.
The system had real drawbacks. The Soviet approach to evidence-based medicine diverged from the Western one. Following the thalidomide tragedy of the 1960s, the US and Europe developed the four-phase clinical trial model with double-blind controls. In the USSR, randomization and placebo use were periodically dismissed as «bourgeois» methods. Preference was given to trials in «real clinical practice,» where effectiveness was evaluated by senior clinicians at elite research institutes.
The drive for autarky — independence from imports — also lowered market entry barriers for domestic developments, compensated by strict post-authorization controls. The isolation created a structural problem: Soviet medicinal products almost never entered Western markets due to incompatible clinical trial standards.
The 1990s: Regulatory Entropy
The collapse of the USSR in 1991 dismantled the unified control system. Fifteen republics became independent states, each building its own pharmaceutical legislation. The period from 1991 to 2015 is best described as an era of regulatory entropy.
In Russia, Federal Law No. 86-FZ «On Medicines» appeared in 1998, introducing the concept of state registration of medicinal products in the market-oriented sense for the first time. Ukraine adopted its law in 1996; Kazakhstan, Belarus, and other republics followed with their own frameworks.
For pharmaceutical companies, the practical consequences were severe. To sell a single product across former Soviet territory, a manufacturer had to navigate separate procedures in each country — five sets of documents, five state fees, five expert organizations with their own requirements.
Requirements frequently contradicted one another. Evidence of safety deemed sufficient in one country could trigger demands for additional clinical trials in another. Registration timelines ranged from a few months to several years. The cost of authorizing a single product varied many-fold across jurisdictions.
The 1990s and 2000s brought a sharp turn toward Western models — attempts to implement GMP, GCP — Good Clinical Practice — and GLP — Good Laboratory Practice — and adoption of dossier formats. Absent coordination, the result was a patchwork of requirements. Holding a Russian Marketing Authorization gave no right to sell in Kazakhstan or Belarus.
The Birth of the EAEU
The Eurasian Economic Union, established on 29 May 2014, united Russia, Belarus, and Kazakhstan (Armenia and Kyrgyzstan joined later). The goal was a supranational body modeled on the European Union.
On 23 December 2014, the member states signed the Agreement on Unified Principles and Rules for the Circulation of Medicinal Products within the EAEU. The document laid the foundation of the modern system, providing for harmonized legislation, unified registration rules, mutual recognition of assessment results, and a common medicinal products register.
The path from political declaration to a working mechanism took more than ten years.
Decision No. 78
On 3 November 2016, the Council of the Eurasian Economic Commission (EEC) adopted Decision No. 78 «On the Rules for Registration and Examination of Medicinal Products for Medical Use» — the document that continues to govern the industry today.
Decision No. 78 established a unified registration procedure based on several principles.
The registration dossier format was aligned with international CTD standards. The dossier consists of five modules: administrative information (Module 1), summaries and quality overviews (Module 2), quality data (Module 3), non-clinical data (Module 4), and clinical data (Module 5). The structure corresponds to ICH — International Council for Harmonisation — requirements.
The concept of a Reference Member State and a Recognized State was introduced. An applicant submits the dossier to one EAEU country (the Reference Member State), which conducts the full assessment. Other countries (Recognized States) accept those assessment results, conducting only a check for national-level specifics.
Unified manufacturing requirements were established through EEC Council Decision No. 77 of 3 November 2016, which approved the EAEU GMP Rules. A manufacturer holding a GMP certificate from one member state can rely on it during registration in any other. Since 2022, member states issue GMP certificates exclusively under EAEU Rules.
A unified Marketing Authorization (MA) number format was also introduced, with the structure LP-No.(XXXXXX)-(YY-ZZ), where YY designates the Reference Member State and ZZ is added upon recognition in other countries.
The Transition Period
Decision No. 78 provided for a transition period. Initially, manufacturers could register medicinal products under national rules until 31 December 2020. All MAs issued under old procedures were to be brought into compliance with EAEU requirements by 31 December 2025.
By 2021 it was clear the industry would not meet that deadline.
The COVID-19 pandemic paralyzed regulatory authorities and manufacturers alike. Border closures made GMP inspections of foreign sites impossible. The EEC introduced temporary relaxations, including remote inspection.
According to market participants, fewer than half of all MAs had been brought into EAEU compliance by mid-2024. Half the market remained on national authorizations.
The situation raised legitimate concerns. If national MAs were annulled from 1 January 2026 as scheduled, thousands of medicinal products would disappear from circulation — including items on the vital and essential drugs (VED) list.
The EEC applied a tactic of regulatory flexibility. Dossier variations could be submitted simultaneously with the compliance procedure, shortening administrative timelines. For manufacturers who submitted applications to add new Recognized States by 31 December 2025, the deadline for completing those procedures was extended to 31 December 2027. EEC Board Decision No. 34 codified this option.
