Reference

Regulatory Glossary

Details: Written by: Ruslan Kuchumov; Category: Expertise; Published: 15 August 2026; Hits: 46

Regulatory terminology used across Russian and EAEU pharmaceutical regulation.

This reference is designed for international pharmaceutical manufacturers and regulatory teams. Use search, topic filters or the A–Z index; each entry has a stable link that can be opened directly from Pharegis technical articles.

A

CMC & Quality

Acceptance criterion

Numerical limit, range or other condition that must be met for a test result to comply with a specification.

Acceptance criteria translate development and stability knowledge into enforceable routine quality controls.

CMC & Quality

Active Pharmaceutical Ingredient (API)

Active substance intended to provide the pharmacological effect of a medicinal product and used in manufacture of the finished product.

API source, manufacture, controls and documentation are central to Module 3 and may trigger Russia-specific or EAEU requirements.

See also: Drug substance · Drug product · Pharmacopoeial alignment

GLP / Preclinical

ADME

Collective description of absorption, distribution, metabolism and excretion processes.

ADME understanding informs species selection, metabolite assessment and human exposure predictions.

See also: Local tolerance · Immunotoxicity · Pharmacokinetics (PK)

Lifecycle

Administrative variation

Change primarily affecting legal, administrative or descriptive dossier information rather than the scientific product basis.

Administrative changes still need controlled implementation across certificates, product information and internal master data.

Pharmacovigilance

Adverse drug reaction (ADR)

Noxious and unintended response to a medicinal product for which a causal relationship is at least a reasonable possibility.

ADR classification drives reporting, aggregate analysis, signal detection and product-information updates.

CMC & Quality

Analytical method transfer

Structured transfer of an analytical procedure from one laboratory to another with evidence that the receiving laboratory can perform it reliably.

EAEU projects can fail operationally when dossier methods are valid on paper but cannot be reproduced locally.

CMC & Quality

Analytical method validation

Documented demonstration that an analytical procedure is suitable for its intended purpose.

Validation is essential when an assessor or official laboratory must rely on the method for release or quality control.

CMC & Quality

Analytical procedure

Documented test method used to measure a quality attribute or confirm compliance with a specification.

Authorities need confidence that the method is suitable, controlled and transferable to the laboratories that may use it.

Registration

Applicant

Legal entity that submits a regulatory application or variation to the competent authority.

The applicant controls the submission, responses and procedural commitments and must match the legal role permitted by the procedure.

Medical Devices

Authorized representative

Entity authorised to act for a foreign manufacturer in the target jurisdiction for specified regulatory responsibilities.

Representative arrangements are important for applications, authority communication and post-market obligations.

B

GMP

Batch release

Formal decision that a manufactured batch meets applicable quality and regulatory requirements and may enter distribution.

Release responsibilities must align with the registered supply chain and GMP system.

Clinical / GCP

BCS-based biowaiver

Regulatory approach allowing qualifying immediate-release oral products to establish bioequivalence using BCS and dissolution evidence instead of an in vivo study.

A correct eligibility assessment can remove an unnecessary clinical study; an incorrect one can delay registration.

Clinical / GCP

Bioavailability

Rate and extent to which an active substance becomes available in the systemic circulation or at the relevant site of action.

Bioavailability concepts underpin many bioequivalence and formulation-bridging decisions.

See also: Bioequivalence · Bioequivalence study · Clinical audit

Medical Devices

Biocompatibility

Ability of device materials to perform with an appropriate biological response in the intended application.

Biocompatibility evidence must be relevant to the final device materials, processing and contact conditions.

Clinical / GCP

Bioequivalence

Absence of a clinically meaningful difference in bioavailability between comparable medicinal products under defined conditions.

Demonstrating bioequivalence is a common route to support generic registration without full efficacy trials.

Clinical / GCP

Bioequivalence study

Clinical pharmacokinetic study designed to compare the bioavailability of test and reference products.

Study design, analytical method and statistical analysis must fit the product and regulatory requirements.

See also: Reference product · Test product · Bioequivalence

Medical Devices

Biological evaluation

Risk-based assessment of biological safety of materials and device-patient contact.

It integrates material characterisation, contact type/duration and existing evidence to determine necessary testing.

Clinical / GCP

Biopharmaceutics Classification System (BCS)

Scientific framework classifying active substances by solubility and intestinal permeability for biopharmaceutic decision-making.

BCS classification can determine whether an in vivo bioequivalence study may be replaced by an in vitro biowaiver approach.

See also: BCS-based biowaiver · Dissolution profile · Test product

C

GLP / Preclinical

Carcinogenicity

Assessment of the potential of a substance to cause or promote cancer after long-term exposure.

Need and design depend on product type, duration of use, prior knowledge and applicable guidance.

GMP

Cleaning validation

Documented evidence that cleaning procedures consistently reduce residues and contaminants to acceptable levels.

It is particularly important for shared equipment, potent products and cross-contamination control.

