Russia’s State Pharmacopoeia XV Edition: 1,122 Monographs, 46% New. What Manufacturers Must Do Before September 2026
Three months remain until September 1, 2026. By this date, manufacturers and marketing authorisation holders are required to bring their normative documentation (ND) for medicinal products (MPs) and pharmaceutical substances into compliance with the requirements of the State Pharmacopoeia of the Russian Federation XV Edition (SPRF XV). Some companies have already completed this work; others are only beginning to approach it. Let us break down what has changed in the new pharmacopoeia, how it differs from the XIV edition, how it has been expanded from 2023 to 2025, and what actually needs to be done in the time remaining.
In January 2026, the State Pharmacopoeias of the X, XI, and XII editions officially ceased to have effect. For years, many companies relied on methods from exactly those volumes — particularly where the corresponding monographs had not yet appeared in the XIV and XV editions or required additional recalculations. Appealing to those editions now has no legal force.
How We Worked Before
The XIV edition of the State Pharmacopoeia was in effect from 2018 to 2023. It was the first edition to systematically incorporate the requirements of the EAEU Pharmacopoeia. That integration was partial: some methods remained uncoordinated, and several sections were simply absent.
Excipients as an independent object of standardisation were virtually unaddressed in the XIV edition — everything was reduced to the substance manufacturer’s Certificate of Analysis. This created a specific problem: if a company changed an excipient supplier, it was formally under no obligation to re-verify the impurity profile of the finished product against pharmacopoeial requirements. When a supplier changed, all responsibility rested with the manufacturer’s GMP system, without any independent government reference point.
Pharmacy compounding was regulated mainly through methodological letters, without a single pharmacopoeial standard. Compounding pharmacies operated with fragmented documentation, and requirements varied significantly across regions. Radiopharmaceuticals were also on the periphery of regulation, even as the nuclear medicine segment was actively developing.
Abnormal toxicity testing using laboratory animals was retained in most General Pharmacopoeial Monographs (GPMs). Its sensitivity to specific impurities proved lower than that of modern physico-chemical methods, yet no replacement was made in regulatory documents for a long time. The industry bore real costs: maintaining animal facilities, servicing biological models, and waiting for results.
What Changed with the XV Edition
By Order of the Ministry of Health of Russia No. 377 dated July 20, 2023, «On the Approval of General Pharmacopoeial Monographs and Pharmacopoeial Monographs,» the XV edition was introduced. It entered into force on September 1, 2023. The initial version comprised 313 GPMs and 564 Pharmacopoeial Monographs (PMs), totalling 877 documents. Since then, the pharmacopoeia has been expanded through four appendices.
Chronology of Updates 2023–2025
| Order | Date | Content |
|---|---|---|
| No. 377 | 20.07.2023 | Initial version: 313 GPMs + 564 PMs |
| No. 120 | 13.03.2024 | Additional GPMs and PMs |
| No. 591 | 31.10.2024 | OFS.1.7.2.0001 «Flocks of birds for vaccine production» |
| No. 57 | 06.02.2025 | GPMs on recombinant DNA and monoclonal antibodies |
| No. 188 | 11.04.2025 | 97 GPMs and PMs in a single package |
As of May 2026, SPRF XV contains 1,122 monographs: 330 General Pharmacopoeial Monographs (GPMs) and 792 Pharmacopoeial Monographs (PMs). Of these, 114 GPMs and 401 PMs were introduced for the first time — meaning 515 monographs out of 1,122 (46%) had no equivalent in any previous edition. Order No. 188 of April 2025 was the largest single-package addition since the initial version: 97 documents at once. It closed most of the gaps the industry had flagged in 2023–2024.
Main Differences from the XIV Edition
To appreciate the scale of the changes, it helps to view the key parameters side by side.
| Parameter | SPRF XIV (2018) | SPRF XV (2023–2025) |
|---|---|---|
| Total monographs | approx. 800 | 1,122 |
| Excipients | no separate section | section 2.7 |
| Pharmacy compounding | methodological letters | section 1.8 (pharmacopoeial status) |
| Radiopharmaceuticals | fragmented | section 3.5 |
| Animal testing | retained in most GPMs | removed from 12 GPMs and 4 PMs |
| Biotechnological MPs | limited scope | new GPMs on rDNA and monoclonal antibodies |
| Procedure for GPM/PM development | 2010 order | Order No. 468n dated 13.09.2024 |
The difference is not only quantitative. The XIV edition established the analytical infrastructure — what to measure and how. The XV edition answers questions the market accumulated over five years: what to do with excipients of uncertain origin, how to standardise pharmacy compounding, and how to work with nuclear medicine products.
Excipients
Section 2.7 appeared in the pharmacopoeia for the first time. It establishes requirements for fillers, solubilisers, and preservatives. Nothing of this kind existed as a standalone block in any previous edition. This is a direct consequence of amendments to Federal Law No. 61-FZ dated 12.04.2010 «On the Circulation of Medicines,» which clarified the status of excipients as objects of standardisation; the pharmacopoeia received the corresponding section accordingly.
