INOPP Forum
Pharmacovigilance Requirements in Azerbaijan
Quote from VigiServe Admin on November 29, 2020, 5:56 AMThe pharmacovigilance (PV) system in Azerbaijan is moderately developed and increasingly harmonized with international standards (e.g., WHO and elements of EU GVP), particularly since reforms around 2019–2024. Azerbaijan joined the WHO Programme for International Drug Monitoring (PIDM) in 2018, contributing Individual Case Safety Reports (ICSRs) to VigiBase via VigiFlow. The system focuses on post-marketing surveillance, adverse reaction monitoring, and risk management, with active promotion through WHO/UMC collaboration (e.g., web-based tools for signal detection).
Legal Framework and Governance
- Primary authority: Analytical Expertise Center (AEC) under the Ministry of Health (also referred to as the Center for Analytical Expertise of Medicines or similar; official site: pharma.az or aem.az).
- Key regulations:
- Law of the Republic of Azerbaijan “On Medicinal Products” (primary law).
- Cabinet of Ministers Resolution No. 503 (2019): “Regulations of the Pharmacovigilance of Medicinal Products” (detailed framework for PV activities).
- Guidelines for Good Pharmacovigilance Practice (approved, with English translations available; harmonized concepts and requirements).
- National Pharmacovigilance Center operates within AEC for ADR collection, signal detection, risk evaluation, inspections, audits, and regulatory actions (e.g., alerts, label changes, recalls).
Organization and Personnel
- Marketing Authorization Holders (MAHs) must establish and maintain a PV system compliant with national regulations and guidelines.
- Local Qualified Person for Pharmacovigilance (QPPV) / Local Contact Person for Pharmacovigilance (LCPPV): Not strictly mandatory by law in all cases, but often required in practice (e.g., authorities may request a local resident QPPV or contact person in the registration dossier for foreign applicants; serves as primary authority contact).
- No formal PV System Master File (PSMF) registration/location mandate is detailed publicly, but PV procedures/system descriptions must be documented and available (e.g., during inspections).
Individual Case Safety Reports (ICSRs) – Post-Marketing
- Suspected ADRs, medication errors, quality issues, or interactions reported by HCPs, patients, or MAHs to the National Pharmacovigilance Center (AEC).
- Timelines (per Resolution No. 503 and guidelines):
- Serious adverse events (domestic): Reported within 15 calendar days of receipt.
- Non-serious or foreign cases: Included in periodic reports or as required.
- Reports use standard formats (aligned with ICH E2B where applicable); spontaneous reporting encouraged.
Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)
- MAHs submit periodic safety update reports (PSURs/PBRERs) as required (aligned with basic ICH E2C-like formats in GVP guidelines).
- Frequency: Not rigidly standardized publicly (e.g., no mandatory 6-monthly/annual cycle for all); typically during registration renewals, variations, or on request/safety concerns.
Risk Management Plans (RMP)
- Not mandatory for all products; required or requested for high-risk/new substances, biologics, or specific concerns (per GVP guidelines and signal-based decisions).
Signal Management and Emerging Safety Issues
- AEC conducts ongoing surveillance, signal detection, and risk assessment (using UMC tools).
- MAHs monitor data and notify validated signals or major emerging issues (e.g., new risks, foreign actions) promptly (no fixed 5–45 day timelines publicly detailed beyond general promptness).
Clinical Trials-Related Safety Requirements Clinical trials are regulated by the Ministry of Health/AEC, with authorization required. The PV framework applies broadly, but specific trial guidelines reference international norms.
- Sponsors must monitor safety and report serious adverse events/SAEs.
- Suspected Unexpected Serious Adverse Reactions (SUSARs) reported expeditiously to AEC (aligned with ICH E2A principles).
- Timelines: Expedited for serious unexpected events (typically 7–15 days, with faster for fatal/life-threatening; often 15 days for serious per post-marketing analogy, though trial-specific approvals may specify).
- No dedicated national electronic system highlighted (e.g., no EudraVigilance access); reports submitted directly to AEC (forms/email).
- Periodic safety reporting: Development Safety Update Reports (DSURs) or annual updates may be required/requested, following ICH E2F formats, especially for ongoing/multi-country trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to authorities/ethics committees.
Additional Monitoring / Other Aspects
- No black triangle/additional monitoring scheme mentioned.
- Emphasis on quality monitoring, counterfeit detection, and public health programs.
- Inspections/audits by AEC possible; ADR reporting improving with training and tools, though volumes may be moderate.
Azerbaijan's PV framework is practical and WHO-aligned, with growing harmonization (e.g., via GVP guidelines and UMC support) — more structured than many CIS neighbors but less prescriptive than full EU/ICH systems (e.g., no universal routine PSUR cycles or strict local QPPV mandates in all scenarios). It balances MAH obligations with national surveillance.
For precise, product- or trial-specific details (e.g., latest timelines/forms from Resolution No. 503 or GVP guidelines), consult the Analytical Expertise Center directly via pharma.az (or aem.az), Ministry of Health channels, or official contacts, as requirements evolve (notably post-2019 reforms and ongoing updates). Companies often use local consultants or align with WHO/ICH for compliance in Azerbaijan.
E-Mail: adr@pharma.az
Fax: (99412) 596-07-16
REPORTING THROUGH POST:
Azərbaycan Respublikası Səhiyyə Nazirliyi Analitik Ekspertiza Mərkəzi
Farmakonəzarət Sektoru
AZ1065, Azərbaycan Respublikası; Bakı şəh.,
C.Cabbarlı küç., 34.
