Russia State Pharmacopoeia XV and the EAEU Pharmacopoeia — Two Deadlines, One Compliance Gap
This autumn brings a deadline the pharmaceutical industry is discussing far more quietly than the one in January. Starting September 1, 2026, normative documentation (ND) for registered medicinal products must comply with the requirements of the State Pharmacopoeia of the Russian Federation, XV edition (SP RF XV). This is a separate deadline, established by Ministry of Health Order No. 377 dated July 20, 2023, and it does not coincide with the EAEU Pharmacopoeia transitional period that ended in January. Three and a half months remain — enough time to act, if you start now.
But before taking action, it is worth understanding: how do these two pharmacopoeias relate to each other? What is new in the SP RF XV compared to previous editions? When does the Union standard apply, and when does the Russian one? And what role does the FSBI «SCEEMP» play in all of this? Article 4 of Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines» (hereinafter — FZ-61) states directly: the quality of a medicinal product is defined as its compliance with the requirements of the pharmacopoeia monograph (PM), and a substandard medicinal product is one that fails to meet those requirements. The pharmacopoeia stands above the manufacturer’s specification — this is not a declaration, but a functional norm of law.
The Origins of the Two-Pharmacopoeia Confusion
Before 2015, the system was simpler. Russia had one State Pharmacopoeia — at that time, the XIII edition was giving way to the XIV. Every enterprise developed ND for its medicinal products, drawing on the general pharmacopoeia monographs (GPMs) and PMs from the current Russian edition. Quality control laboratories operated under a single framework.
After the formation of the Eurasian Economic Union (EAEU) and the creation of a single medicines market, it became clear that five different national pharmacopoeias could not coexist within one union. Quality requirements for the same medicinal product varied from country to country, creating barriers to the mutual recognition of quality control results and contradicting the core idea of a unified market. Work on the EAEU Pharmacopoeia began.
Decision No. 100 of the Board of the Eurasian Economic Commission (EEC) dated August 11, 2020, approved the EAEU Pharmacopoeia. The first part of the first volume entered into force in March 2021: 157 harmonized GPMs containing methods for biological, microbiological, and physicochemical testing. Manufacturers were given a five-year transitional period to bring their ND into compliance. That period ended on January 1, 2026.
In parallel, the Ministry of Health of Russia continued updating the national pharmacopoeia. The SP RF XV appeared in July 2023, bringing with it a separate transitional period for ND: until September 1, 2026. The industry thus found itself with two interconnected but non-identical documents governed by different deadlines. Their relationship is hard to navigate without a clear framework.
How the System Is Structured Now
The State Pharmacopoeia of the Russian Federation, XV edition was approved by Ministry of Health of Russia Order No. 377 dated July 20, 2023 (hereinafter — Order No. 377) and entered into force on September 1, 2023. Order No. 448 of the Ministry of Health dated August 25, 2023, added a supplementary package of GPMs and PMs to the SP XV, which also took effect on the same date. Article 7 of FZ-61 defines the State Pharmacopoeia as a compilation of GPMs and PMs; it is republished at least once every five years, and between editions, supplements containing new monographs are released. The developer is the FSBI «SCEEMP» of the Ministry of Health of Russia (Scientific Centre for Expert Evaluation of Medicinal Products). The procedure for developing and including monographs in the State Pharmacopoeia is governed by Ministry of Health Order No. 468n dated September 13, 2024 (hereinafter — Order No. 468n).
The EAEU Pharmacopoeia was approved by EEC Board Decision No. 100 dated August 11, 2020, and is mandatory for all member states of the Union. Under Order No. 468n, when developing Russian GPMs and PMs, the SCEEMP is legally required to take into account the provisions of the EAEU Pharmacopoeia. This ensures gradual convergence of the two documents, though they are not currently identical.
