Quote from VigiServe Admin on February 6, 2026, 1:18 PM

In Panama, Pharmacovigilance is regulated by the Ministry of Health (MINSA) through the National Directorate of Pharmacy and Drugs (DNFD). The framework was significantly strengthened by the Manual de Buenas Prácticas de Farmacovigilancia (BPFV) 2023 (effective 2024) and Law 419/2024, aligning it with ICH standards and regional Central American norms.

1. Clinical Safety (Clinical Trials)

Clinical trials must be approved by the DNFD and adhere to ICH GCP principles.

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

• Oversight: Sponsors are responsible for monitoring safety, causality assessment, and communicating with the DNFD and Ethics Committees.

2. Post-Marketing Pharmacovigilance

Recent updates have introduced stricter obligations for Marketing Authorization Holders (MAHs), including mandatory personnel and standardized reporting.

• Personnel: A Local Responsible Person (Responsable de Farmacovigilancia) is mandatory. This individual must be a qualified professional (Pharmacist or Physician) registered with the DNFD to serve as the primary liaison.

• Documentation: While a formal PSMF registration is not explicitly detailed, MAHs must document their PV procedures and make them available for inspection.

• Incident Reporting (ICSRs):

  • Serious (Unexpected/Severe): Report within 15 calendar days.

  • Non-Serious: Report within 90 calendar days.

  • Foreign Cases: Serious unexpected cases relevant to benefit-risk reported within 15 days.

  • System: Transitioned to WHODrug Global and MedDRA coding in 2024.

• Risk & Periodic Reporting:

  • PSURs: Submitted in ICH E2C(R2)-like format. Timelines are typically linked to registration renewals or specific requests.

  • Risk Management Plans (RMPs): Mandatory for new molecules, biologics, and high-risk products (EU or global RMPs accepted with a national annex).

Summary of Requirements

Component	Requirement in Panama
Regulatory Authority	MINSA / DNFD (National Directorate of Pharmacy and Drugs)
Local Responsible Person	Mandatory (Pharmacist/Physician)
PSMF	Procedures must be documented for inspection.
SUSAR Reporting	7 days (fatal) / 15 days (other serious)
ICSR Timelines	15 days (serious) / 90 days (non-serious)
RMPs & PSURs	Required for high-risk/new products; PSURs on request/renewal.