INOPP Forum
Pharmacovigilance requirements in Honduras
Quote from VigiServe Admin on February 8, 2026, 4:41 AMIn Honduras, Pharmacovigilance is regulated by the Agencia de Regulación Sanitaria (ARSA) under the Ministry of Health. The system operates as a basic-to-moderate framework, aligning with WHO standards and Central American harmonization efforts.
1. Clinical Safety (Clinical Trials)
Clinical trials require ARSA authorization and adherence to ICH GCP principles.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) consistent with ICH E2A standards:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually or periodically (ICH E2F format).
Oversight: Sponsors are responsible for causality assessment, insurance coverage, and communication with ARSA and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are evolving, focusing on local accountability and regional alignment.
Personnel: A Local Responsible Person for Pharmacovigilance (RLFV) is mandatory. This individual must be a qualified professional (pharmacist or physician) residing in Honduras and registered with ARSA.
Documentation: While a formal Pharmacovigilance System Master File (PSMF) is not explicitly mandatory in public guidelines, companies are expected to document PV procedures and make them available for inspection.
Incident Reporting (ICSRs):
Serious Cases: Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Submission: Reporting is conducted via ARSA channels, including VigiFlow, email, or standard forms.
Risk & Periodic Reporting:
PSURs: Submitted in an ICH E2C(R2)-like format. Frequency is typically determined during registration renewal or upon request.
Risk Management Plans (RMPs): Required for new products, biologics, vaccines, and high-risk medicines. Submissions often include a Honduras-specific annex.
Summary of Requirements
Component Requirement in Honduras Regulatory Authority ARSA (Agencia de Regulación Sanitaria) Local Personnel Mandatory RLFV (Pharmacist/Physician) PSMF Not explicitly mandatory (Procedures must be documented) SUSAR Reporting 7 days (fatal) / 15 days (other serious) ICSR Timelines 15 days (serious) / 90 days (non-serious) RMPs Mandatory (High Risk/New Products) System VigiFlow / ARSA Forms
In Honduras, Pharmacovigilance is regulated by the Agencia de Regulación Sanitaria (ARSA) under the Ministry of Health. The system operates as a basic-to-moderate framework, aligning with WHO standards and Central American harmonization efforts.
1. Clinical Safety (Clinical Trials)
Clinical trials require ARSA authorization and adherence to ICH GCP principles.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) consistent with ICH E2A standards:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) are required annually or periodically (ICH E2F format).
-
Oversight: Sponsors are responsible for causality assessment, insurance coverage, and communication with ARSA and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are evolving, focusing on local accountability and regional alignment.
-
Personnel: A Local Responsible Person for Pharmacovigilance (RLFV) is mandatory. This individual must be a qualified professional (pharmacist or physician) residing in Honduras and registered with ARSA.
-
Documentation: While a formal Pharmacovigilance System Master File (PSMF) is not explicitly mandatory in public guidelines, companies are expected to document PV procedures and make them available for inspection.
-
Incident Reporting (ICSRs):
-
Serious Cases: Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
Submission: Reporting is conducted via ARSA channels, including VigiFlow, email, or standard forms.
-
-
Risk & Periodic Reporting:
-
PSURs: Submitted in an ICH E2C(R2)-like format. Frequency is typically determined during registration renewal or upon request.
-
Risk Management Plans (RMPs): Required for new products, biologics, vaccines, and high-risk medicines. Submissions often include a Honduras-specific annex.
-
Summary of Requirements
| Component | Requirement in Honduras |
| Regulatory Authority | ARSA (Agencia de Regulación Sanitaria) |
| Local Personnel | Mandatory RLFV (Pharmacist/Physician) |
| PSMF | Not explicitly mandatory (Procedures must be documented) |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious) |
| RMPs | Mandatory (High Risk/New Products) |
| System | VigiFlow / ARSA Forms |