Quote from VigiServe Admin on November 29, 2020, 5:42 AM

Pharmacovigilance Requirements in Russia

The pharmacovigilance (PV) system in **Russia** is robust, centralized, and aligned with **Eurasian Economic Union (EAEU)** Good Pharmacovigilance Practices (GVP) guidelines (Decision No. 87 of 2016, as amended) and **WHO** standards. Russia is a full WHO PIDM member and contributes to VigiBase. The **Federal Service for Surveillance in Healthcare (Roszdravnadzor)**, under the Ministry of Health, is the primary authority, overseeing ADR/AEFI collection, signal detection, causality assessment, risk evaluation, inspections, alerts, recalls, and safety communications. The system emphasizes post-marketing surveillance, mandatory electronic reporting, and harmonization with EAEU rules (binding for member states, including Russia).

**Legal Framework and Governance**
- Key regulations:
- **Order No. 1071n** (2016): Establishes PV rules and national system structure.
- **Order No. 200n** (2019): Detailed ADR reporting and risk management requirements.
- EAEU GVP (Decision No. 87/2016, amended) applies directly.
- Roszdravnadzor coordinates nationally, with regional offices and electronic platforms for submissions (E2B(R3) compatible).

**Organization and Personnel**
- Marketing Authorization Holders (MAHs) must establish and maintain a compliant PV system.
- Appoint a **Responsible Person for Pharmacovigilance (RPPV / local QPPV)**: Mandatory; must be a qualified professional (pharmacist or physician) residing in Russia (or EAEU), serving as the primary Roszdravnadzor contact.
- **Pharmacovigilance System Master File (PSMF)**: Required (per EAEU GVP); describes the PV system, must be maintained/updated and available for inspections (no mandatory registration/location, but accessibility enforced).

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- MAHs must collect/report all suspected ADRs (serious/non-serious), medication errors, lack of efficacy, and quality defects electronically to Roszdravnadzor.
- **Timelines** (aligned with EAEU/ICH):
- **Serious ICSRs** (domestic/unexpected): Expedited within **15 calendar days** of receipt/awareness.
- **Non-serious ICSRs**: Within **90 calendar days** or periodic aggregates.
- Foreign serious ICSRs: **15 calendar days** if relevant to benefit-risk.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- MAHs submit PSURs/PBRERs (ICH E2C(R2) format) to Roszdravnadzor.
- Frequency: Typically every **6 months** initially (first 2 years post-authorization), then **annually** or as specified (harmonized with EAEU; submission within **90 calendar days** of data lock point for longer intervals).

**Risk Management Plans (RMP)**
- Required for new active substances, biologics, high-risk products, or specific concerns (per EAEU GVP Module V).
- Submit RMP with pharmacovigilance plan and risk minimization measures; updates for new risks or significant changes (national annex if EU/global RMP exists).

**Signal Management and Emerging Safety Issues**
- MAHs continuously monitor global/local data; notify Roszdravnadzor of validated signals or emerging concerns promptly.
- Roszdravnadzor leads national signal detection (using WHO tools like VigiLyze).

**Clinical Trials-Related Safety Requirements**
Clinical trials require Roszdravnadzor authorization (via Clinical Trial Application; aligned with ICH GCP and EAEU principles).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting (aligned with ICH E2A/EAEU norms):
- Fatal/life-threatening SUSARs: **7 calendar days**.
- Other serious unexpected SUSARs: **15 calendar days**.
- No dedicated national EudraVigilance equivalent; reports submitted directly to Roszdravnadzor (electronic/forms).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates required (ICH E2F or WHO 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 scheme.
- Emphasis on biologics, vaccines, and public health programs (active PV in priority areas).
- Risk-based GVP inspections by Roszdravnadzor (enhanced post-2025 updates).
- Reporting volumes moderate; improvements via training and EAEU harmonization.

Russia's PV framework is **EAEU-harmonized** and robust (mandatory local RPPV/PSMF/RMP, 15/90-day ICSR timelines, routine PSUR/RMP, expedited SUSAR/DSUR), one of the strongest in the CIS region. It balances regional obligations with national enforcement.

For precise, product- or trial-specific details (e.g., latest forms, exact timelines in 2025–2026 orders, or clinical trial submissions), consult **Roszdravnadzor** directly via roszdravnadzor.gov.ru (English section available) or the Ministry of Health, as requirements evolve with EAEU updates. Companies often appoint a local RPPV and align with EAEU GVP for compliance.