130+ Regulatory Affairs Terms: A Glossary for EAEU Pharmaceutical Regulation Specialists
A regulatory affairs specialist works with dozens of abbreviations and terms every day. A colleague from manufacturing asks about a PSMF, the regulator requests a QP Release, and a new EEC decision references the «3+2» mechanism. Without a single reference, it is easy to get lost.
This glossary compiles terms encountered in regulatory affairs work in 2026. It covers seven segments: general regulatory concepts, medicines, medical devices, dietary supplements and cosmetics, veterinary products, disinfectants, and classification codes. All definitions are based on current EAEU and Russian Federation legislation.
General Regulatory Terms
Work in regulatory affairs begins with an understanding of fundamental concepts, the structure of supervisory authorities, and the mechanisms by which products reach the market.
Table 1: Core Regulatory Concepts
| Term | Full Name | Definition |
|---|---|---|
| EAEU | Eurasian Economic Union | International regional economic integration organization comprising Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan |
| EEC | Eurasian Economic Commission | The EAEU’s permanent supranational regulatory body, issuing decisions binding on all member states |
| RLA | Regulatory Legal Act | An official document establishing mandatory requirements |
| GxP | Good x Practice | The collective designation for the family of Good Practice standards: GMP, GCP, GLP, GDP, GPP, GVP |
Table 2: Regulatory Authorities of the Russian Federation
| Authority | Full Name | Area of Responsibility |
|---|---|---|
| Ministry of Health | Ministry of Health of the Russian Federation | Registration of medicines, maintaining the VED list, approval of clinical guidelines |
| Roszdravnadzor | Federal Service for Surveillance in Healthcare | Oversight of medicines and medical devices, GMP inspections, pharmacovigilance, authorization of clinical trials for medical devices |
| Rospotrebnadzor | Federal Service for Surveillance on Consumer Rights Protection | State registration of dietary supplements, disinfectants, and cosmetics (SRC); sanitary and epidemiological oversight |
| Rosselkhoznadzor | Federal Service for Veterinary and Phytosanitary Surveillance | Registration of veterinary medicines, oversight of feed additives |
| Minpromtorg | Ministry of Industry and Trade of the Russian Federation | Issuing GMP compliance conclusions (GMP certificates), licensing of medicine manufacturing |
Reference Member State — the EAEU country whose experts conduct the primary full review of a registration dossier. The applicant selects the Reference Member State when filing an application under the EAEU procedure.
Recognized State — a member state that accepts the expert conclusions of the Reference Member State. Recognized states conduct an abbreviated review and make their own authorization decisions on their territory.
Qualified Person (QP) bears personal responsibility for releasing each product batch to market. The QP confirms that the batch was manufactured in compliance with the registration dossier and GMP requirements.
Chestny ZNAK — Russia’s national digital labeling and product traceability system. Mandatory labeling for medicines has been in place since 2020; for certain categories of medical devices, since 2021.
Transition period — the interval during which national marketing authorizations remain valid alongside EAEU registration. For medicines, the baseline deadline for bringing dossiers into EAEU compliance was December 31, 2025; however, under EEC Council Decisions No. 34 (May 22, 2025) and No. 77 (September 12, 2025), applicants who filed before that date may retain their national MAs for up to 3+2 years. For medical devices, the transition period has been extended to December 31, 2027 (Protocol of December 29, 2025 to the Agreement of December 23, 2014).
The «3+2» mechanism allows a national MA for a medicine to remain valid while an application to bring the dossier into EAEU compliance is under review. If the application was submitted before December 31, 2025, the national MA is extended for the duration of the procedure in the Reference Member State (up to 3 years), followed by an additional period of up to 2 years to complete the procedure in the Recognized States.
Medicines
Regulation of medicine circulation sits at the center of regulatory affairs work. The governing rules are the EAEU framework (EEC Council Decision No. 78 of November 3, 2016) and national legislation (Federal Law No. 61-FZ of April 12, 2010).