See also: Contract manufacturing · Batch release · Qualification

Clinical / GCP

Clinical audit

Independent and systematic examination of trial activities and records against protocol, procedures and applicable requirements.

Audit provides assurance independent of routine monitoring and can identify systemic sponsor or vendor weaknesses.

See also: Bioavailability · Bioequivalence · Clinical monitoring

Medical Devices

Clinical evaluation

Systematic assessment of clinical data relevant to a medical device to verify clinical safety and performance for its intended purpose.

A credible evaluation can determine whether existing evidence is sufficient or a new clinical investigation is necessary.

Medical Devices

Clinical investigation (medical device)

Systematic investigation in human subjects undertaken to assess safety or performance of a medical device.

Investigation design must be tied directly to unresolved clinical-evidence questions and the intended claims.

Clinical / GCP

Clinical monitoring

Sponsor-supervised process for checking trial conduct, source data and protocol/GCP compliance at study sites.

Risk-based monitoring is a primary control for detecting operational problems before they become inspection findings.

Clinical / GCP

Clinical Study Report (CSR)

Integrated report describing trial design, conduct, analysis and results.

Assessors use the CSR to judge the evidentiary weight and reliability of the study.

Clinical / GCP

Clinical trial

Prospective study in human participants designed to investigate a medicinal product's effects, safety, pharmacokinetics or other clinical characteristics.

Whether new clinical evidence is required is a core registration-strategy decision.

Clinical / GCP

Clinical trial protocol

Document describing trial objectives, design, methodology, statistical considerations and operational conduct.

A protocol must be scientifically valid, operationally feasible and compatible with local regulatory expectations.

Clinical / GCP

Clinical trial site

Healthcare or research location at which trial-related activities are conducted.

Site capability affects recruitment, protocol feasibility, data quality and inspection risk.

Lifecycle

CMC change

Post-approval change affecting composition, manufacture, control, packaging or stability of a medicinal product.

A CMC change often triggers several linked variations across products, strengths, sites or markets.

Registration

Common Technical Document (CTD)

Internationally structured dossier format dividing regulatory information into administrative, summary, quality, nonclinical and clinical modules.

CTD structure is the basic architecture used to plan evidence, gaps and responsibilities across a registration project.

See also: CTD Module 1 · CTD Module 2 · Transitional case

CMC & Quality

Container-closure system

Packaging components that contain and protect a drug substance or drug product.

Packaging can affect stability, extractables/leachables, microbiological protection and change classification.

GMP

Contract manufacturing

Manufacturing activity performed by a third party under a defined technical and quality agreement.

Responsibilities can be outsourced operationally but must remain controlled within the sponsor/MAH quality system.

See also: Batch release · Critical deficiency · Cleaning validation

Clinical / GCP

Contract Research Organization (CRO)

Organisation contracted to perform one or more sponsor trial duties or functions.

Vendor selection must match the protocol, local requirements and the sponsor's oversight capability.

GMP

Corrective and Preventive Action (CAPA)

Structured action process used to correct a detected problem, address its root cause and prevent recurrence where appropriate.

Inspectors evaluate not only whether CAPAs exist but whether they are timely, evidence-based and effective.

GMP

Critical deficiency

Inspection finding representing a severe risk to product quality, patient safety or the reliability of the quality system.

A critical deficiency can threaten certification, approval and continued operation until adequately resolved.

CMC & Quality

Critical Process Parameter (CPP)

Process parameter whose variability can affect a critical quality attribute and therefore requires appropriate control.

CPP understanding helps justify operating ranges, validation strategy and change management.

CMC & Quality

Critical Quality Attribute (CQA)

Physical, chemical, biological or microbiological property that should remain within an appropriate limit or range to assure product quality.

CQAs connect development knowledge, process controls, specifications and risk management.

Registration

CTD Module 1

Region-specific administrative and prescribing-information section of the dossier.

Module 1 contains local procedural documents that often differ by jurisdiction even when the scientific dossier is global.

Registration

CTD Module 2

High-level quality, nonclinical and clinical summaries and overviews.

Module 2 must accurately reflect the underlying evidence and is often where inconsistencies between modules become visible to assessors.

See also: CTD Module 3 · CTD Module 4 · CTD Module 1

Registration

CTD Module 3

Quality section covering the drug substance, drug product, manufacture, control and stability information.

For many EAEU projects, Module 3 is the largest source of remediation work and authority questions.

See also: CTD Module 4 · CTD Module 5 · CTD Module 2

Registration

CTD Module 4

Nonclinical study reports and supporting nonclinical evidence.

Its adequacy depends on product type, prior evidence, GLP status and whether new studies are scientifically required.

See also: CTD Module 5 · Regulatory pathway · CTD Module 3

Registration

CTD Module 5

Clinical study reports and other clinical evidence supporting efficacy, safety and bioequivalence where applicable.

The acceptability of Module 5 determines whether existing global data can support EAEU registration or additional local evidence is needed.

Medical Devices

Cybersecurity (medical devices)

Protection of connected or software-enabled devices against threats that could affect safety, performance, confidentiality or availability.

