INOPP Forum
Pharmacovigilance Requirements in El Salvador
Quote from VigiServe Admin on February 8, 2026, 11:05 AMIn El Salvador, Pharmacovigilance is regulated by the Dirección Nacional de Medicamentos (DNM) under the Ministry of Health (MINSA). The system is moderately developed and harmonized with Central American technical regulations, emphasizing local responsibility.
1. Clinical Safety (Clinical Trials)
Clinical trials require DNM approval and adherence to ICH GCP standards.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) consistent with ICH E2A:
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.
Submission: Reports are submitted via DNM channels (electronic or forms).
2. Post-Marketing Pharmacovigilance
Post-approval obligations emphasize local accountability and risk management for high-risk products.
Personnel: A Local Responsible Person for Pharmacovigilance (RLFV) is mandatory. This individual must be a qualified professional (pharmacist or physician) residing in El Salvador and registered with the DNM.
Documentation: While a formal PSMF is not explicitly mandatory in public sources, documented PV procedures (SOPs) are required for inspections.
Incident Reporting (ICSRs):
Serious Cases: Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Risk & Periodic Reporting:
PSURs: Frequency is not rigidly standardized; typically submitted upon request, during renewals, or for safety concerns.
RMPs: Mandatory for new products, biologics, vaccines, and high-risk medicines.
Summary of Requirements
Component Requirement in El Salvador Regulatory Authority DNM (Dirección Nacional de Medicamentos) Regional Framework Central American Harmonization Local Personnel Mandatory RLFV (Pharmacist/Physician) PSMF Not explicitly mandatory (Docs required) Serious ICSR Timeline 15 Days Clinical Reporting SUSARs (7/15 days) RMPs Mandatory (High Risk/New)
In El Salvador, Pharmacovigilance is regulated by the Dirección Nacional de Medicamentos (DNM) under the Ministry of Health (MINSA). The system is moderately developed and harmonized with Central American technical regulations, emphasizing local responsibility.
1. Clinical Safety (Clinical Trials)
Clinical trials require DNM approval and adherence to ICH GCP standards.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) consistent with ICH E2A:
-
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.
-
Submission: Reports are submitted via DNM channels (electronic or forms).
2. Post-Marketing Pharmacovigilance
Post-approval obligations emphasize local accountability and risk management for high-risk products.
-
Personnel: A Local Responsible Person for Pharmacovigilance (RLFV) is mandatory. This individual must be a qualified professional (pharmacist or physician) residing in El Salvador and registered with the DNM.
-
Documentation: While a formal PSMF is not explicitly mandatory in public sources, documented PV procedures (SOPs) are required for inspections.
-
Incident Reporting (ICSRs):
-
Serious Cases: Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
-
Risk & Periodic Reporting:
-
PSURs: Frequency is not rigidly standardized; typically submitted upon request, during renewals, or for safety concerns.
-
RMPs: Mandatory for new products, biologics, vaccines, and high-risk medicines.
-
Summary of Requirements
| Component | Requirement in El Salvador |
| Regulatory Authority | DNM (Dirección Nacional de Medicamentos) |
| Regional Framework | Central American Harmonization |
| Local Personnel | Mandatory RLFV (Pharmacist/Physician) |
| PSMF | Not explicitly mandatory (Docs required) |
| Serious ICSR Timeline | 15 Days |
| Clinical Reporting | SUSARs (7/15 days) |
| RMPs | Mandatory (High Risk/New) |