The hierarchy is established by Article 3 of FZ-61: in areas regulated by EAEU acts, Union law takes precedence over national law. In practice, this means: if the EAEU Pharmacopoeia contains a GPM for a given quality attribute, while the SP RF XV describes the same attribute differently, the Union standard prevails. Where the EAEU Pharmacopoeia has no provision, the SP RF XV applies.
| Parameter | SP RF XV | EAEU Pharmacopoeia |
|---|---|---|
| Status | National regulatory document | EAEU act, mandatory for all member states |
| Developer | FSBI «SCEEMP» of the Ministry of Health of Russia | Expert bodies of EAEU member states |
| Legal Basis | FZ-61, Orders No. 377 and No. 448 (2023), No. 468n (2024) | EEC Board Decision No. 100 dated August 11, 2020 |
| Date of Entry into Force | September 1, 2023 | In stages from March 2021 |
| Deadline for Bringing ND into Compliance | Until September 1, 2026 | Until January 1, 2026 (completed) |
| Priority in Case of Conflict | Applies where EAEU has no provision | Takes precedence over the national norm |
What Is New in the SP RF XV
Compared to the XIV edition, the SP RF XV extends coverage to fundamentally new subject areas and updates several methodological approaches. Three areas carry the greatest practical significance.
Excipients
The excipients section emerged as a direct consequence of amendments to FZ-61. Previously, the control of fillers, solubilizers, and preservatives was entirely delegated to the manufacturer — a supplier’s certificate of analysis was sufficient. Accumulated evidence has shown that excipient purity directly affects the impurity profile and stability of the finished dosage form. Pharmacopoeia monographs have now been approved for a range of items, and a supplier’s CoA is no longer adequate where a PM exists for that substance.
This primarily affects manufacturers of parenteral and ophthalmic dosage forms, where requirements for the impurity profile of excipient components are particularly stringent.
Pharmacy Compounding
The compounding pharmacy section has effectively aligned quality control standards for compounded medicines with those of industrial manufacturing — for the parameters covered by approved GPMs. This became necessary for two reasons. Faced with shortages of certain finished dosage forms, some hospitals turned to in-house compounding, yet no quality control requirements existed. Individualized dosage forms for orphan disease patients are also prepared in compounding pharmacies. The SP RF XV has closed this regulatory gap.
Radiopharmaceutical Medicinal Products
The special requirements for this category stem from the physical properties of these products: most radiopharmaceuticals have a half-life of minutes to hours. Conventional batch release testing that requires waiting for analytical results is physically impossible here. The SP RF XV introduced dedicated GPMs with methods for assessing radiochemical purity and requirements for radiation safety, opening the path to formalized quality control in nuclear medicine.
Removal of Abnormal Toxicity Testing from Mandatory Batch Release
The revised GPMs of the SP RF XV moved abnormal toxicity testing from mandatory batch release into the toolkit of pharmaceutical development. The biological assay on mice or guinea pigs is being replaced by highly sensitive physicochemical methods: HPLC (high-performance liquid chromatography), GC-MS (gas chromatography–mass spectrometry), and ICP-MS (inductively coupled plasma–mass spectrometry). These methods detect impurities at concentrations unattainable by biological testing.
The decision is consistent with the international 3R concept (Replacement, Reduction, and Refinement of laboratory animal use) adopted by the EMA and ICH. For manufacturers, this means lower costs and faster batch release turnaround.
How the Pharmacopoeia Is Updated Now
Order No. 468n replaced the outdated procedure in place since 2010. Understanding how the State Pharmacopoeia is updated means knowing when and how it is possible to influence it.
The SCEEMP develops draft GPMs and PMs, drawing in part on proposals from manufacturers, scientific organizations, and educational institutions. The Ministry of Health publishes completed drafts openly on its official website in PDF format for a period of no less than 30 calendar days. During this window, any participant in the medicine circulation market may submit comments and suggestions. After public consultation, the draft is forwarded to the Council on the State Pharmacopoeia — a dedicated body comprising representatives from science, education, industry organizations, and the Ministry of Health. The Council reviews the draft within 30 calendar days and either recommends it for approval or returns it for revision with a stated justification.
Upon a positive recommendation, technical editing begins: 90 calendar days are allocated for this stage. After approval, the monograph is published on the Ministry of Health website within 10 calendar days. From the start of public consultation to publication takes roughly six months in total — that is the operational planning horizon for manufacturers.
The regulator has created a legitimate channel: industry specialists can shape requirements before they come into force. If a draft GPM contains a disputed methodology, the industry has 30 days to raise the issue.
The Role of the SCEEMP in the Quality Control System
The SCEEMP performs four functions that collectively make it the central hub of the system.