Cybersecurity has become a lifecycle issue requiring design controls, vulnerability management and update governance.

D

GMP

Data integrity

Extent to which data are complete, consistent, accurate, attributable and maintained throughout their lifecycle.

Data-integrity failures can undermine otherwise acceptable testing, validation and batch records.

Registration

Decentralised Procedure (DCP)

EAEU registration route in which a medicinal product is assessed for authorisation in more than one member state without an existing EAEU authorisation serving as the starting point.

It requires a submission strategy that keeps the dossier, responses and product information aligned across participating states.

GMP

Deviation

Documented departure from an approved instruction, expected process or established standard.

Deviation handling reveals how effectively a quality system detects, investigates and controls process uncertainty.

Clinical / GCP

Dissolution profile

Measured pattern of active-substance release from a dosage form over time under defined in vitro conditions.

Dissolution comparison is central to BCS biowaivers, formulation changes and some strength-bridging strategies.

See also: Clinical trial · Sponsor · BCS-based biowaiver

CMC & Quality

Dosage form

Physical pharmaceutical form in which a medicinal product is presented and administered.

Dosage form affects registration classification, bioequivalence strategy, specifications and product information.

See also: Strength · Specification · Excipient

Lifecycle

Dossier baseline

Controlled representation of the currently approved dossier and product information against which future changes are assessed.

Without a reliable baseline, variation classification and impact assessment become guesswork.

CMC & Quality

Drug product

Finished medicinal product in its final formulation and dosage form before or after packaging as applicable.

Its manufacture, specifications, stability and packaging define the core quality basis of the marketing authorisation.

See also: Excipient · Dosage form · Drug substance

CMC & Quality

Drug substance

Active material before formulation into the finished dosage form; in many contexts equivalent to the API.

Drug-substance control strategy and manufacturing information form the substance part of Module 3.

E

Registration

EAEU common market of medicines

Common regulatory space in which medicinal products are authorised and maintained under harmonised EAEU requirements.

Portfolio strategy increasingly has to be built around EAEU authorisations rather than isolated national dossiers.

Registration

EAEU dossier alignment

Regulatory work required to bring an existing national or legacy dossier into conformity with current EAEU structure and requirements.

It is often a portfolio-remediation project rather than a simple administrative conversion.

GMP

EAEU GMP

GMP framework applied within the EAEU common medicines market under Union rules and inspection procedures.

Foreign manufacturers may need EAEU inspection planning even when they already hold certificates from other regulators.

Medical Devices

EAEU medical device registration

Union procedure for assessment and registration of medical devices under EAEU rules.

Planning must integrate classification, testing, clinical evidence, QMS and national administrative elements.

Medical Devices

Electrical safety

Assessment of electrical hazards associated with powered medical devices and systems.

Electrical-safety evidence can be a prerequisite for demonstrating basic safety and essential performance.

Medical Devices

Electromagnetic compatibility (EMC)

Ability of a device to function acceptably in its electromagnetic environment without causing unacceptable electromagnetic disturbance.

EMC testing supports safe operation in realistic clinical and home-use environments.

CMC & Quality

Elemental impurity

Trace element that may enter a medicinal product from materials, equipment, process or packaging.

Risk assessment determines which elemental impurities require control and where that control belongs in the dossier.

See also: Mutagenic impurity · Stability study · Residual solvent

Clinical / GCP

Ethics Committee

Independent body that reviews ethical acceptability and participant-protection aspects of a clinical study.

Ethics review is a separate control layer from regulatory authorisation and must be planned in the study timeline.

Registration

Eurasian Economic Commission (EEC)

Permanent regulatory body of the EAEU that adopts and maintains many of the acts governing the common markets for medicines and medical devices.

Its decisions and guidance form the primary regulatory rule set used when planning EAEU submissions.

Registration

Eurasian Economic Union (EAEU)

Regional economic union whose common pharmaceutical framework underpins EAEU procedures for medicinal products and medical devices.

It determines which supranational rules, procedures and mutual-recognition mechanisms apply across member states.

CMC & Quality

Excipient

Inactive formulation component used to enable manufacture, stability, delivery, appearance or performance of the drug product.

Excipient differences can affect quality and, for some bioequivalence or biowaiver strategies, absorption risk.

See also: Dosage form · Strength · Drug product

F

Clinical / GCP

Foreign clinical study

Clinical study conducted outside the target EAEU jurisdiction and proposed as evidence in the registration dossier.

Its acceptability depends on relevance, GCP credibility, population considerations and the regulatory route.

G

Clinical / GCP

GCP inspection

Regulatory inspection evaluating compliance of a clinical trial, site, sponsor or vendor with GCP and the reliability of submitted data.

For foreign evidence, inspection strategy may determine whether existing studies can be accepted without repeating the trial locally.

GLP / Preclinical

Genotoxicity

Assessment of a substance's potential to damage genetic material.

Positive or uncertain genotoxic findings can materially alter development, impurity controls and clinical risk management.

