INOPP Forum
Pharmacovigilance requirements in Laos
Quote from VigiServe Admin on February 8, 2026, 2:01 AMIn Laos, Pharmacovigilance is regulated by the Food and Drug Department (FDD) under the Ministry of Health. The system is basic and functional, operating under WHO minimum standards and ASEAN regional guidelines without a standalone national GVP law.
1. Clinical Safety (Clinical Trials)
Clinical trials require FDD authorization and adherence to international norms.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in rigid national statutes, the expectation aligns with ICH E2A and ASEAN standards:
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Periodic Reporting: Development Safety Update Reports (DSURs) or annual safety updates are typically required (ICH E2F format).
Submission: Reports are submitted directly to the FDD via email or standard forms; there is no dedicated electronic trial portal.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic, relying on national coordination and spontaneous reporting.
Governance: The National Pharmacovigilance Centre operates within the FDD. Laos is a member of the WHO PIDM and contributes to VigiBase via VigiFlow.
Personnel & Infrastructure:
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Laos.
No PSMF Mandate: Marketing Authorization Holders (MAHs) do not need to register or maintain a Pharmacovigilance System Master File in the country.
Incident Reporting (ICSRs):
Reporting is spontaneous and voluntary.
Timelines: Not rigidly codified. The expectation is "prompt" reporting for serious or unexpected events (generally interpreted as 15 days).
Risk & Periodic Reporting:
PSURs: Not routinely mandatory. Safety updates may be requested during registration renewal or variations.
RMPs: Not a standard requirement; risk assessment is reactive.
Summary of Requirements
Component Requirement in Laos Regulatory Authority FDD (Food and Drug Department) National Centre National Pharmacovigilance Centre (within FDD) Local QPPV / PSMF Not required Safety Reporting Spontaneous; "Prompt" reporting Clinical Reporting SUSARs (Expedited); DSURs (on request) Regional Alignment WHO / ASEAN
In Laos, Pharmacovigilance is regulated by the Food and Drug Department (FDD) under the Ministry of Health. The system is basic and functional, operating under WHO minimum standards and ASEAN regional guidelines without a standalone national GVP law.
1. Clinical Safety (Clinical Trials)
Clinical trials require FDD authorization and adherence to international norms.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in rigid national statutes, the expectation aligns with ICH E2A and ASEAN standards:
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) or annual safety updates are typically required (ICH E2F format).
-
Submission: Reports are submitted directly to the FDD via email or standard forms; there is no dedicated electronic trial portal.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is minimalistic, relying on national coordination and spontaneous reporting.
-
Governance: The National Pharmacovigilance Centre operates within the FDD. Laos is a member of the WHO PIDM and contributes to VigiBase via VigiFlow.
-
Personnel & Infrastructure:
-
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance residing in Laos.
-
No PSMF Mandate: Marketing Authorization Holders (MAHs) do not need to register or maintain a Pharmacovigilance System Master File in the country.
-
-
Incident Reporting (ICSRs):
-
Reporting is spontaneous and voluntary.
-
Timelines: Not rigidly codified. The expectation is "prompt" reporting for serious or unexpected events (generally interpreted as 15 days).
-
-
Risk & Periodic Reporting:
-
PSURs: Not routinely mandatory. Safety updates may be requested during registration renewal or variations.
-
RMPs: Not a standard requirement; risk assessment is reactive.
-
Summary of Requirements
| Component | Requirement in Laos |
| Regulatory Authority | FDD (Food and Drug Department) |
| National Centre | National Pharmacovigilance Centre (within FDD) |
| Local QPPV / PSMF | Not required |
| Safety Reporting | Spontaneous; "Prompt" reporting |
| Clinical Reporting | SUSARs (Expedited); DSURs (on request) |
| Regional Alignment | WHO / ASEAN |