Quote from VigiServe Admin on November 28, 2020, 6:04 AM

The pharmacovigilance (PV) system in **Iran** is functional and moderately mature, aligned with **WHO** minimum standards and contributing to VigiBase since Iran became a full WHO Programme for International Drug Monitoring (PIDM) member in 1998. The **Iran Food and Drug Administration (Iran FDA or IFDA)** under the Ministry of Health and Medical Education (MOHME) oversees PV through the **Iranian National Pharmacovigilance Center (PVC)** (established 1991, part of Iran FDA structure). The system focuses on spontaneous ADR reporting, signal detection, causality assessment, risk evaluation, alerts, recalls, and integration with public health programs (e.g., tuberculosis, antimicrobials). Reporting volumes are moderate (e.g., ~15 ADRs per 100,000 population in older data), with under-reporting (especially deaths) as a noted challenge, though structural conditions (policy, trained staff, budget) are relatively strong per WHO indicators.

No comprehensive standalone national **Good Pharmacovigilance Practices (GVP)** guide mirroring EU/ICH modules is prominently public in English or recent updates; operations follow WHO principles, national regulations, and regional influences (e.g., Arab GVP concepts). Key assessments (e.g., 2020–2022 studies) highlight a robust structural setup but gaps in public health program integration and full indicator assessment.

**Legal Framework and Governance**
- Regulated by Iran FDA laws/decrees and the PVC under MOHME.
- PVC (national center) collects ADRs, detects signals, assesses risks, issues alerts, and coordinates nationally (with regional centers in provinces/hospitals).
- Emphasis on post-marketing surveillance, rational use, and cross-sectoral cooperation.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/companies must monitor safety, collect/report ADRs (domestic/global), and comply with Iran FDA requirements.
- No strict mandatory local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is universally detailed in public sources (system relies more on national center coordination than stringent MAH-level obligations).
- No formal **PV System Master File (PSMF)** registration/location mandate.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (primary reporters), hospitals, patients, and MAHs report suspected ADRs (serious/unexpected prioritized), medication errors, or quality issues to PVC/Iran FDA (via forms, email, or channels).
- Timelines: Not rigidly codified with fixed calendar days in prominent public guidelines (follows WHO expectations); **prompt** reporting encouraged for serious/unexpected events to enable signal detection. Serious cases prioritized (regional practice often aligns with ICH-like 15 days for serious).

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions detailed publicly for all products.
- Safety updates may be required during renewals, variations, or on request (aligned with basic WHO/ICH-like formats).

**Risk Management Plans (RMP)**
- Not standard mandatory for all products. Risk assessment handled reactively through PVC surveillance, alerts, and regulatory decisions (e.g., for high-risk/biologics).

**Signal Management and Emerging Safety Issues**
- PVC conducts ongoing surveillance/signal detection (262 signals detected in 5-year periods in older data).
- MAHs monitor data and notify significant/emerging issues promptly (no fixed 5–45 day timelines publicly specified beyond general promptness).

**Clinical Trials-Related Safety Requirements**
Clinical trials require Iran FDA (Clinical Trials Center – CTC, established 2003) authorization, ethics committee review, and GCP adherence (aligned with WHO/ICH principles; CTC reviews protocols, post-marketing studies, and periodic safety updates).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting required (aligned with ICH E2A norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific in approvals).
- No dedicated national electronic system (e.g., no EudraVigilance); reports submitted directly to CTC/Iran FDA (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (ICH E2F or WHO formats), especially for ongoing/multi-country trials.
- Sponsor responsibility for monitoring, causality assessment, inspections/audits (multidisciplinary team possible), and communication to authorities/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Emphasis on spontaneous reporting from HCPs/hospitals, active PV in public health programs (e.g., vaccines, antimicrobials), quality surveillance, counterfeit detection, and training.
- Inspections/audits by Iran FDA possible; under-reporting persists (resource/awareness gaps), but improvements via guidelines and WHO support.

Iran's PV framework is WHO-aligned, centralized, and practical but relatively basic — no stringent MAH obligations like routine PSUR cycles, mandatory local QPPV/PSMF/RMP for all, or highly detailed timelines compared to ICH-harmonized systems (e.g., Turkey, Egypt). It prioritizes national center coordination and public health integration over complex industry requirements.

For precise, product- or trial-specific details (e.g., current ADR forms, exact timelines in Iran FDA guidelines, or clinical trial submissions), consult the **Iran Food and Drug Administration (Iran FDA)** directly via fda.gov.ir (or English portal sections; contact PVC or Clinical Trials Center), as requirements may evolve with updates or regional harmonization. Companies often align with WHO minimums for operations in Iran.