Core Concepts
Table 3: Key Terms in the Medicines Sector
| Term | Abbreviation | Definition |
|---|---|---|
| Medicinal substance | — | A substance or combination of substances intended for prevention, diagnosis, or treatment of disease |
| Medicinal product | — | A medicinal substance in finished dosage form |
| Active pharmaceutical ingredient | API | The active substance of a medicine that produces the therapeutic effect |
| Marketing Authorization | MA | Document confirming the right to circulate a product on the territory of a state or the EAEU |
| International Nonproprietary Name | INN | Unique name for an active substance assigned by the WHO |
Excipients — components of a dosage form that carry no therapeutic activity. They ensure stability, bioavailability, and ease of use.
Dosage form — the physical state of a medicine that determines its route of administration and dosing: tablets, capsules, solutions for injection, ointments, suppositories, and others.
Batch (lot) — the quantity of product produced in a single manufacturing cycle. Each batch has a unique number and is accompanied by a batch production record.
Prescription medicine (Rx) is dispensed at the pharmacy only on a physician’s prescription. An over-the-counter medicine (OTC) is available without a prescription. The dispensing category is determined by the Ministry of Health at registration.
Summary of Product Characteristics (SmPC) contains full information about a medicine for healthcare professionals: indications, contraindications, dosage, adverse reactions, and interactions. It is approved at registration and updated when changes are made to the dossier.
Registration and Dossier
Registration dossier — the set of documents submitted for registration, covering quality, safety, and efficacy data.
CTD (Common Technical Document) — the standardized dossier format used in the EAEU, EU, US, and Japan. It consists of five modules.
eCTD (electronic CTD) — the electronic submission format. Version eCTD 4.0, current in 2026, is based on XML messaging and conforms to the HL7 standard.
Table 4: Structure of the CTD Registration Dossier
| Module | Content |
|---|---|
| Module 1 | Administrative information: application form, applicant details, packaging mock-ups, package leaflet |
| Module 2 | Summaries and overviews: quality, pre-clinical, and clinical data summaries for reviewers |
| Module 3 | Quality data: information on the active substance, manufacturing process, controls, and stability |
| Module 4 | Pre-clinical data: results of pharmacological and toxicological studies |
| Module 5 | Clinical data: results of studies conducted in humans |
Generic medicine contains the same API as the reference product, in the same dosage and form. Registration follows an abbreviated procedure without full clinical trials — bioequivalence studies are conducted instead.
Biosimilar — a biological medicine similar in quality, efficacy, and safety to an already registered reference biological product. Unlike generics, biosimilars cannot be exact copies due to molecular complexity, so their registration requires independent clinical data.
Bioequivalence — a comparative measure of bioavailability between a generic and the reference product. If the 90% confidence interval for Cmax and AUC falls within 80–125%, the products are considered bioequivalent.
Reference product — the original medicine against which bioequivalence is established or with which the biosimilar is compared.
Orphan medicine is intended for the treatment of rare (orphan) diseases. In Russia, a rare disease is defined as one with a prevalence of no more than 10 cases per 100,000 population (Federal Law No. 323, Article 44).
Biological (biotechnology) medicine — a medicine whose active substance is produced from or extracted from a biological source. Examples: monoclonal antibodies, recombinant proteins, vaccines, blood products. Registration of biologics requires an expanded data package compared to chemical molecules.
Herbal medicine contains plant material or plant extracts as active substances. Registered under specific rules that allow the use of traditional use data.
Homeopathic medicine is manufactured using homeopathic technology described in a pharmacopoeia. Registered under a simplified procedure without clinical efficacy data.
Manufacturing and Quality
Table 5: Terms in Manufacturing and Quality Control
| Term | Abbreviation | Definition |
|---|---|---|
| Good Manufacturing Practice | GMP | System of requirements for production and quality control |
| Quality Control | QC | Sampling, testing, and conformity assessment |
| Quality Assurance | QA | The system of activities that ensures products meet requirements |
| Pharmaceutical Quality System | PQS | Quality management system across the entire product lifecycle |
| Good Laboratory Practice | GLP | Standard for conducting pre-clinical safety studies |
GMP certificate (compliance conclusion) confirms that a manufacturing site meets Good Manufacturing Practice requirements. Issued by Minpromtorg following an inspection, valid for 3 years. Without this document, medicine registration is not possible.
Validation — documented confirmation that a process, method, or system meets specified requirements and delivers reproducible results. Includes process validation, analytical method validation, and cleaning validation.
