INOPP Forum
Pharmacovigilance requirements in Argentina
Quote from VigiServe Admin on November 28, 2020, 10:10 AMIn Argentina, Pharmacovigilance is a mature, ICH-aligned system regulated by the National Administration of Drugs, Food and Medical Technology (ANMAT). The framework is defined by Disposición 5358/2012 (Good Pharmacovigilance Practices) and recent updates like Disposición 7516/2025 for clinical trials.
1. Clinical Safety (Clinical Trials)
Safety monitoring is rigorously enforced under Disposición 6677/2010 and the 2025 update aligning with ICH E6(R3).
Approvals: Trials require authorization from both ANMAT and an Ethics Committee.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) according to 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 mandatory, typically submitted annually in ICH E2F format.
Oversight: Sponsors bear full responsibility for causality assessment and communicating safety data to ANMAT and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are significant, requiring local presence and strict reporting adherence.
Personnel: A Local Responsible Person for Pharmacovigilance (RFV) is mandatory. This individual must be registered with ANMAT and is personally responsible for the system's compliance.
Documentation: While a formal Pharmacovigilance System Master File (PSMF) registration is not explicitly required, Marketing Authorization Holders (MAHs) must maintain detailed SOPs and system documentation available for ANMAT inspections.
Incident Reporting (ICSRs):
Serious/Unexpected Cases: Must be reported within 15 calendar days.
Non-Serious Cases: Reported within 90 calendar days or in periodic aggregates.
Scope: Foreign cases are generally included in periodic reports unless they impact the benefit-risk profile significantly.
Risk & Periodic Reporting:
PSURs/PBRERs: Submitted in ICH E2C(R2) format. Frequency is not fixed for all products but typically aligns with registration renewals, variations, or specific ANMAT requests.
Risk Management Plans (RMPs): Mandatory for new molecules, biologics, and high-risk products.
Summary of Requirements
Component Requirement in Argentina Regulatory Authority ANMAT (National Administration of Drugs, Food and Medical Technology) Local Responsible Person Mandatory (RFV - Responsable de Farmacovigilancia) PSMF Location Not mandatory to register, but system docs must be available locally. SUSAR Reporting 7 days (fatal/life-threatening) / 15 days (other serious). ICSR Timelines 15 days (serious) / 90 days (non-serious). RMPs Required for new/high-risk products and biologics.
In Argentina, Pharmacovigilance is a mature, ICH-aligned system regulated by the National Administration of Drugs, Food and Medical Technology (ANMAT). The framework is defined by Disposición 5358/2012 (Good Pharmacovigilance Practices) and recent updates like Disposición 7516/2025 for clinical trials.
1. Clinical Safety (Clinical Trials)
Safety monitoring is rigorously enforced under Disposición 6677/2010 and the 2025 update aligning with ICH E6(R3).
-
Approvals: Trials require authorization from both ANMAT and an Ethics Committee.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) according to 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 mandatory, typically submitted annually in ICH E2F format.
-
Oversight: Sponsors bear full responsibility for causality assessment and communicating safety data to ANMAT and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Post-approval obligations are significant, requiring local presence and strict reporting adherence.
-
Personnel: A Local Responsible Person for Pharmacovigilance (RFV) is mandatory. This individual must be registered with ANMAT and is personally responsible for the system's compliance.
-
Documentation: While a formal Pharmacovigilance System Master File (PSMF) registration is not explicitly required, Marketing Authorization Holders (MAHs) must maintain detailed SOPs and system documentation available for ANMAT inspections.
-
Incident Reporting (ICSRs):
-
Serious/Unexpected Cases: Must be reported within 15 calendar days.
-
Non-Serious Cases: Reported within 90 calendar days or in periodic aggregates.
-
Scope: Foreign cases are generally included in periodic reports unless they impact the benefit-risk profile significantly.
-
-
Risk & Periodic Reporting:
-
PSURs/PBRERs: Submitted in ICH E2C(R2) format. Frequency is not fixed for all products but typically aligns with registration renewals, variations, or specific ANMAT requests.
-
Risk Management Plans (RMPs): Mandatory for new molecules, biologics, and high-risk products.
-
Summary of Requirements
| Component | Requirement in Argentina |
| Regulatory Authority | ANMAT (National Administration of Drugs, Food and Medical Technology) |
| Local Responsible Person | Mandatory (RFV - Responsable de Farmacovigilancia) |
| PSMF Location | Not mandatory to register, but system docs must be available locally. |
| SUSAR Reporting | 7 days (fatal/life-threatening) / 15 days (other serious). |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious). |
| RMPs | Required for new/high-risk products and biologics. |