Azerbaijan Republic Ministry of Health Analytical Expertise Center Pharmacovigilance sectorAZ1065, Azerbaijan Republic; Baku.,J.Jabbarli street.,34
Tel: (99412) 596-05-20
Hotline: (99412) 596-07-12
The pharmacovigilance (PV) system in Azerbaijan is moderately developed and increasingly harmonized with international standards (e.g., WHO and elements of EU GVP), particularly since reforms around 2019–2024. Azerbaijan joined the WHO Programme for International Drug Monitoring (PIDM) in 2018, contributing Individual Case Safety Reports (ICSRs) to VigiBase via VigiFlow. The system focuses on post-marketing surveillance, adverse reaction monitoring, and risk management, with active promotion through WHO/UMC collaboration (e.g., web-based tools for signal detection).
Legal Framework and Governance
- Primary authority: Analytical Expertise Center (AEC) under the Ministry of Health (also referred to as the Center for Analytical Expertise of Medicines or similar; official site: pharma.az or aem.az).
- Key regulations:
- Law of the Republic of Azerbaijan “On Medicinal Products” (primary law).
- Cabinet of Ministers Resolution No. 503 (2019): “Regulations of the Pharmacovigilance of Medicinal Products” (detailed framework for PV activities).
- Guidelines for Good Pharmacovigilance Practice (approved, with English translations available; harmonized concepts and requirements).
- National Pharmacovigilance Center operates within AEC for ADR collection, signal detection, risk evaluation, inspections, audits, and regulatory actions (e.g., alerts, label changes, recalls).
Organization and Personnel
- Marketing Authorization Holders (MAHs) must establish and maintain a PV system compliant with national regulations and guidelines.
- Local Qualified Person for Pharmacovigilance (QPPV) / Local Contact Person for Pharmacovigilance (LCPPV): Not strictly mandatory by law in all cases, but often required in practice (e.g., authorities may request a local resident QPPV or contact person in the registration dossier for foreign applicants; serves as primary authority contact).
- No formal PV System Master File (PSMF) registration/location mandate is detailed publicly, but PV procedures/system descriptions must be documented and available (e.g., during inspections).
Individual Case Safety Reports (ICSRs) – Post-Marketing
- Suspected ADRs, medication errors, quality issues, or interactions reported by HCPs, patients, or MAHs to the National Pharmacovigilance Center (AEC).
- Timelines (per Resolution No. 503 and guidelines):
- Serious adverse events (domestic): Reported within 15 calendar days of receipt.
- Non-serious or foreign cases: Included in periodic reports or as required.
- Reports use standard formats (aligned with ICH E2B where applicable); spontaneous reporting encouraged.
Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)
- MAHs submit periodic safety update reports (PSURs/PBRERs) as required (aligned with basic ICH E2C-like formats in GVP guidelines).
- Frequency: Not rigidly standardized publicly (e.g., no mandatory 6-monthly/annual cycle for all); typically during registration renewals, variations, or on request/safety concerns.
Risk Management Plans (RMP)
- Not mandatory for all products; required or requested for high-risk/new substances, biologics, or specific concerns (per GVP guidelines and signal-based decisions).
Signal Management and Emerging Safety Issues
- AEC conducts ongoing surveillance, signal detection, and risk assessment (using UMC tools).
- MAHs monitor data and notify validated signals or major emerging issues (e.g., new risks, foreign actions) promptly (no fixed 5–45 day timelines publicly detailed beyond general promptness).
Clinical Trials-Related Safety Requirements Clinical trials are regulated by the Ministry of Health/AEC, with authorization required. The PV framework applies broadly, but specific trial guidelines reference international norms.
- Sponsors must monitor safety and report serious adverse events/SAEs.
- Suspected Unexpected Serious Adverse Reactions (SUSARs) reported expeditiously to AEC (aligned with ICH E2A principles).
- Timelines: Expedited for serious unexpected events (typically 7–15 days, with faster for fatal/life-threatening; often 15 days for serious per post-marketing analogy, though trial-specific approvals may specify).
- No dedicated national electronic system highlighted (e.g., no EudraVigilance access); reports submitted directly to AEC (forms/email).
- Periodic safety reporting: Development Safety Update Reports (DSURs) or annual updates may be required/requested, following ICH E2F formats, especially for ongoing/multi-country trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to authorities/ethics committees.
Additional Monitoring / Other Aspects
- No black triangle/additional monitoring scheme mentioned.
- Emphasis on quality monitoring, counterfeit detection, and public health programs.
- Inspections/audits by AEC possible; ADR reporting improving with training and tools, though volumes may be moderate.
Azerbaijan's PV framework is practical and WHO-aligned, with growing harmonization (e.g., via GVP guidelines and UMC support) — more structured than many CIS neighbors but less prescriptive than full EU/ICH systems (e.g., no universal routine PSUR cycles or strict local QPPV mandates in all scenarios). It balances MAH obligations with national surveillance.
For precise, product- or trial-specific details (e.g., latest timelines/forms from Resolution No. 503 or GVP guidelines), consult the Analytical Expertise Center directly via pharma.az (or aem.az), Ministry of Health channels, or official contacts, as requirements evolve (notably post-2019 reforms and ongoing updates). Companies often use local consultants or align with WHO/ICH for compliance in Azerbaijan.
E-Mail: adr@pharma.az
Fax: (99412) 596-07-16
REPORTING THROUGH POST:
Azərbaycan Respublikası Səhiyyə Nazirliyi Analitik Ekspertiza Mərkəzi
Farmakonəzarət Sektoru
AZ1065, Azərbaycan Respublikası; Bakı şəh.,
C.Cabbarlı küç., 34.
Azerbaijan Republic Ministry of Health Analytical Expertise Center Pharmacovigilance sectorAZ1065, Azerbaijan Republic; Baku.,J.Jabbarli street.,34
Tel: (99412) 596-05-20
Hotline: (99412) 596-07-12
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