Qualification — documented confirmation that equipment performs to specification. Stages: IQ (installation qualification), OQ (operational qualification), and PQ (performance qualification).
Specification — quality requirements for raw materials, intermediates, or finished products: a list of attributes, test methods, and acceptance criteria.
Deviation — a departure from an approved procedure or specification. All deviations are documented and investigated within the quality system.
CAPA (Corrective and Preventive Actions) — actions taken to eliminate the causes of nonconformities and prevent their recurrence.
Clean room — a facility in which particle and microorganism counts are controlled. Cleanliness classes A, B, C, D are defined in Annex 1 to the GMP Rules (Minpromtorg Order No. 916).
Stability of a medicinal product — the ability to retain properties within defined specifications throughout the shelf life. Stability studies follow ICH Q1A standards (for Zone IV, which includes Russia: 30°C / 65% relative humidity).
Pharmacopoeia — a compendium of quality standards and requirements for medicines. The State Pharmacopoeia of the Russian Federation is approved by the Ministry of Health. The EAEU Pharmacopoeia is harmonized across member states.
Distribution and Storage
Table 6: Distribution, Storage, and Pharmacy Practice Standards
| Term | Abbreviation | Definition |
|---|---|---|
| Good Distribution Practice | GDP | Standards for wholesale distribution of medicines |
| Good Storage Practice | GSP | Storage standards: temperature control, humidity, light protection |
| Good Pharmacy Practice | GPP | Standards for retail pharmacy operations |
Cold chain — continuous maintenance of a specified temperature range at every stage of storage and transportation for temperature-sensitive products. Especially relevant for vaccines and biologics (typically +2…+8°C).
Pharmaceutical activity licensing — mandatory authorization for wholesale and retail trade in medicines, and for manufacturing. Roszdravnadzor issues licenses for pharmaceutical activities; Minpromtorg issues licenses for manufacturing.
Clinical Trials
Table 7: Terms in Clinical Research
| Term | Abbreviation | Definition |
|---|---|---|
| Clinical trial | CT | Study of a medicine in humans to obtain safety and efficacy data |
| Good Clinical Practice | GCP | International standard for the conduct of clinical trials |
| Contract Research Organization | CRO | An organization that conducts clinical trials under contract |
Phase I — first-in-human studies. Conducted in healthy volunteers (usually 20–100 people) to evaluate safety, tolerability, and pharmacokinetics.
Phase II — studies in patients with the target disease (100–500 people). Determines effective dose and evaluates short-term safety.
Phase III — confirmatory studies in a large population (1,000–5,000 patients). Confirms efficacy and safety for the registration submission.
Phase IV — post-registration studies to investigate rare adverse effects and long-term safety.
Pharmacokinetics (PK) studies how the body acts on a medicine: absorption, distribution, metabolism, and elimination. Key parameters: Cmax (maximum concentration), Tmax (time to Cmax), AUC (area under the concentration–time curve), T½ (elimination half-life).
Pharmacodynamics (PD) studies how a medicine acts on the body: mechanism of action, dose–response relationship, therapeutic and toxic effects.
Informed consent — a subject’s voluntary agreement to participate in a clinical trial after receiving full information about its objectives, methods, and risks.
Study protocol — a document describing the objectives, design, methodology, and organization of a clinical trial. Approved before patient enrollment begins.
Pharmacovigilance
Table 8: Pharmacovigilance Terms
| Term | Abbreviation | Definition |
|---|---|---|
| Pharmacovigilance | PV | Post-market safety monitoring of medicines |
| Good Vigilance Practice | GVP | Standards for pharmacovigilance activities |
| Adverse reaction | AR | An unintended unfavorable reaction associated with the use of a medicine |
| Pharmacovigilance System Master File | PSMF | Master file of the MA holder’s pharmacovigilance system |
| Qualified Person for Pharmacovigilance | QPPV | The person bearing personal responsibility for pharmacovigilance |
Serious adverse reaction — one that results in death, is life-threatening, requires hospitalization, causes permanent disability, or leads to congenital anomalies.
Unexpected adverse reaction — a reaction whose nature, severity, or outcome does not match the information in the approved product labeling.
