INOPP Forum
Pharmacovigilance Requirements in Papua New Guinea
Quote from VigiServe Admin on February 8, 2026, 8:15 AMIn Papua New Guinea (PNG), Pharmacovigilance is regulated by the National Department of Health (NDoH) through the Pharmaceutical Services Standards Branch (PSSB). The system is basic and developing, operating under the Medicines and Cosmetics Act 1999 with heavy reliance on WHO and the Pacific Islands regional network.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and require NDoH approval.
Framework: Aligned with ICH GCP and WHO standards.
Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in detailed national regulations, the 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 NDoH 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: There is no requirement for a local Qualified Person for Pharmacovigilance residing in PNG.
No PSMF Mandate: Not required.
Incident Reporting (ICSRs):
Enforcement: Voluntary/Spontaneous.
Timelines: "Prompt" reporting is expected for serious cases (generally interpreted as 15 days per Pacific regional norms).
Risk & Periodic Reporting:
PSURs: Not routinely mandatory; may be requested on an ad-hoc basis.
RMPs: Reactive; not a standard requirement.
Summary of Requirements
Component Requirement in Papua New Guinea Regulatory Authority NDoH (National Dept. of Health / PSSB) Regional Framework WHO / Pacific Islands Network Local QPPV / PSMF Not required Safety Reporting Spontaneous; "Prompt" reporting Clinical Reporting SUSARs (7/15 days - International practice) Regional Alignment WHO / Pacific
In Papua New Guinea (PNG), Pharmacovigilance is regulated by the National Department of Health (NDoH) through the Pharmaceutical Services Standards Branch (PSSB). The system is basic and developing, operating under the Medicines and Cosmetics Act 1999 with heavy reliance on WHO and the Pacific Islands regional network.
1. Clinical Safety (Clinical Trials)
Clinical trials are rare and require NDoH approval.
-
Framework: Aligned with ICH GCP and WHO standards.
-
Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in detailed national regulations, the 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 NDoH 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: There is no requirement for a local Qualified Person for Pharmacovigilance residing in PNG.
-
No PSMF Mandate: Not required.
-
-
Incident Reporting (ICSRs):
-
Enforcement: Voluntary/Spontaneous.
-
Timelines: "Prompt" reporting is expected for serious cases (generally interpreted as 15 days per Pacific regional norms).
-
-
Risk & Periodic Reporting:
-
PSURs: Not routinely mandatory; may be requested on an ad-hoc basis.
-
RMPs: Reactive; not a standard requirement.
-
Summary of Requirements
| Component | Requirement in Papua New Guinea |
| Regulatory Authority | NDoH (National Dept. of Health / PSSB) |
| Regional Framework | WHO / Pacific Islands Network |
| Local QPPV / PSMF | Not required |
| Safety Reporting | Spontaneous; "Prompt" reporting |
| Clinical Reporting | SUSARs (7/15 days - International practice) |
| Regional Alignment | WHO / Pacific |