Quote from VigiServe Admin on February 8, 2026, 11:09 AM

In Timor-Leste, the pharmacovigilance system is emerging and currently relies on the 2025 Pharmacovigilance Manual and WHO South-East Asia (SEARO) support. The National Directorate for Pharmacy and Medicines (NDPM) is the coordinating authority.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare and require NDPM authorization.

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). Practice aligns with international (ICH E2A) standards:

  • Fatal or Life-Threatening: Within 7 calendar days.

  • Other Serious Unexpected: Within 15 calendar days.

• Submission: Reports go directly to the NDPM via email or forms.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files.

• Personnel & Infrastructure:

  • No Local QPPV: Not required.

  • No PSMF Mandate: Not required.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous.

  • Timelines: "Prompt" reporting is expected for serious cases (generally interpreted as 15 days).

• Risk & Periodic Reporting:

  • PSURs/RMPs: Not routinely mandatory; handled reactively.

Summary of Requirements

Component	Requirement in Timor-Leste
Regulatory Authority	NDPM (Nat. Directorate for Pharmacy)
Framework	2025 Manual / WHO / SEARO
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting
Clinical Reporting	SUSARs (7/15 days - International practice)
Submission Language	English / Portuguese