Developing GPMs and PMs for the SP RF is the most visible of the four. Less conspicuous but equally vital: maintaining the registry of pharmacopoeia reference standards (PRS). FZ-61 defines them as the substances against which tested medicinal products are compared during physicochemical and biological quality control. Without a PRS, validation of an analytical method is impossible. As of May 12, 2026, the registry holds 475 types of PRS: 299 of chemical origin, 89 biological, 43 for impurities, 18 for identification, 12 for excipients, 7 of herbal origin, and 7 for system suitability testing.
The third function is interlaboratory proficiency testing (PT): it provides an objective assessment of the competence of both state and private testing laboratories. The fourth is expert evaluation of registration dossiers, which includes assessing the quality control methods proposed by the manufacturer.
Expanding the PRS inventory has been a top priority in recent years, particularly given restricted access to USP (United States Pharmacopeia) and EP (European Pharmacopoeia) standards. The situation is most acute for biological medicinal products: the 89 biological PRSs already represent a solid base, but industry demand in this category remains high.
Action Plan
Three and a half months remain until September 1, 2026. Here are the concrete steps.
Conduct an audit of normative documentation. Review the ND and normative technical documentation (NTD) across your entire portfolio, and identify which edition of the State Pharmacopoeia each document references. If the ND references SP XII, XIII, or XIV, and the methodology for a given parameter has changed in SP XV, the document must be updated. Filing an application to amend the registration dossier is mandatory; the compliance deadline under Order No. 377 is September 1, 2026.
Reconcile ND with the EAEU Pharmacopoeia. For every controlled quality parameter, verify whether a GPM exists in the EAEU Pharmacopoeia. If it does, and it describes the methodology differently from your ND, the Union standard applies (Article 3 of FZ-61). Any discrepancy between ND and the EAEU Pharmacopoeia requirements constitutes grounds for a deficiency notice from the SCEEMP during expert evaluation.
Verify reference standards. If your analytical methods use USP or EP reference standards and a Russian equivalent exists in the SCEEMP registry, transitioning to it reduces operational risk. The PRS catalogue is published on the SCEEMP website.
Set up monitoring for new GPMs and PMs. Under Order No. 468n, all draft monographs are posted on the Ministry of Health website at least 30 days before approval. If upcoming changes affect your portfolio, submit comments within the designated timeframe.
Address the specialized sections of SP XV separately — those on pharmacy compounding and radiopharmaceuticals — if your facility operates in those areas. These requirements are new, and inspection practices around them are still taking shape.
The question of consistent interpretation of methodologies across laboratories in different EAEU member states has not been fully resolved: the same GPM from the EAEU Pharmacopoeia can be interpreted differently by national expert centres. The scientific consultation mechanism at the SCEEMP prior to submitting a registration dossier — provided for under FZ-61 — allows most questions to be resolved in advance, yet it is used far less often than it should be.
The pharmacopoeia system of 2026 is structured differently from five years ago: at that time, the national pharmacopoeia was the sole mandatory standard, and the EAEU Pharmacopoeia was only beginning to be implemented. Today, both systems operate simultaneously, with different deadlines and a clear hierarchy. The task of a quality professional is to apply them in the correct order. The SP XV deadline has not yet passed.
Regulatory Base:
1. Federal Law No. 61-FZ dated April 12, 2010, «On the Circulation of Medicines» (as amended July 23, 2025)
2. Order of the Ministry of Health of the Russian Federation No. 377 dated July 20, 2023, «On the Approval of General Pharmacopoeia Monographs and Pharmacopoeia Monographs» (State Pharmacopoeia of the Russian Federation, XV Edition, effective September 1, 2023)
3. Order of the Ministry of Health of the Russian Federation No. 448 dated August 25, 2023, «On the Approval of General Pharmacopoeia Monographs and Pharmacopoeia Monographs…» (Supplement to the SP RF XV, effective September 1, 2023)
4. Order of the Ministry of Health of the Russian Federation No. 468n dated September 13, 2024, «On the Approval of the Procedure for Developing General Pharmacopoeia Monographs and Pharmacopoeia Monographs and Their Inclusion in the State Pharmacopoeia…»
5. Decision of the Board of the Eurasian Economic Commission No. 100 dated August 11, 2020, «On the Approval of the Pharmacopoeia of the Eurasian Economic Union»