INOPP Forum
Pharmacovigilance requirements in Mexico
Quote from VigiServe Admin on November 28, 2020, 9:44 AMIn Mexico, Pharmacovigilance is enforced by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) via the National Pharmacovigilance Center (CNFV). The system is mature and highly regulated under Official Mexican Standard NOM-220-SSA1-2016, aligning closely with ICH standards.
1. Clinical Safety (Clinical Trials)
Clinical trials require COFEPRIS approval and strict adherence to ICH GCP.
Expedited Reporting (SUSARs): 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 mandatory annually (ICH E2F format).
Oversight: Sponsors manage causality assessment and communication with COFEPRIS and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Mexico places significant obligations on Marketing Authorization Holders (MAHs), including mandatory local personnel and specific surveillance periods for new drugs.
Personnel: A Local Responsible Person (RLFV - Responsable Local de Farmacovigilancia) is mandatory. This individual must be a qualified pharmacist or physician, resident in Mexico, and registered with COFEPRIS.
Documentation: A Pharmacovigilance System Master File (PSMF) is required. It must be maintained locally and available for inspection (per NOM-220).
Incident Reporting (ICSRs):
Serious Cases: Report within 15 calendar days.
Non-Serious Cases: Report within 90 calendar days.
Platform: Electronic reporting via VigiFlow (MedDRA/WHODrug coding required).
Risk & Periodic Reporting:
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years) then annually.
Risk Management Plans (RMPs): Mandatory for new molecules, biologics, and high-risk products.
Surveillance: A mandatory post-marketing surveillance period (often 3–5 years) applies to new drugs.
Summary of Requirements
Component Requirement in Mexico Regulatory Authority COFEPRIS (CNFV) Local Responsible Person Mandatory (RLFV - Resident) PSMF Required (Maintained locally) SUSAR Reporting 7 days (fatal) / 15 days (other serious) ICSR Timelines 15 days (serious) / 90 days (non-serious) RMPs & PSURs Mandatory
In Mexico, Pharmacovigilance is enforced by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) via the National Pharmacovigilance Center (CNFV). The system is mature and highly regulated under Official Mexican Standard NOM-220-SSA1-2016, aligning closely with ICH standards.
1. Clinical Safety (Clinical Trials)
Clinical trials require COFEPRIS approval and strict adherence to ICH GCP.
-
Expedited Reporting (SUSARs): 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 mandatory annually (ICH E2F format).
-
Oversight: Sponsors manage causality assessment and communication with COFEPRIS and Ethics Committees.
2. Post-Marketing Pharmacovigilance
Mexico places significant obligations on Marketing Authorization Holders (MAHs), including mandatory local personnel and specific surveillance periods for new drugs.
-
Personnel: A Local Responsible Person (RLFV - Responsable Local de Farmacovigilancia) is mandatory. This individual must be a qualified pharmacist or physician, resident in Mexico, and registered with COFEPRIS.
-
Documentation: A Pharmacovigilance System Master File (PSMF) is required. It must be maintained locally and available for inspection (per NOM-220).
-
Incident Reporting (ICSRs):
-
Serious Cases: Report within 15 calendar days.
-
Non-Serious Cases: Report within 90 calendar days.
-
Platform: Electronic reporting via VigiFlow (MedDRA/WHODrug coding required).
-
-
Risk & Periodic Reporting:
-
PSURs: Submitted in ICH E2C(R2) format. Typically every 6 months (first 2 years) then annually.
-
Risk Management Plans (RMPs): Mandatory for new molecules, biologics, and high-risk products.
-
Surveillance: A mandatory post-marketing surveillance period (often 3–5 years) applies to new drugs.
-
Summary of Requirements
| Component | Requirement in Mexico |
| Regulatory Authority | COFEPRIS (CNFV) |
| Local Responsible Person | Mandatory (RLFV - Resident) |
| PSMF | Required (Maintained locally) |
| SUSAR Reporting | 7 days (fatal) / 15 days (other serious) |
| ICSR Timelines | 15 days (serious) / 90 days (non-serious) |
| RMPs & PSURs | Mandatory |
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