GMP

GMP certificate

Formal document confirming that the inspected manufacturing operations comply with applicable GMP requirements within the stated scope.

The certificate must cover the sites, dosage forms and operations relevant to the registration and supply strategy.

See also: GMP inspection · Pharmaceutical inspectorate · EAEU GMP

GMP

GMP inspection

Regulatory inspection of a manufacturing site and quality system against applicable GMP requirements.

Inspection outcome can directly affect registration timing, supply continuity and the acceptability of a manufacturing site.

Clinical / GCP

Good Clinical Practice (GCP)

International ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials involving humans.

GCP compliance protects participants and supports regulatory credibility of trial data.

See also: GCP inspection · Local clinical study · Ethics Committee

GLP / Preclinical

Good Laboratory Practice (GLP)

Quality system governing organisation, conduct, recording, reporting and archiving of regulated nonclinical safety studies.

GLP status supports the traceability and regulatory reliability of pivotal nonclinical safety data.

GMP

Good Manufacturing Practice (GMP)

Quality framework requiring medicinal products and active substances to be consistently produced and controlled to standards appropriate for their intended use.

GMP status supports trust in the manufacturing data and is a core prerequisite for market supply.

See also: EAEU GMP · GMP certificate · Major deficiency

Pharmacovigilance

Good Pharmacovigilance Practice (GVP)

Rules and quality principles governing pharmacovigilance systems and activities.

EAEU GVP requirements shape system design, reporting, signal management, risk management and inspection readiness.

Lifecycle

Grouping of variations

Submission strategy in which eligible related variations are combined in one regulatory application or coordinated package.

Good grouping reduces procedural fragmentation while poor grouping can make a submission inadmissible or harder to assess.

I

Lifecycle

IA_NU variation

Type IA notification route used for specified minor changes that do not require prior approval before implementation under the applicable EAEU rules.

Teams need a controlled notification process so implementation timing remains consistent with the legal classification.

See also: Type IB variation · Type II variation · Type IA variation

GLP / Preclinical

Immunotoxicity

Assessment of adverse effects on immune-system structure or function.

Biologics and immune-active products may require focused evaluation beyond general toxicity studies.

CMC & Quality

Impurity

Chemical or biological component present in a substance or product that is not the intended active or formulation component.

Impurity control is a recurring focus of specifications, method capability, qualification and stability assessment.

Medical Devices

In vitro diagnostic medical device (IVD)

Medical device intended to examine specimens derived from the human body to provide diagnostic or related information.

IVDs follow device-specific classification and performance-evidence pathways rather than medicinal-product rules.

GLP / Preclinical

In vitro study

Study performed outside a living organism using cells, tissues, biochemical systems or other laboratory models.

In vitro methods are increasingly important for mechanistic evidence, screening and reduction of unnecessary animal use.

GLP / Preclinical

In vivo study

Study performed in a living organism.

In vivo evidence remains necessary where whole-organism exposure, toxicity or pharmacology cannot be adequately addressed by other methods.

Pharmacovigilance

Individual Case Safety Report (ICSR)

Structured report of an individual suspected adverse reaction or other reportable safety case.

Timely, complete case processing is a core operational pharmacovigilance obligation.

GMP

Inspection readiness

State in which the site, documentation, personnel and systems can demonstrate sustained GMP compliance under inspection.

Readiness work should reproduce how inspectors test evidence rather than merely prepare presentation materials.

GMP

Inspection scope

Manufacturing operations, dosage forms, systems and areas covered by a particular inspection.

A certificate outside the required scope may not satisfy the registration need even if the site has been inspected.

Medical Devices

Instructions for Use (IFU)

Manufacturer-provided information describing intended use, operation, warnings, precautions and other information needed for safe and effective device use.

IFU content must match the registered intended purpose, evidence and risk controls.

Medical Devices

Intended purpose

Use for which the manufacturer designs and represents a medical device in labelling, instructions and technical documentation.

Intended purpose drives classification, evidence requirements, claims and the scope of regulatory review.

Clinical / GCP

Investigator's Brochure (IB)

Compilation of clinical and nonclinical information relevant to study of an investigational medicinal product in humans.

It supports investigator understanding, risk assessment and protocol conduct.

Medical Devices

ISO 13485

International standard specifying quality-management-system requirements for medical-device organisations.

It is widely used as the structural basis for manufacturer QMS evidence, though regulatory obligations remain jurisdiction-specific.

L

Lifecycle

Labeling

Text and information presented on immediate and outer packaging and other approved product labels.

Labeling is a registered control surface and must match the authorised product, local language and product information.

Lifecycle

Lifecycle management

Coordinated regulatory control of changes, renewals, commitments, product information and compliance after initial approval.

A lifecycle system prevents local changes from drifting away from the approved dossier or from each other across markets.

Pharmacovigilance

Literature monitoring

Systematic surveillance of scientific and medical literature for reportable safety information and emerging evidence.

Literature is a continuing source of ICSRs and signals and must be covered by documented processes.