گروه ثبت و بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت
( ADR) Adverse Drug Reaction

1. معرفي گروه ثبت و  بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت :

گروه ثبت و بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت (ADR)، به عنوان تنها مرکز ملی در سطح کشور به جمع آوری، بررسی و ثبت گزارش های عوارض دارویی و اشتباهات داروپزشکی مشاهده شده توسط جامعه محترم پزشکی می پردازد. این مجموعه از سال 1377، تحت عنوان "مرکز ثبت و بررسی عوارض ناخواسته داروها" به عنوان عضو کامل سازمان جهانی بهداشت در برنامه بین المللی پایش فرآورده های دارویی پذیرفته شده است و از آن زمان تاکنون با سازمان مذکور و سایر کشورهای عضو به تبادل اطلاعات در زمینه عوارض دارویی و اشتباهات داروپزشکی می پردازد. هدف از بررسی عوارض دارویی و اشتباهات داروپزشکی دریافت شده، کاهش مرگ و میر ناشی از عوارض دارویی و اشتباهات داروپزشکی و پیشگیری از وقوع آنها می باشد. در بهمن ماه سال 1385، دستورالعمل ثبت عوارض و خطاهای دارویی از سوی معاونت محترم غذا و دارو با تائید وزیر محترم بهداشت، درمان وآموزش پزشکی به کلیه دانشگاههای علوم پزشکی و مراکز بهداشتی درمانی دولتی و خصوصی سراسر کشور ابلاغ گردید و کلیه مراکز ذیربط ملزم به گزارش عوارض و اشتباهات داروپزشکی مشاهده شده به این گروه گردیدند. هم چنین در سال 1384 بنابر رای کمیسیون قانونی ساخت و ورود داروها، شرکت های داروسازی موظف به ارسال گزارشهای مربوط به ایمنی فرآورده های خود به گروه ADR شده اند که این مطلب مجددا در ماده 10 دستورالعمل فوق الذکر مورد تاکید قرار گرفته است. در سال 1396، بدلیل اهمیت توجه به ایمنی مصرف سایر فرآورده های سلامت بغیر ازدارو و با هدف ارتقاء سیستم پایش تجویز و مصرف سایر فرآورده های سلامت در کنار فرآورده های دارویی، نام این مجموعه به "گروه ثبت و بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت" تغییر یافته است.

2. شرح وظایف گروه ثبت و  بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت

• نظارت و پایش امور مرتبط با ثبت، گزارش و بررسی عوارض ناخواسته دارو و فرآورده های سلامت
• ایجاد هماهنگی و نظارت بر سیستم به روز و یکپارچه فارماکوویژیلانس در کشور
• پیگیری امور مرتبط با ایمنی بیمار در زمینه ایمنی فرآورده های سلامت
• تهیه و تنظیم نامه های گزارش مربوط به عوارض جدی و مرگ و عوارض بیش از حد انتظار و غیرمعمول، اشکالات فیزیکوشیمیایی و نواقص مربوط به بسته بندی، بروشور و برچسب گذاری و ... به اداره کل دارو و مواد تحت کنترل، اداره کل امور فرآورده های طبیعی، سنتی و مکمل، اداره کل امور فرآورده های غذایی و آشامیدنی، اداره کل امور فرآورده های آرایشی و بهداشتی و اداره کل امور تجهیزات و ملزومات پزشکی
• پاسخ به نامه های ارسالی ازمعاونتهای غذاوداروی سراسر کشور و یا سایر ادارات، در خصوص بررسی عوارض ناخواسته فرآورده های سلامت
• تهیه و تنظیم اطلاعیه های گروه در رابطه با هشدارهای عوارض ناخواسته فرآورده های سلامت و ارسال فیدبک به گزارشگران
• شرکت در جلسات علمی- اجرایی سازمانی در حیطه امور مربوط به بررسی، ثبت و بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت و ایجاد ارتباطات درون بخشی و برون بخشی

3. پرسنل گروه ثبت و بررسی ایمنی و عوارض ناخواسته فرآورده های سلامت

رییس گروه : دکتر نغمه جاوید نیکوکارشناسان گروه : دکتر مرجان کریمی قوانلو، دکتر زهرا غزازانی، دکتر زهرا آزاد، دکتر یاسمن سادات میرفخرایی، خانم شیرین شکیبائیمسئول دفتر: خانم نیروانا بهجتشماره تماس: 66176934-61927144پست الكترونيك: iadrmc@fda.gov.ir

 

 

 

