Quote from VigiServe Admin on November 28, 2020, 10:09 AM

In Venezuela, Pharmacovigilance is coordinated by the National Institute of Hygiene "Rafael Rangel" (INHRR) under the Ministry of Popular Power for Health (MPPS). The system is functional but faces significant enforcement challenges due to economic and institutional constraints, relying heavily on voluntary reporting and WHO/PAHO guidelines.

1. Clinical Safety (Clinical Trials)

Clinical trials require INHRR/MPPS approval and adherence to international/PAHO norms.

• Expedited Reporting (SUSARs): Sponsors generally follow ICH E2A standards in practice:

  • Fatal or Life-Threatening: Within 7 days.

  • Other Serious Unexpected: Within 15 days.

• Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates may be requested (ICH E2F format).

• Submission: Direct to INHRR/MPPS via forms or email; no national electronic portal exists.

2. Post-Marketing Pharmacovigilance

Post-approval obligations for Marketing Authorization Holders (MAHs) are minimal and lack strict enforcement.

• Personnel & Infrastructure:

  • Local QPPV: Not required (no enforced registration).

  • PSMF: Not required.

• Incident Reporting (ICSRs):

  • Reporting is largely voluntary and spontaneous, primarily from the public sector.

  • Timelines: Not rigidly enforced. "Prompt" reporting is expected for serious events (regional practice aligns with 15 days).

• Risk & Periodic Reporting:

  • PSURs/PBRERs: Not routinely required. May be requested during registration renewal.

  • Risk Management Plans (RMPs): Not required as a standard.

Summary of Requirements

Component	Requirement in Venezuela
Regulatory Authority	INHRR (National Institute of Hygiene)
Local QPPV	Not required
PSMF	Not required
SUSAR Reporting	7–15 days (Best practice)
ICSR Timelines	"Prompt" (No fixed enforcement)
RMPs & PSURs	On request only

 

Reporting via

Post:

CENTRO DE FARMACOVIGILANCIA

Facultad de Farmacia,

Universidad Central de Venezuela

​

Tel: (0212) 6052698

Fax: (0212) 6052707

E-Mail: cefarvi@ucv.ve