Clinical / GCP

Local clinical study

Clinical study conducted in the target jurisdiction or using local sites to satisfy scientific or regulatory needs.

A local study may be necessary when existing foreign evidence does not adequately support the EAEU registration case.

Lifecycle

Local language version

Approved translation or local-language rendering of regulatory product information.

Translation must preserve scientific meaning while meeting local terminology, readability and formatting expectations.

Pharmacovigilance

Local safety contact

Locally available pharmacovigilance contact function used where national or operational requirements require in-country accessibility.

It bridges central safety governance with local reporting channels and authority communication.

GLP / Preclinical

Local tolerance

Assessment of adverse effects at the site of administration or contact.

It may be particularly relevant for injectable, topical, inhaled or other locally acting products.

M

GMP

Major deficiency

Serious GMP deficiency that may significantly affect product quality or demonstrates a substantial weakness in the quality system.

Clusters of major findings can indicate systemic non-compliance and require robust CAPA evidence.

CMC & Quality

Manufacturing process

Defined sequence of operations used to produce the drug substance or drug product.

The approved process is part of the registered quality basis; meaningful changes require regulatory impact assessment.

GMP

Manufacturing site

Geographically defined facility at which one or more manufacturing, testing, packaging or release operations are performed.

Every site and activity must be correctly represented across the dossier, GMP scope and supply chain.

Lifecycle

Manufacturing site change

Addition, replacement, removal or change in role of a site involved in manufacture, testing, packaging or release.

Site changes must be aligned with dossier evidence, GMP status, supply-chain qualification and implementation timing.

See also: Shelf-life extension · Variation · CMC change

Registration

Marketing authorization (MA)

Regulatory authorisation allowing a medicinal product to be placed on the relevant market subject to its approved dossier and product information.

The MA defines the approved product, manufacturing and clinical basis that later variations must maintain.

Registration

Marketing Authorization Holder (MAH)

Legal entity that holds the marketing authorisation and carries continuing responsibility for the authorised medicinal product.

The MAH is the focal point for lifecycle, pharmacovigilance, product-information and compliance obligations.

Medical Devices

Medical device

Instrument, apparatus, software, implant, material or other product intended for a medical purpose whose principal intended action is not achieved by pharmacological, immunological or metabolic means.

Correct qualification as a medical device is the starting point for the entire registration pathway.

Medical Devices

Medical device manufacturer

Legal entity responsible for design, manufacture and placing the device on the market under its name or trademark.

Manufacturer identity anchors technical-documentation, QMS and post-market responsibilities.

Medical Devices

Medical device registration dossier

Structured set of administrative, technical, safety, performance and quality-system documentation submitted for device registration.

A coherent dossier must link intended purpose, design, risk management and evidence without contradictions.

Lifecycle

Mock-up

Graphic representation of final packaging or leaflet layout submitted to demonstrate how approved information will appear in use.

Mock-ups reveal space, readability and consistency problems that text-only review may miss.

CMC & Quality

Mutagenic impurity

Impurity with actual or potential DNA-reactive mutagenic properties requiring risk-based assessment and control.

Even very low levels may drive additional analytical sensitivity, process controls and regulatory justification.

See also: Stability study · Shelf life · Elemental impurity

Registration

Mutual Recognition Procedure (MRP)

Procedure in which an existing assessment or authorisation in the Reference State is used as the basis for recognition by additional EAEU member states.

It is a common expansion route for extending an authorised product into additional EAEU markets.

N

Registration

National registration procedure

Country-specific registration route governed by national law rather than the EAEU common procedure.

Legacy national products may require transition, alignment or replacement by EAEU-compliant authorisations.

GLP / Preclinical

Nonclinical comparability for biologics/biosimilars

Stepwise comparison of biological products using analytical and nonclinical evidence to characterise similarity and residual uncertainty.

Well-designed comparability can reduce unnecessary animal studies while identifying where targeted evidence is still needed.

See also: In vitro study · In vivo study · Immunotoxicity

O

GMP

Out-of-Specification (OOS) result

Test result falling outside an approved specification or acceptance criterion.

OOS investigations are a high-visibility indicator of laboratory governance, data integrity and batch disposition controls.

See also: Data integrity · Qualification · Deviation

P

Lifecycle

Patient Information Leaflet / Package Leaflet (PIL)

Regulator-approved information for patients or users explaining safe and effective use of the medicinal product.

PIL language must translate the approved medical content into clear, usable patient-facing information.

Medical Devices

Performance evaluation (IVD)

Assessment of scientific validity, analytical performance and clinical performance of an IVD as applicable.

The performance package must support the claimed analyte, specimen, population and intended diagnostic use.

Pharmacovigilance

Periodic Safety Update Report / PBRER

Periodic aggregate safety report evaluating worldwide safety information and the evolving benefit-risk balance of an authorised product.

It provides regulators with a structured longitudinal assessment beyond individual case reports.

GMP

Pharmaceutical inspectorate

Competent inspection body responsible for conducting pharmaceutical inspections and issuing inspection conclusions or certificates.