Safety signal — an indication of a new potential causal relationship between a medicine and an adverse event, requiring further assessment.
ICSR (Individual Case Safety Report) — the standard format for transmitting adverse reaction reports between MA holders and regulatory authorities.
PSUR (Periodic Safety Update Report) — submitted by the MA holder at defined intervals. Contains a benefit–risk analysis for the reporting period.
Risk Management Plan (RMP) describes the safety profile of a medicine and the measures in place to minimize risks.
MedDRA — Medical Dictionary for Regulatory Activities; an internationally standardized terminology for coding adverse reactions and medical conditions.
Pricing and Access
VED list (Vital and Essential Drugs) — the list approved by the Russian Government. Prices for medicines on this list are state-regulated: manufacturers register a ceiling ex-factory price, and regions set maximum wholesale and retail markups.
Ceiling manufacturer price — the maximum selling price for a VED list medicine. Registered with the Ministry of Health; sales above this price are prohibited.
Wholesale markup — the difference between a distributor’s price and the manufacturer’s price. For VED list products, the maximum markup is set by regional authorities.
Retail markup — the difference between the pharmacy price and the wholesale purchase price. Also regulated by regional authorities for VED list medicines.
Special Procedures and Regimes
Accelerated registration procedure applies to medicines for serious, life-threatening conditions with no alternative therapy available. The review period is reduced to 80 working days.
Mutual recognition procedure allows the expert conclusions of one EAEU member state to be used as the basis for obtaining an MA in other member states.
Bringing into compliance (dossier alignment) — the procedure for updating a medicine’s registration dossier from national to EAEU requirements. Applications must be submitted to the Reference Member State by December 31, 2025 (EEC Council Decision No. 34 of May 22, 2025).
Variations (dossier changes) — the procedure for amending documents of a registered medicine. Type IA: minor changes (notification only); Type IB: minor changes subject to review delay; Type II: major changes (requiring assessment).
Intellectual Property
Data exclusivity — the period during which the regulator may not use the originator’s data to register generics. The duration varies across EAEU member states.
Patent protection for a medicine may cover the molecule, the dosage form, the manufacturing process, or a new indication. Patent expiry opens the market to generics and biosimilars.
Compulsory license — authorization to manufacture a patented medicine without the patent holder’s consent. Granted by court or government decision in the interests of national defense, security, or in emergency situations.
Parallel import — importation of an original product without the rights holder’s authorization through unauthorized distributors. In Russia, a parallel import mechanism for medicines has been in place since 2022 for specific products.
Medical Devices
Regulation of medical devices in the EAEU is governed by EEC Council Decision No. 46 of February 12, 2016. The transition period for medical devices has been extended to December 31, 2027 (Protocol of December 29, 2025 to the Agreement of December 23, 2014). Until that date, manufacturers and importers may choose between national or EAEU registration procedures. From January 1, 2028, only EAEU registration will be available.
Table 9: Key Terms in the Medical Devices Sector
| Term | Abbreviation | Definition |
|---|---|---|
| Medical device | MD | An instrument, apparatus, software, or other product used for medical purposes |
| Quality Management System | QMS | A management system ensuring product quality (typically per ISO 13485) |
| Software as a Medical Device | SaMD | Standalone software that performs a medical function |
| Software in a Medical Device | SiMD | Software embedded in a medical device as one of its components |
| Clinical Decision Support System | CDSS | AI- or algorithm-based software assisting clinicians in diagnosis and treatment decisions |
| In vitro diagnostics | IVD | Devices for in vitro diagnosis: test kits, reagents, analyzers |
Risk class determines the category of a medical device based on the degree of hazard to the patient and user.
Table 10: Classification of Medical Devices by Risk Level (EAEU)
| Class | Risk Level | Examples | Conformity Assessment |
|---|---|---|---|
| 1 | Low | Bandages, crutches, corrective eyeglasses | Declaration of conformity (self-declared) |
| 2a | Medium-low | Hearing aids, contact lenses, catheters | Certification |
| 2b | Medium-high | Ventilators, defibrillators, orthopedic implants | Certification |
| 3 | High | Pacemakers, stents, cardiac valve prostheses | Certification |
Technical documentation (technical file) — the set of documents demonstrating that a medical device meets applicable requirements. The equivalent of a registration dossier for medicines: device description, risk analysis, evidence of safety and performance.