The manufacturer now has a government reference point for impurity levels and the purity of excipient components. Relying solely on the supplier’s COA (Certificate of Analysis) is no longer considered sufficient justification. Accumulated data have long demonstrated that the purity of fillers and preservatives significantly affects the impurity profile of the finished product and its stability over its shelf life.
Pharmacy Compounding
Through section 1.8, requirements for pharmacy-compounded products have received pharmacopoeial status. For orphan patients and individualised dosage forms, this means compounding pharmacies now bear the same regulatory responsibility for quality as industrial manufacturers. Transparency of requirements has increased, but so has the volume of work required to update internal regulations.
Radiopharmaceuticals
The specific nature of radiopharmaceuticals is well known: an extremely short half-life, preparation immediately before administration. Section 3.5 addressed this gap: the new GPMs account for radiation safety requirements and establish a methodology for evaluating radiochemical purity. For nuclear medicine centres working with PET radiopharmaceuticals, this is a practical tool that previously simply did not exist as a pharmacopoeial standard.
The 3R Concept
Abnormal toxicity tests were removed from 12 GPMs and 4 PMs. Instead of a biological test on mice, laboratories now use HPLC, GC-MS, and ICP-MS — with significantly higher sensitivity to specific impurities. This step is consistent with international ethical norms (the 3R concept: Replace, Reduce, Refine) and reduces the cost of routine batch release testing. Companies will notice the difference in costs in practice.
Biotechnological Products
Particular attention should be paid to two documents added by Order No. 57 in February 2025. OFS.1.7.1.0007 covers medicinal products obtained using recombinant DNA technology. OFS.1.7.1.0014 covers monoclonal antibodies for medical use. Both monographs are harmonised with those of the European Pharmacopoeia (EP) and the United States Pharmacopeia (USP), which for manufacturers of biotechnological products means a fundamentally different situation: the methodological framework of domestic regulatory control is now comparable to that of Western pharmacopoeias.
Connection with the EAEU Pharmacopoeia
When developing new GPMs and PMs, the Ministry of Health is required to take the EAEU Pharmacopoeia into account. This is an explicit requirement of paragraph 2 of Order No. 468n. The EAEU Pharmacopoeia was approved by Decision No. 100 of the Eurasian Economic Commission (EEC) Board dated 11.08.2020 and is mandatory for all Union member states.
For manufacturers registering products in several EAEU countries simultaneously, this is good news: compliance with SPRF XV means technical convergence with the requirements of the EAEU Pharmacopoeia. There is no complete overlap — the Union document has its own structure, and some of its monographs are broader than their Russian counterparts. But the gap between the two pharmacopoeias is consistently narrowing, which reduces the volume of duplicate work when preparing dossiers for registration across different markets of the Union.
The transitional period for bringing ND into compliance with the EAEU Pharmacopoeia expired on January 1, 2026. Combined with the national deadline of September 1, 2026, companies are closing two parallel obligations simultaneously. For some ND, this is a single task; for others, these are two separate processes.
New Procedure for Monograph Development
Ministry of Health Order No. 468n dated September 13, 2024, approved the Procedure for the development of GPMs and PMs and their inclusion in the state pharmacopoeia. The document established a mandatory State Pharmacopoeia Council — a collegial body comprising representatives of science, industry, and the Ministry of Health — and formalised public consultation on draft monographs. Any draft is now published on the Ministry of Health website for at least 30 calendar days; companies may submit comments by post or email. The industry makes use of this opportunity, and it does influence the final texts.
The procedure takes time. The National Centre for Expert Evaluation of Medicinal Products (NCEESMP) develops a draft, the Ministry of Health publishes it for 30 days, the Council reviews it in light of comments received (another 30 days), followed by editing and issuance of the order (90 days). At least six months pass from the completion of development to an approved monograph. Anyone waiting for a specific PM to appear before beginning to update their ND is very likely to run out of time.
Metrological Base and Pharmacopoeial Reference Standards
A separate issue is the physical availability of control tools. Pharmacopoeial Reference Standards (PRSs) are produced by NCEESMP; the registry is maintained on the regmed.ru website. By the end of 2024, it contained more than 370 items, of which 81 relate to biological medicines. Over 2024, the registry grew by 136 entries — more than in any previous year.
In parallel, NCEESMP established a Department of Interlaboratory Proficiency Testing (PT). Participating in PT allows a manufacturer to verify its own results, identify systematic errors in methods, and prepare in advance for potential discrepancies during state quality control of batches.
Russian PRSs are significantly cheaper than EP and USP reference standards. Since 2022, access to Western standards has become more difficult, and for companies focused on the Russian market, switching to domestic PRSs is justified both economically and logistically.
What Will Happen After September 2026
The deadline of September 1, 2026, does not mean the pharmacopoeia will stop evolving. Under Federal Law No. 61-FZ, the State Pharmacopoeia is republished at least once every five years. The XV edition came out in 2023; the next can be expected no later than 2028. Between editions, appendices with new and updated monographs are released — which has been happening continuously since 2023.