Understanding inspectorate jurisdiction and workflow is necessary for realistic inspection planning.

GMP

Pharmaceutical Quality System (PQS)

Management system integrating quality governance, responsibilities, processes, monitoring and continual improvement across pharmaceutical manufacture.

A weak PQS turns isolated observations into systemic inspection risk.

GLP / Preclinical

Pharmacokinetics (PK)

Study of absorption, distribution, metabolism and excretion of a substance over time.

PK connects dose to systemic exposure and supports both nonclinical and clinical interpretation.

See also: ADME · Local tolerance · Toxicokinetics

CMC & Quality

Pharmacopoeial alignment

Process of reconciling dossier specifications and methods with applicable EAEU and national pharmacopoeial requirements.

Unresolved pharmacopoeial gaps can block approval, official testing or later lifecycle changes even when the global dossier is scientifically sound.

CMC & Quality

Pharmacopoeial reference standard

Official or compendial reference material established for use with a pharmacopoeial method.

When a pharmacopoeial method is mandatory, the corresponding official standard may also become operationally necessary.

See also: Impurity · Residual solvent · Reference standard

Pharmacovigilance

Science and activities relating to detection, assessment, understanding and prevention of adverse effects or other medicine-related problems.

An MAH needs a functioning pharmacovigilance system from market entry through the full product lifecycle.

Pharmacovigilance

Pharmacovigilance inspection

Regulatory inspection of an MAH's pharmacovigilance system, activities, records and compliance.

Inspection readiness requires evidence that governance works across the MAH, QPPV and outsourced vendors.

Pharmacovigilance

Pharmacovigilance system

Organised structure, processes, resources and data used by an MAH to fulfil pharmacovigilance obligations.

The system must work as an integrated control environment rather than as disconnected vendor tasks.

Pharmacovigilance

Pharmacovigilance System Master File (PSMF)

Controlled document describing the pharmacovigilance system, its organisation, processes, data sources and quality controls.

The PSMF is a key inspection document and should describe the real operating system, not an aspirational model.

Pharmacovigilance

Pharmacovigilance vendor oversight

Sponsor/MAH governance of outsourced safety activities through qualification, agreements, metrics, review and escalation.

Outsourcing execution does not outsource regulatory accountability.

Lifecycle

Post-approval commitment

Study, data submission, action or other obligation agreed or imposed as a condition of or following authorisation.

Commitments need formal tracking because missed dates can create compliance and lifecycle risk.

Pharmacovigilance

Post-Authorization Safety Study (PASS)

Study performed after authorisation to further characterise, quantify or evaluate a safety concern or the effectiveness of risk minimisation.

PASS commitments may become an important component of an RMP or authority request.

Medical Devices

Post-market surveillance (medical devices)

Systematic collection and review of information on device performance and safety after market placement.

Post-market data feed complaints, vigilance, risk management and decisions on corrective action or design changes.

GLP / Preclinical

Preclinical / nonclinical study

Laboratory or animal study conducted before or alongside clinical development to characterise pharmacology, toxicology and other nonclinical risks.

The key registration question is not whether studies exist, but whether the evidence package answers the product-specific safety questions.

Clinical / GCP

Principal Investigator (PI)

Investigator responsible for conduct of a clinical trial at a study site.

Site quality, protocol compliance and source-data credibility depend heavily on PI leadership and oversight.

CMC & Quality

Process validation

Documented evidence that a manufacturing process can reproducibly deliver product meeting predefined quality requirements.

Validation status is scrutinised both in dossier assessment and GMP inspection.

Lifecycle

Product information harmonisation

Process of aligning SmPC, PIL and labeling content across EAEU member states and related submissions.

Harmonisation reduces contradictory local texts and simplifies later lifecycle maintenance.

Q

GMP

Qualification

Documented demonstration that premises, utilities, equipment or systems are properly installed and operate as intended.

Qualification provides the controlled foundation on which validated processes and testing depend.

Pharmacovigilance

Qualified Person for Pharmacovigilance (QPPV)

Designated pharmacovigilance professional with defined responsibility and oversight for the pharmacovigilance system.

Role design, access to information and vendor governance must allow the QPPV to exercise effective oversight.

CMC & Quality

Quality Document (ND / normative document)

Russia/EAEU-oriented quality-control document translating the approved quality standard into an operational specification and method package for regulatory use.

It is where global CMC documentation must become practically executable under local pharmacopoeial and official-testing expectations.

Medical Devices

Quality Management System (QMS)

Organisational system for defining and controlling processes that affect medical-device quality and compliance.

QMS maturity supports consistent manufacture, change control, complaints and post-market surveillance.

See also: ISO 13485 · Clinical evaluation · Technical documentation

Lifecycle

Quality variation

Lifecycle change affecting Module 3, manufacture, controls, materials, packaging, stability or another CMC element.

Quality variations frequently interact with GMP scope, pharmacopoeial requirements and supply-chain implementation.

R

Lifecycle

Readability / user testing

Evaluation of whether target users can find and understand important information in a package leaflet or other product-information format.

