Quote from VigiServe Admin on December 12, 2020, 1:01 PM

ONLINE ADVERSE EVENT REPORTING

In Bolivia, Pharmacovigilance is regulated by the Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED), a decentralized entity under the Ministry of Health. The system aligns with WHO minimum standards, prioritizing spontaneous reporting and active surveillance for specific diseases like Chagas and Tuberculosis.

1. Clinical Safety (Clinical Trials)

Safety monitoring requires AGEMED authorization and strict adherence to GCP.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While timelines are not rigidly codified in national law, they generally follow international norms:

  • Fatal or Life-Threatening: Typically within 7 days.

  • Other Serious Unexpected: Typically within 15 days.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual safety updates (ICH E2F format) are required, particularly for ongoing trials.

• Submission Method: Reports are submitted directly to AGEMED via email or physical forms; there is no dedicated electronic portal.

• Oversight: Sponsors are responsible for causality assessment and communication with AGEMED and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Post-approval surveillance relies on hospital-based committees and spontaneous reporting rather than complex industry mandates.

• Governance: The Centro Nacional de Farmacovigilancia is integrated within AGEMED. Hospital Pharmacovigilance Committees play a key role in active monitoring and causality analysis.

• Personnel & Infrastructure:

  • No Local QPPV: There is no strict public requirement for a local Qualified Person for Pharmacovigilance.

  • No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or locate a Pharmacovigilance System Master File in Bolivia.

• Incident Reporting (ICSRs):

  • MAHs and healthcare professionals report suspected adverse events using Formulario 020.

  • Timelines: Not rigidly fixed, but "prompt" reporting is required for serious or unexpected events (generally interpreted as 15 days).

• Periodic & Risk Reporting:

  • Informes Periódicos de Seguridad (IPS): Periodic safety reports are required per Resolución Ministerial N° 1110 (referenced in Circular 37-2025). Frequency is typically periodic or upon request.

  • Risk Management Plans (RMPs): Not a standard mandatory requirement for all products; risk assessment is largely reactive.

Summary of Requirements

Component	Requirement in Bolivia
Regulatory Authority	AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud)
Key Regulation	Ley del Medicamento (No. 1737); RM N° 1110 (IPS)
Local QPPV / PSMF	Not required
Safety Reporting	Formulario 020; "Prompt" reporting
Clinical Reporting	SUSARs (Expedited); DSURs (Annual)
Periodic Reports	IPS (Informes Periódicos de Seguridad)