Quote from VigiServe Admin on November 28, 2020, 9:47 AM

Pharmacovigilance requirements in Cuba

The pharmacovigilance (PV) system in **Cuba** is well-established, centralized, and aligned with **WHO** standards, with Cuba being one of the first Caribbean nations to join the WHO Programme for International Drug Monitoring (PIDM) in 1994. It ranks among the top global contributors to VigiBase in reporting rates per million inhabitants. The system emphasizes integrated surveillance within the public health framework, strong spontaneous reporting, and pharmacoepidemiology.

**Legal Framework and Governance**
- Primary authority: **Center for State Control of Medicines, Equipment and Medical Devices (CECMED – Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos)** under the Ministry of Public Health (MINSAP). CECMED regulates medicines, biologics, vaccines, and medical devices, including PV activities.
- Key oversight: **National Pharmacovigilance Coordinating Unit (UCNFv – Unidad Coordinadora Nacional de Farmacovigilancia)** within the Department of Pharmacoepidemiology (often linked to CECMED/MINSAP structures).
- PV is governed by public health laws (e.g., Law of Public Health 1988) and CECMED regulations (e.g., various resolutions on registration, vigilance, and post-marketing requirements; no single comprehensive GVP guide is prominently public, but operations follow WHO/PAHO principles and regional harmonization efforts).
- Reporting uses the national electronic database **FarmaVigiC**, which feeds into VigiBase via Uppsala Monitoring Centre (UMC). Signals are detected nationally and shared quarterly with WHO.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/manufacturers/importers (often state entities or international partners) must monitor product safety post-marketing and report to UCNFv/CECMED.
- No strict mandatory requirement for a local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is detailed in public sources (system relies more on national coordination than stringent MAH-level obligations).
- No formal **PV System Master File (PSMF)** registration or location mandate.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- Healthcare professionals (HCPs), institutions, and MAHs report suspected adverse drug reactions (ADRs), medication errors, or quality issues to UCNFv/CECMED (via forms, electronic systems, or institutional networks).
- Timelines: Not rigidly codified with fixed calendar days in publicly detailed national regulations (e.g., no universal 15/90-day rule like in many Latin American peers). Serious/unexpected events are expected to be reported **promptly/immediately** (aligned with WHO expectations and regional Latin American practices, where serious ADRs often fall within 7–15 days).
- Reports are analyzed for signals; high reporting rates reflect strong integration into the public health system.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- No routine mandatory periodic submissions (e.g., 6-monthly/annual) are explicitly detailed publicly for all products.
- Safety updates may be required during registration renewals, variations, or on request by CECMED, often aligned with basic WHO/PAHO formats.

**Risk Management Plans (RMP)**
- Not a standard mandatory requirement for all products. Risk assessment and minimization occur reactively through national surveillance, signal detection, and CECMED decisions (e.g., for high-priority biologics/vaccines).

**Signal Management and Emerging Safety Issues**
- UCNFv/CECMED conducts ongoing surveillance and signal detection (using FarmaVigiC and WHO tools).
- MAHs monitor data and notify significant/emerging issues promptly (no fixed timelines like 5–45 days publicly specified beyond general promptness).

**Clinical Trials-Related Safety Requirements**
Clinical trials require CECMED authorization (via specific regulations, e.g., Regulation 27/00 for phases I/II; broader guidelines for GCP and oversight). Cuba has extensive experience in trials (e.g., for innovative biologics/vaccines like those developed during COVID-19).
- Sponsors monitor safety and report serious adverse events/SAEs to CECMED.
- **Suspected Unexpected Serious Adverse Reactions (SUSARs)**: Expedited reporting required (aligned with international/ICH E2A norms; typically 7–15 days for serious unexpected, faster for fatal/life-threatening, though exact days are trial-specific or per CECMED approval).
- No dedicated national electronic system like EudraVigilance; reports submitted directly to CECMED (forms/email/institutional channels).
- Periodic reporting: **Development Safety Update Reports (DSURs)** or annual safety/progress reports may be required/requested (following ICH E2F or WHO formats), especially for ongoing or multi-phase trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to CECMED/ethics committees (integrated with national health system).

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Strong emphasis on active PV in public health programs (e.g., vaccines, antiretrovirals, innovative Cuban biologics), counterfeit detection, and pharmacoepidemiology.
- Inspections/audits by CECMED possible; high ADR reporting due to system integration and awareness, with ongoing WHO/PAHO support for harmonization.

Cuba's PV framework is functional, centralized, and effective within its public-health-oriented model — high reporting performance but less prescriptive on MAH-specific obligations (no routine PSUR cycles, no strict local QPPV/PSMF mandates) compared to more ICH-harmonized Latin American systems (e.g., Colombia, Brazil). It prioritizes national coordination and global contribution over detailed industry bureaucracy.

For precise, product- or trial-specific requirements (e.g., current reporting forms, timelines in specific CECMED resolutions, or clinical trial guidelines), consult **CECMED** directly via cecmed.cu (Reglamentación section for approved dispositions/resolutions, or contact channels), as details may evolve through updates (e.g., 2024–2025 resolutions on related topics like stability or quality). Companies operating in Cuba often align with WHO standards and CECMED directives for compliance.