Poor readability can become a regulatory and patient-safety issue even when the underlying wording is technically correct.

Registration

Recognition State

EAEU member state that relies on and recognises the assessment performed by the Reference State in the applicable procedure.

Recognition-state requirements must be anticipated when harmonising product information and national administrative elements.

Clinical / GCP

Reference product

Authorised medicinal product selected as the comparator for a bioequivalence or other comparative development program.

Using an unacceptable comparator can invalidate an otherwise technically sound study.

CMC & Quality

Reference standard

Well-characterised material used as a benchmark for identity, purity, potency or quantitative testing.

Reference-standard availability and traceability directly affect routine testing and official quality control.

Registration

Reference State

EAEU member state that performs the principal assessment of a medicinal-product dossier in the applicable EAEU procedure.

Choice and readiness of the Reference State affect assessment flow, questions and coordination with other participating states.

Registration

Registration certificate

Official document confirming that a medicinal product or medical device has been registered under the applicable procedure.

It is the formal evidence of authorisation and links the approved product to its legal holder and registration data.

Registration

Registration dossier

Structured set of administrative, quality, nonclinical and clinical documentation submitted to support authorisation of a product.

Its completeness and internal consistency drive both approval risk and the workload required for authority questions.

Lifecycle

Regulatory impact assessment

Structured evaluation of how a proposed business, manufacturing, quality or safety change affects registrations and regulatory obligations.

It should happen before implementation decisions so regulatory constraints can shape the change plan.

Registration

Regulatory pathway

Defined procedural route by which a product is registered, changed, renewed or otherwise maintained.

Pathway selection controls evidence requirements, sequence, authority interactions and project timing.

Lifecycle

Renewal

Procedure for continuation of a marketing authorisation where renewal is required by the applicable framework.

Renewal strategy should be integrated with outstanding commitments, safety status and pending lifecycle changes.

GLP / Preclinical

Repeat-dose toxicity

Study evaluating toxic effects after repeated administration over a defined period.

It helps identify target organs, exposure relationships and reversibility relevant to intended clinical use.

See also: Genotoxicity · Carcinogenicity · Toxicology

GLP / Preclinical

Reproductive and developmental toxicity

Assessment of potential effects on fertility, pregnancy, embryo-fetal development and postnatal development.

These data support risk assessment, labelling and use in populations of reproductive potential.

See also: Safety pharmacology · Toxicokinetics · Carcinogenicity

CMC & Quality

Residual solvent

Organic volatile chemical remaining from manufacture or purification of a substance or product.

Residual-solvent limits must be justified and controlled in a way consistent with process capability and applicable guidance.

See also: Elemental impurity · Mutagenic impurity · Impurity

CMC & Quality

Retest period

Period during which a drug substance is expected to remain within specification and after which it should be retested before use.

It is particularly important for API lifecycle management and incoming-material control.

Medical Devices

Risk classification

Assignment of a medical device to a risk class based on intended purpose, invasiveness, duration, active characteristics and other classification rules.

Risk class strongly influences the depth of evidence and conformity/registration requirements.

Pharmacovigilance

Risk Management Plan (RMP)

Structured document describing important safety concerns, pharmacovigilance activities and risk-minimisation measures for a medicinal product.

The RMP links known and potential risks to concrete actions and must remain aligned with emerging safety information.

Pharmacovigilance

Risk-minimisation measure

Intervention intended to prevent or reduce the occurrence, severity or impact of an adverse reaction.

Risk-minimisation measures must be practical, measurable and reflected consistently in product information and implementation materials.

S

Pharmacovigilance

Safety Data Exchange Agreement (SDEA)

Agreement defining pharmacovigilance information-exchange responsibilities between business partners.

Clear SDEA rules prevent missed cases, duplicate reporting and ambiguity over timelines or ownership.

Pharmacovigilance

Safety database

Validated system used to receive, process, store, analyse and report pharmacovigilance cases and related safety data.

Database configuration and governance affect compliance, traceability and inspection readiness.

GLP / Preclinical

Safety pharmacology

Studies examining undesirable pharmacodynamic effects on vital physiological functions.

Cardiovascular, respiratory and central-nervous-system risks are common focus areas.

Pharmacovigilance

Safety signal

Information suggesting a new potentially causal association, or a new aspect of a known association, that warrants further investigation.

Signal handling converts dispersed safety observations into regulatory decisions and risk-management actions.

Pharmacovigilance

Safety specification

RMP section summarising important identified risks, important potential risks and missing information as applicable.

It defines which uncertainties and safety concerns the pharmacovigilance plan must actively address.

Lifecycle

Safety/efficacy variation

Lifecycle change driven by new clinical, safety or efficacy information.

It may require updated SmPC/PIL text, RMP changes and coordinated pharmacovigilance implementation.

See also: Urgent safety restriction · Renewal · Quality variation

Pharmacovigilance

Serious adverse reaction

Adverse reaction meeting seriousness criteria such as death, life-threatening outcome, hospitalisation, disability or other medically important consequences.