ISO 13485 — the international standard for quality management systems in medical device manufacturing. An ISO 13485 certificate is required for EAEU medical device registration.
GSPR (General Safety and Performance Requirements) — the general safety and performance requirements for medical devices. The manufacturer completes a compliance checklist for each applicable requirement.
Authorized representative for medical devices acts on behalf of a foreign manufacturer within the EAEU. Required for registration of foreign-manufactured devices; bears responsibility for compliance with applicable requirements.
Declaration of conformity — applies to Class 1 medical devices. The applicant self-declares conformity without involving a certification body.
Certification — applies to Classes 2a, 2b, and 3. Conducted by a certification body (notified body). Includes review of technical documentation and, where required, a manufacturing audit.
Clinical investigation of medical devices — conducted to confirm the safety and performance of higher-risk devices. The scope depends on the device class and the availability of equivalent products on the market.
Clinical evaluation — an alternative to clinical investigation for devices with existing equivalents. Involves systematic literature review and clinical data analysis for equivalent devices. Permitted when substantial equivalence with an already registered device can be demonstrated.
UDI (Unique Device Identification) — a system for uniquely identifying medical devices. Each device is assigned a unique code that allows tracing from manufacturing through use. Being implemented in the EAEU in phases.
Post-market surveillance for medical devices — systematic manufacturer activity collecting and analyzing safety and performance data for a registered device in real-world clinical practice.
Dietary Supplements, Cosmetics, and Specialty Products
This segment is governed by Customs Union Technical Regulations and national legislation. Registration is conducted by Rospotrebnadzor.
Table 11: Terms for Dietary Supplements, Cosmetics, and Specialty Products
| Term | Abbreviation | Definition |
|---|---|---|
| Dietary supplement | BAA | A product intended to supplement the diet with biologically active substances |
| State Registration Certificate | SRC | Document confirming a product’s compliance with sanitary and epidemiological requirements |
| Technical Regulation of the Customs Union | TR CU | A document establishing mandatory product requirements on EAEU territory |
| Product Information File | PIF | The dossier for a cosmetic product |
| International Nomenclature of Cosmetic Ingredients | INCI | Standardized naming system for cosmetic ingredients |
TR CU 009/2011 — the Technical Regulation «On the Safety of Perfumery and Cosmetic Products.» Defines requirements for composition, labeling, and safety assessment of cosmetics.
TR CU 021/2011 — the Technical Regulation «On the Safety of Food Products.» Covers dietary supplements as a specialized food product.
TR CU 022/2011 — the Technical Regulation «Food Products in Terms of Labeling.» Sets requirements for information on dietary supplement packaging.
ISO 22716 — the international GMP standard for cosmetics manufacturing. Describes requirements for production, quality control, storage, and dispatch of cosmetics.
Claims — marketing statements on cosmetic or dietary supplement packaging. Must be substantiated by scientific data and must not mislead consumers. Therapeutic claims for dietary supplements and cosmetics are prohibited.
Claim substantiation — the process of demonstrating that claimed product properties are accurate. For cosmetics, this may include instrumental studies (skin hydration, elasticity measurements), consumer tests, and in vitro testing.
MoS (Margin of Safety) — the safety margin for a cosmetic ingredient, calculated as the ratio of NOAEL to systemic exposure. A value above 100 is considered safe.
NOAEL (No Observed Adverse Effect Level) — the maximum dose of a substance at which no adverse effects are observed in toxicological studies.
Cosmetic safety assessment covers composition analysis, toxicological data for each ingredient, and MoS calculation. Results are compiled in a Cosmetic Product Safety Report (CPSR).
Specialized food products — products with specific properties: dietary supplements, infant nutrition, dietary products, sports nutrition. Subject to state registration with Rospotrebnadzor.
Microbiological control of cosmetics — mandatory testing of products for microorganism content. TR CU 009/2011 sets permissible levels for different cosmetic categories (children’s products, eye-area products, general use).
Veterinary Medicines
Veterinary medicine regulation in Russia is carried out by Rosselkhoznadzor under Federal Law No. 61-FZ and national regulatory acts. A separate EAEU registration procedure exists for veterinary products.