January 2026
The legal landscape changed at the start of 2026.
Registration of new medicinal products under national rules became legally impossible. Any new market entry must follow EAEU Rules — through the mutual recognition procedure or the decentralized procedure.
National MAs whose holders did not file applications for re-registration by 31 December 2025 lapsed. Under Article 164 of Decision No. 78, however, medicinal products manufactured and placed into civil circulation before the MA expiry date may remain on the market in the member state’s territory until the end of their shelf life.
This creates a «long tail» effect: during 2026–2028, packages with different labeling and different regulatory status will legally coexist in pharmacies.
Russian legislation also abolished the provision allowing cancellation of a product’s registration if it had not been on the market for more than three years. From 1 January 2026, Article 32 of Federal Law No. 61-FZ ceases to apply to medicinal products (it remains in force for veterinary medicinal products). The change is aimed at preserving «dormant» registrations under conditions of geopolitical uncertainty — companies can keep products in reserve without risk of losing their MA.
In parallel, the special regime for importing medicinal products in foreign packaging was extended. The draft federal law amending Article 47 of Federal Law No. 61-FZ provides for extending this regime until 31 December 2027. Over 2022–2025, the inter-agency commission issued shortage decisions for 200 medicinal products under this mechanism.
Medical Devices: Extension to 2027
The medical device (MD) market had not completed harmonization by 2026, unlike the pharmaceutical sector. The situation resembles the MDR — Medical Device Regulation — implementation crisis in the European Union, where transition periods were also repeatedly pushed back.
On 29 December 2025, the EAEU member states signed the Protocol on Amending the Agreement on Unified Principles and Rules for the Circulation of Medical Devices, extending the possibility of submitting applications under national rules until 31 December 2027.
The lag behind the pharmaceutical sector reflects several structural differences. The number of medical device SKUs exceeds the number of medicinal products by orders of magnitude. Auditing QMS — Quality Management Systems — under ISO 13485 is more demanding than a standard GMP inspection. There is a shortage of competent inspectors qualified to audit foreign manufacturing sites.
eCTD and Serialization
While the EAEU has shown flexibility on registration timelines, the course toward digital unification is firm.
By 2026, the eCTD format has become the global standard. Japan made eCTD 4.0 mandatory from 2026. The European Union requires it for centralized procedures. The US plans mandatory adoption by 2029. The EAEU is in active transition.
Submitting a dossier as a flat PDF is effectively excluded for new molecules. EAEU standards, approved through EEC Board Decisions, require XML format for new registrations. Version 4.0 allows the regulator to send queries and receive responses directly within the dossier structure, which accelerates the assessment — a two-way channel, not a one-way submission.
The harmonization of quality requirements has advanced in parallel. The EAEU Pharmacopoeia — comprising 157 general pharmacopoeial monographs — has been in force since March 2021. Manufacturers who registered products on the common market were required to bring their quality normative documents into compliance with the Pharmacopoeia by 1 January 2026.
On the serialization side, Russia’s Chestny ZNAK track-and-trace system is integrated with the Unified Information System for public procurement. Payment under government contracts for medicinal products and medical devices is now blocked automatically if the Data Matrix codes have not passed validation or have not been correctly decommissioned in the system.
At the Eurasian Intergovernmental Council meeting in December 2025, the development roadmap for the marking system was approved. The 2026 target is seamless code recognition: a product serialized in Kazakhstan must be visible to the Russian regulator in real time, without re-marking at the border.
From GISK to Algorithms
The regulatory trajectory from the Soviet model to the digital EAEU reveals a structural parallel. The era of liberalization and decentralization was the 1990s. The EAEU of 2026 is a tightly centralized rules framework — the difference is in the instruments. Instead of the laboratory technicians at the Tarasevich GISK checking every ampoule, control is now exercised by eCTD XML schema validation algorithms and Data Matrix traceability systems. The idea of «transparency of every vial» — unattainable for Gosplan — has been implemented through digital technology.
By 2030, automation of regulatory decisions is a realistic prospect. Pilot projects using artificial intelligence for initial dossier validation are already under discussion. Having skipped the long «paper GMP» evolutionary stage, the EAEU has a genuine opportunity to make a technological leap.
Sources: Agreement on Unified Principles and Rules for the Circulation of Medicinal Products within the EAEU, 23 December 2014; EEC Council Decision No. 78 of 3 November 2016 «On the Rules for Registration and Examination of Medicinal Products for Medical Use»; EEC Council Decision No. 77 of 3 November 2016 «On the EAEU GMP Rules»; EEC Board Decision No. 34; Protocol of 29 December 2025 on Amending the Agreement on Unified Principles and Rules for the Circulation of Medical Devices; Federal Law No. 61-FZ of 12 April 2010 «On the Circulation of Medicinal Products»; GOST 17768-90 «Medicinal Products: Packaging, Labeling, Transportation, and Storage.»
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