Quote from VigiServe Admin on November 28, 2020, 9:38 AM

In Peru, Pharmacovigilance is a mature, ICH-aligned system enforced by the General Directorate of Medicines, Supplies and Drugs (DIGEMID) under the Ministry of Health. The framework is governed by Supreme Decree No. 016-2011-SA and strictly enforced technical directives (e.g., Directive No. 013-2019), making it one of the strongest in Latin America.

1. Clinical Safety (Clinical Trials)

Safety monitoring during clinical trials is aligned with ICH GCP and requires DIGEMID authorization.

• Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) in line 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 mandatory annually (ICH E2F format), particularly for ongoing trials.

• Oversight: Sponsors are responsible for causality assessment, maintaining insurance for trial-related injuries, and communicating with DIGEMID and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Post-approval obligations are rigorous, emphasizing local accountability and electronic reporting.

• Personnel: A Local Responsible Person for Pharmacovigilance (RLFV) is mandatory. This individual must be a qualified pharmacist or physician residing in Peru and registered with DIGEMID.

• Documentation: A Pharmacovigilance System Master File (PSMF) is required. It must be maintained locally and available for DIGEMID inspections, containing detailed content per Directive 013-2019.

• Incident Reporting (ICSRs):

  • Serious Cases: Report within 15 calendar days.

  • Non-Serious Cases: Report within 90 calendar days.

  • Submission: Electronic reporting via VigiFlow (E2B(R3) compatible) is mandatory.

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH E2C(R2) format. Typically required every 6 months for the first 2 years, then annually.

  • Risk Management Plans (RMPs): Required for new active substances, biologics, and high-risk products. Submissions must include a Peru-specific annex.

  • Surveillance: A mandatory post-marketing surveillance period (often 3–5 years) applies to new drugs.

Summary of Requirements

Component	Requirement in Peru
Regulatory Authority	DIGEMID (General Directorate of Medicines, Supplies and Drugs)
Local Personnel	Mandatory RLFV (Pharmacist/Physician)
PSMF	Required (Maintained locally)
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
ICSR Timelines	15 days (serious) / 90 days (non-serious)
RMPs	Mandatory (with Peru Annex)
System	VigiFlow (Mandatory)