Table 12: Terms in the Veterinary Medicines Sector
| Term | Abbreviation | Definition |
|---|---|---|
| Veterinary medicinal product | VMP | A medicine for the treatment of animals |
| Maximum Residue Level | MRL | The permitted level of veterinary product residues in products of animal origin |
| Veterinary accompaniment document | — | An electronic document in the Merkury information system |
Withdrawal period — the time from the last administration of a veterinary product until food from the treated animal (meat, milk, eggs) is safe for human consumption. Specified in the label for each veterinary product.
Feed additive — added to animal feed to improve nutritional value, digestibility, or shelf life. Registered separately from veterinary medicines with Rosselkhoznadzor.
FGIS VetIS — the federal information system in veterinary affairs. Comprises subsystems: Merkury (electronic veterinary certification), Cerberus (business entity oversight), Argus (import/export permit management).
Immunobiological veterinary products — vaccines, serums, and diagnostic preparations for animals. Each batch must undergo mandatory laboratory control before release.
Disinfectants
Disinfectants in Russia are regulated as products subject to state registration with Rospotrebnadzor.
Disinfectant (biocide) — intended to destroy pathogenic microorganisms on environmental objects: surfaces, instruments, air, water.
Antiseptic — used for treating human skin and mucous membranes. Unlike disinfectants, antiseptics make direct contact with the body, so stricter safety requirements apply.
Sterilant — a chemical agent that achieves complete elimination of all microbial forms, including spores. Used for processing medical instruments and devices when steam or gas sterilization is not feasible.
Unified list of goods subject to state registration defines products requiring an SRC on Customs Union territory. Disinfectants are included in Section II of this list.
Toxicological studies evaluate substance toxicity: acute toxicity (single exposure), skin and mucous membrane irritation, and sensitizing properties. Mandatory for disinfectant registration.
Efficacy protocols confirm the bactericidal, virucidal, fungicidal, and sporicidal activity of a disinfectant. Tests are conducted by accredited laboratories using approved methodologies.
Hazard classes for disinfectants are determined by toxicological properties. Class 1 (extremely hazardous) — use restricted to specialist organizations; Class 2 (highly hazardous) — healthcare settings; Class 3 (moderately hazardous) — broader application permitted; Class 4 (low hazard) — household use.
Working solution concentration — the active substance content in the solution ready for application. Exposure time — the duration of contact between the working solution and the treated surface required to achieve the claimed effect. Both parameters are stated in the product instructions.
Classification Codes
Table 13: Key Classification Systems in the Pharmaceutical Industry
| Code | Full Name | Purpose |
|---|---|---|
| OKPD2 | All-Russian Classifier of Products by Economic Activity | Determines VAT rate and eligibility for government procurement benefits |
| TN VED EAEU | Commodity Nomenclature of Foreign Economic Activity of the EAEU | Determines customs duties, quotas, and restrictions on import/export |
| ATC | Anatomical Therapeutic Chemical classification | Used for medicine consumption statistics; assigned by the WHO |
How to Use This Glossary
Save it as a reference. When working with an unfamiliar regulatory act or document, check terms here first.
Verify context. The same term may carry different meanings in different regulatory acts. Always cross-reference the primary source.
Track updates. Regulatory terminology evolves alongside legislation. The «3+2» mechanism, for example, appeared only in 2025; the SaMD/SiMD classification is actively being shaped by AI regulation in healthcare.
Sources: Federal Law No. 61-FZ of April 12, 2010 «On the Circulation of Medicines»; Federal Law No. 323-FZ of November 21, 2011 «On the Fundamentals of Health Protection of Citizens in the Russian Federation»; EEC Council Decision No. 78 of November 3, 2016, as amended by Decisions No. 34 of May 22, 2025 and No. 77 of September 12, 2025; EEC Council Decision No. 46 of February 12, 2016; Minpromtorg Order No. 916 of June 14, 2013; Government Decree No. 1416 of December 27, 2012; TR CU 009/2011; TR CU 021/2011; TR CU 022/2011; Protocol of December 29, 2025 extending the medical device transition period to December 31, 2027.
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