For the industry, this means a continuous process of updating ND. Companies that have built a system for monitoring new Ministry of Health orders on the pharmacopoeia will respond faster. Others will once again face rush revision exercises, much like the current situation.
N-nitrosamine impurities deserve separate mention. Control of N-nitrosamines is established in the ICH M7(R2) guideline and is actively discussed within the EAEU. Part of the methodology is already embedded in international monographs. The appearance of corresponding GPMs in the Russian pharmacopoeia is a matter of time. Those who prepare in advance will avoid surprises.
What to Do
The deadline of September 1, 2026, is set out in paragraph 4 of Order No. 377: normative documentation for PMs and MPs must be brought into compliance with the GPMs and PMs of SPRF XV. Three months is entirely workable if approached systematically. The law does not establish separate administrative sanctions specifically for ND non-compliance with the pharmacopoeia, but outdated normative documentation creates exposure during state batch quality control and any audit inspection.
Conduct an audit of your normative documentation. Compile a complete registry of quality ND for all manufactured MPs and substances. For each document, check which GPMs and PMs from SPRF XV it must reference, and whether approved monographs already exist for each dosage form and substance in your portfolio. Group by status: update completed (green), in progress (yellow), not started (red).
Prioritise Essential Medicines List (EML) products and those with tight timelines. If the ND for an Essential Medicines List product is not brought into compliance on time, this is a direct regulatory risk to supply. These items are addressed first. Special attention should go to products where changes are simultaneously being made on other grounds: it is best to consolidate each such change into a single submission package.
Order any missing Pharmacopoeial Reference Standards (PRSs). The SPRF PRS registry is maintained by NCEESMP (FSBI «NCEESMP» of the Ministry of Health of Russia). By the end of 2024, the registry contained more than 370 entries, including 81 standards for biological products. For some monographs, the PRS is released with a delay after the monograph approval date. If the required PRS is in the registry but out of stock, the challenge is logistical. If it is absent from the registry entirely, contact NCEESMP to enquire about the expected release date.
Review control methods in sections where animal testing has been removed. For GPMs from which the abnormal toxicity test was removed, internal Standard Operating Procedures (SOPs) and analytical methods will need to be updated. If HPLC or ICP-MS equipment is already available in the laboratory, only an SOP update is required. If the equipment is not present, procurement and qualification lead times must be factored in now. Qualification of analytical equipment alone typically takes several weeks.
Use the SPRF forum and NCEESMP consultative mechanisms. For atypical dosage forms, rare substances, and biological products, NCEESMP maintains a forum at pharmacopoeia.regmed.ru. Guidelines for the application of GPMs are published there. A question submitted through the official channel is recorded and may serve as the basis for a formal clarification letter — which is preferable to making the wrong decision in silence.
Technically, amending quality ND to bring it into compliance with the pharmacopoeia is formalised as a Type II variation (or via a notification procedure, depending on the significance of the change) within an existing dossier. For products with EAEU marketing authorisations, the procedure for submitting variations is governed by EEC Council Decision No. 78 dated 03.11.2016 «On the Rules for Registration and Expert Evaluation of Medicinal Products for Medical Use.» Products with Russian marketing authorisations operate under the corresponding national procedures.
September 2026 is not the final milestone. It is rather a dividing line separating companies whose ND is current and pharmacopoeia-compliant from those who will at some point receive a compliance notice following a GMP inspection or a state batch quality control finding. The regulatory infrastructure of SPRF XV is in place, PRSs are being produced, and the NCEESMP forum is active. The tools exist. The only question is whether to begin now or to explain to the regulatory authority later why a normative document still references revoked monographs.
Three months is enough for those who know their portfolio and understand where to start. For everyone else, this is the last point at which the situation is still manageable.
Regulatory Framework:
1. Federal Law No. 61-FZ dated 12.04.2010 «On the Circulation of Medicines»
2. Order of the Ministry of Health of Russia No. 377 dated 20.07.2023 «On the Approval of General Pharmacopoeial Monographs and Pharmacopoeial Monographs» (SPRF XV, initial version, in force from 01.09.2023)
3. Order of the Ministry of Health of Russia No. 120 dated 13.03.2024 (Appendix to SPRF XV)
4. Order of the Ministry of Health of Russia No. 591 dated 31.10.2024 (Appendix to SPRF XV)
5. Order of the Ministry of Health of Russia No. 57 dated 06.02.2025 (Appendix to SPRF XV)
6. Order of the Ministry of Health of Russia No. 188 dated 11.04.2025 (Appendix to SPRF XV)
7. Order of the Ministry of Health of Russia No. 468n dated 13.09.2024 «On the Approval of the Procedure for the Development of General Pharmacopoeial Monographs and Pharmacopoeial Monographs»
8. EEC Council Decision No. 78 dated 03.11.2016 «On the Rules for Registration and Expert Evaluation of Medicinal Products for Medical Use»