The pharmacovigilance (PV) system in **Iran** is functional and moderately mature, aligned with **WHO** minimum standards and contributing to VigiBase since Iran became a full WHO Programme for International Drug Monitoring (PIDM) member in 1998. The **Iran Food and Drug Administration (Iran FDA or IFDA)** under the Ministry of Health and Medical Education (MOHME) oversees PV through the **Iranian National Pharmacovigilance Center (PVC)** (established 1991, part of Iran FDA structure). The system focuses on spontaneous ADR reporting, signal detection, causality assessment, risk evaluation, alerts, recalls, and integration with public health programs (e.g., tuberculosis, antimicrobials). Reporting volumes are moderate (e.g., ~15 ADRs per 100,000 population in older data), with under-reporting (especially deaths) as a noted challenge, though structural conditions (policy, trained staff, budget) are relatively strong per WHO indicators.

No comprehensive standalone national **Good Pharmacovigilance Practices (GVP)** guide mirroring EU/ICH modules is prominently public in English or recent updates; operations follow WHO principles, national regulations, and regional influences (e.g., Arab GVP concepts). Key assessments (e.g., 2020–2022 studies) highlight a robust structural setup but gaps in public health program integration and full indicator assessment.

**Legal Framework and Governance**
- Regulated by Iran FDA laws/decrees and the PVC under MOHME.
- PVC (national center) collects ADRs, detects signals, assesses risks, issues alerts, and coordinates nationally (with regional centers in provinces/hospitals).
- Emphasis on post-marketing surveillance, rational use, and cross-sectoral cooperation.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/companies must monitor safety, collect/report ADRs (domestic/global), and comply with Iran FDA requirements.
- No strict mandatory local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is universally detailed in public sources (system relies more on national center coordination than stringent MAH-level obligations).
- No formal **PV System Master File (PSMF)** registration/location mandate.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- HCPs (primary reporters), hospitals, patients, and MAHs report suspected ADRs (serious/unexpected prioritized), medication errors, or quality issues to PVC/Iran FDA (via forms, email, or channels).
- Timelines: Not rigidly codified with fixed calendar days in prominent public guidelines (follows WHO expectations); **prompt** reporting encouraged for serious/unexpected events to enable signal detection. Serious cases prioritized (regional practice often aligns with ICH-like 15 days for serious).

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions detailed publicly for all products.
- Safety updates may be required during renewals, variations, or on request (aligned with basic WHO/ICH-like formats).

**Risk Management Plans (RMP)**
- Not standard mandatory for all products. Risk assessment handled reactively through PVC surveillance, alerts, and regulatory decisions (e.g., for high-risk/biologics).

**Signal Management and Emerging Safety Issues**
- PVC conducts ongoing surveillance/signal detection (262 signals detected in 5-year periods in older data).
- MAHs monitor data and notify significant/emerging issues promptly (no fixed 5–45 day timelines publicly specified beyond general promptness).

**Clinical Trials-Related Safety Requirements**
Clinical trials require Iran FDA (Clinical Trials Center – CTC, established 2003) authorization, ethics committee review, and GCP adherence (aligned with WHO/ICH principles; CTC reviews protocols, post-marketing studies, and periodic safety updates).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting required (aligned with ICH E2A norms; typically **7–15 days** for serious unexpected, faster for fatal/life-threatening; trial-specific in approvals).
- No dedicated national electronic system (e.g., no EudraVigilance); reports submitted directly to CTC/Iran FDA (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (ICH E2F or WHO formats), especially for ongoing/multi-country trials.
- Sponsor responsibility for monitoring, causality assessment, inspections/audits (multidisciplinary team possible), and communication to authorities/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Emphasis on spontaneous reporting from HCPs/hospitals, active PV in public health programs (e.g., vaccines, antimicrobials), quality surveillance, counterfeit detection, and training.
- Inspections/audits by Iran FDA possible; under-reporting persists (resource/awareness gaps), but improvements via guidelines and WHO support.

Iran's PV framework is WHO-aligned, centralized, and practical but relatively basic — no stringent MAH obligations like routine PSUR cycles, mandatory local QPPV/PSMF/RMP for all, or highly detailed timelines compared to ICH-harmonized systems (e.g., Turkey, Egypt). It prioritizes national center coordination and public health integration over complex industry requirements.

For precise, product- or trial-specific details (e.g., current ADR forms, exact timelines in Iran FDA guidelines, or clinical trial submissions), consult the **Iran Food and Drug Administration (Iran FDA)** directly via fda.gov.ir (or English portal sections; contact PVC or Clinical Trials Center), as requirements may evolve with updates or regional harmonization. Companies often align with WHO minimums for operations in Iran.