Seriousness affects expedited reporting and prioritisation of medical assessment.

CMC & Quality

Shelf life

Approved period during which the medicinal product is expected to remain within specification when stored as labelled.

Shelf life is a registered attribute and extensions normally require supporting stability evidence.

See also: Retest period · Storage conditions · Stability study

Lifecycle

Shelf-life extension

Post-approval increase in the authorised shelf life based on additional stability data and supporting justification.

The regulatory change must be approved or notified as required before the longer shelf life is used commercially.

See also: Variation · Type IA variation · Manufacturing site change

Pharmacovigilance

Signal management

Structured process for signal detection, validation, confirmation, analysis, prioritisation, assessment and recommendation for action.

Weak signal governance can delay recognition of a meaningful new safety risk.

GMP

Site Master File (SMF)

Concise document describing a manufacturing site's quality system, activities, premises, equipment and key GMP arrangements.

A current SMF is a central inspection document and should be consistent with the actual site and dossier.

Medical Devices

Software as a Medical Device (SaMD)

Software intended for one or more medical purposes that performs those purposes without being part of a hardware medical device.

SaMD requires software lifecycle, clinical/performance, cybersecurity and change-control evidence proportionate to risk.

CMC & Quality

Specification

List of tests, analytical procedures and acceptance criteria defining the required quality of a material or product.

A usable EAEU specification must be scientifically justified and aligned with applicable pharmacopoeial requirements.

See also: Analytical procedure · Acceptance criterion · Strength

CMC & Quality

Stability study

Study evaluating how product or substance quality changes with time under defined environmental conditions.

Stability data justify shelf life, retest period, storage conditions and some post-approval changes.

See also: Shelf life · Retest period · Mutagenic impurity

CMC & Quality

Storage conditions

Approved environmental conditions under which a substance or product must be stored.

Storage wording must be supported by stability data and kept consistent across dossier, label and product information.

CMC & Quality

Strength

Amount or concentration of active substance associated with a unit of the medicinal product.

Strength determines dossier scope, study bridging, product-information wording and lifecycle grouping.

See also: Specification · Analytical procedure · Dosage form

Lifecycle

Summary of Product Characteristics (SmPC)

Regulator-approved professional product information describing indications, dosing, contraindications, warnings, adverse reactions and other prescribing information.

SmPC wording must remain consistent with the evidence, RMP and corresponding patient information.

T

Medical Devices

Technical documentation

Manufacturer-controlled documentation describing device design, manufacture, specifications, risk management, verification, validation and intended use.

It provides the core evidence that the device has been designed and controlled to meet applicable requirements.

Clinical / GCP

Test product

Investigational or proposed generic product compared with the reference product in a bioequivalence study.

Its formulation, batch and manufacturing scale must appropriately represent the product to be registered.

GLP / Preclinical

Toxicokinetics

Measurement of systemic exposure during toxicity studies to relate administered dose to observed toxic effects.

Exposure data make animal toxicity findings interpretable for human risk assessment.

See also: Pharmacokinetics (PK) · ADME · Safety pharmacology

GLP / Preclinical

Toxicology

Study of adverse effects of a substance and the relationship between exposure and harmful biological responses.

The toxicology program defines key safety margins and risks carried into clinical development and product information.

Lifecycle

Transfer of marketing authorization

Regulatory process changing the legal holder of an existing marketing authorisation.

Transfer affects pharmacovigilance, product information, agreements, supply chain and regulatory master data simultaneously.

See also: Post-approval commitment · Lifecycle management · Renewal

Registration

Transitional case

Product or procedure that remains subject to transitional provisions while moving from national rules to the EAEU framework.

Correct classification of a transitional case determines the legal route, timing and amount of dossier remediation required.

Lifecycle

Type IA variation

Minor variation with limited potential impact that is handled through the simplified EAEU lifecycle route specified for Type IA changes.

Misclassifying a change as IA can create compliance risk if prior assessment was actually required.

See also: IA_NU variation · Type IB variation · Variation

Lifecycle

Type IB variation

Variation of moderate regulatory significance that requires assessment under the Type IB procedure.

IB changes often need concise but complete justification and careful sequencing with implementation.

Lifecycle

Type II variation

Major variation with potentially significant impact on quality, safety or efficacy and therefore a higher assessment burden.

Type II planning should begin early because evidence, review and implementation timelines are materially greater.

U

Pharmacovigilance

Unexpected adverse reaction

Adverse reaction whose nature, severity or outcome is not consistent with the applicable reference safety information.

Unexpectedness is important for expedited reporting and emerging-signal assessment.

Lifecycle

Urgent safety restriction

Temporary or immediate safety-related measure introduced to protect patients while a formal regulatory change is processed.

Governance must allow rapid action without losing control of the subsequent variation and communication package.

V

Lifecycle

Variation

Post-authorisation change to the approved dossier, product information, manufacturing arrangements or other registered particulars.

Correct classification determines documentation, approval route, timing and whether changes may be grouped.