Quote from VigiServe Admin on November 28, 2020, 10:04 AM

Pharmacovigilance requirements in Costa Rica

The pharmacovigilance (PV) system in **Costa Rica** is established and aligned with international standards (e.g., WHO principles and regional Latin American/PAHO harmonization efforts), though less prescriptive than full ICH-aligned systems in larger markets. Costa Rica is a full member of the WHO Programme for International Drug Monitoring (PIDM), contributing to VigiBase. The system emphasizes post-marketing surveillance, spontaneous ADR reporting, and regulatory oversight, with a focus on patient safety in a public-health-oriented context.

**Legal Framework and Governance**
- Primary authority: **Ministerio de Salud** (Ministry of Health), through the **Dirección de Regulación de Productos de Interés Sanitario (DRPIS)** or equivalent unit (formerly linked to registration processes). The **Sistema Nacional de Farmacovigilancia** coordinates activities.
- Key regulations:
- **Decreto Ejecutivo Nº 35244-S** (2009) – Establishes the National Pharmacovigilance System and obligations.
- **Reglamento de Buenas Prácticas de Farmacovigilancia** (related to good PV practices for human medicines).
- Additional circulars and updates (e.g., CIRCULAR MS-DRPIS-1888-2025 on management of suspected adverse reactions/RAM and AEFI notifications).
- The Ministry oversees ADR collection, signal detection, risk evaluation, alerts, and coordination with public institutions like the **Caja Costarricense de Seguro Social (CCSS)** for health program integration.

**Organization and Personnel**
- Marketing Authorization Holders (MAHs)/titulares de registro or local representatives must monitor product safety and report to the Ministry/DRPIS.
- No strict mandatory local **Qualified Person for Pharmacovigilance (QPPV)** or resident PV contact is universally required in public guidelines (though local representation is often needed for registration/compliance).
- No formal **PV System Master File (PSMF)** registration or location mandate is detailed publicly.

**Individual Case Safety Reports (ICSRs) – Post-Marketing**
- Suspected adverse reactions (ADRs/RAM), including serious/unexpected, medication errors, or quality issues, reported by HCPs, patients, or MAHs to the Ministry (via forms or channels).
- Timelines (per regulatory summaries and obligations):
- **Serious adverse events** (local/domestic): Within **24 hours** (or expedited as per sources).
- **Non-serious events**: Within **10 working days** or periodic aggregates.
- Reports feed into national analysis and VigiBase; emphasis on prompt serious reporting.

**Periodic Benefit-Risk Evaluation Reports (PBRER/PSUR)**
- Required in some cases (e.g., for certain products per regional harmonization).
- No routine mandatory frequency (e.g., no standard 6-monthly/annual cycle) detailed publicly for all; submissions occur during renewals, variations, or on request (aligned with basic WHO/PAHO formats).

**Risk Management Plans (RMP)**
- Not standard mandatory for all products. Risk management handled reactively through national surveillance and Ministry decisions (e.g., for biologics or high-risk items under special acquisition rules).

**Signal Management and Emerging Safety Issues**
- Ministry conducts ongoing surveillance and signal detection.
- 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 Ministry of Health approval (via CONIS – Consejo Nacional de Investigación en Salud or equivalent ethics/regulatory review under Law 9234 on biomedical research, 2014).
- Sponsors monitor safety and report serious adverse events/SAEs.
- **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 timelines are trial-specific or per approval rather than rigidly codified nationally).
- No dedicated national electronic system (e.g., no EudraVigilance/CTIS); reports submitted directly to the Ministry (forms/email).
- Periodic safety reporting: **Development Safety Update Reports (DSURs)** or annual updates may be required/requested (following ICH E2F or WHO formats), especially for ongoing trials.
- Sponsor responsibility for monitoring, causality assessment, and communication to authorities/ethics committees.

**Additional Monitoring / Other Aspects**
- No black triangle/additional monitoring scheme.
- Focus on spontaneous reporting from HCPs/institutions, quality surveillance (e.g., for biologics under CCSS procurement rules), counterfeit detection, and public health programs.
- Inspections/audits possible; reporting volumes moderate, with ongoing improvements via guidelines and awareness.

Costa Rica's PV framework is functional and WHO-aligned but relatively basic — no stringent MAH obligations like routine PSUR cycles, mandatory local QPPV/PSMF/RMP for all, or highly detailed timelines compared to more advanced Latin American systems (e.g., Colombia, Brazil). It prioritizes national coordination and spontaneous reporting over complex industry requirements.

For precise, product- or trial-specific details (e.g., current forms, exact timelines in Decreto 35244-S or 2025 circulars, or clinical trial submissions under Law 9234), consult the **Ministerio de Salud** directly via ministeriodesalud.go.cr (Farmacovigilancia section, biblioteca de archivos, or DRPIS contacts), as requirements may evolve with updates (e.g., 2025 communications). Companies often align with WHO minimums or reference regional PAHO standards for operations in Costa Rica.