INOPP Forum
Pharmacovigilance requirements in Myanmar
Quote from VigiServe Admin on February 6, 2026, 1:50 PMIn Myanmar, Pharmacovigilance is regulated by the Department of Food and Drug Administration (FDA) under the Ministry of Health. The system is basic and developing, relying on WHO alignment and ASEAN regional standards without complex industry obligations.
1. Clinical Safety (Clinical Trials)
Clinical trials require FDA/MoH approval and adherence to international/ASEAN guidelines.
Expedited Reporting (SUSARs): Sponsors follow ICH E2A best practices:
Fatal or Life-Threatening: Within 7 days.
Other Serious Unexpected: Within 15 days.
Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates (ICH E2F format) may be required, particularly for multi-country trials.
Submission: Direct to FDA/MoH via forms or email; no national electronic portal exists.
2. Post-Marketing Pharmacovigilance
Post-approval requirements focus on national coordination and spontaneous reporting rather than strict MAH bureaucracy.
Personnel & Infrastructure:
Local QPPV: Not required.
PSMF: Not required.
Incident Reporting (ICSRs):
Reporting is driven by healthcare professionals and hospitals. MAHs are expected to report serious cases.
Timelines: Not rigidly fixed. "Prompt" reporting is encouraged for serious/unexpected events (ASEAN regional practice aligns with 15 days).
Risk & Periodic Reporting:
PSURs/PBRERs: Not routinely required. May be requested during registration renewal.
Risk Management Plans (RMPs): Not required as a standard; risk assessment is reactive.
Summary of Requirements
Component Requirement in Myanmar Regulatory Authority FDA (Department of Food and Drug Administration) Local QPPV Not required PSMF Not required SUSAR Reporting 7–15 days (Best practice/ICH aligned) ICSR Timelines "Prompt" (No fixed timeline) RMPs & PSURs On request only
In Myanmar, Pharmacovigilance is regulated by the Department of Food and Drug Administration (FDA) under the Ministry of Health. The system is basic and developing, relying on WHO alignment and ASEAN regional standards without complex industry obligations.
1. Clinical Safety (Clinical Trials)
Clinical trials require FDA/MoH approval and adherence to international/ASEAN guidelines.
-
Expedited Reporting (SUSARs): Sponsors follow ICH E2A best practices:
-
Fatal or Life-Threatening: Within 7 days.
-
Other Serious Unexpected: Within 15 days.
-
-
Periodic Reporting: Development Safety Update Reports (DSURs) or annual updates (ICH E2F format) may be required, particularly for multi-country trials.
-
Submission: Direct to FDA/MoH via forms or email; no national electronic portal exists.
2. Post-Marketing Pharmacovigilance
Post-approval requirements focus on national coordination and spontaneous reporting rather than strict MAH bureaucracy.
-
Personnel & Infrastructure:
-
Local QPPV: Not required.
-
PSMF: Not required.
-
-
Incident Reporting (ICSRs):
-
Reporting is driven by healthcare professionals and hospitals. MAHs are expected to report serious cases.
-
Timelines: Not rigidly fixed. "Prompt" reporting is encouraged for serious/unexpected events (ASEAN regional practice aligns with 15 days).
-
-
Risk & Periodic Reporting:
-
PSURs/PBRERs: Not routinely required. May be requested during registration renewal.
-
Risk Management Plans (RMPs): Not required as a standard; risk assessment is reactive.
-
Summary of Requirements
| Component | Requirement in Myanmar |
| Regulatory Authority | FDA (Department of Food and Drug Administration) |
| Local QPPV | Not required |
| PSMF | Not required |
| SUSAR Reporting | 7–15 days (Best practice/ICH aligned) |
| ICSR Timelines | "Prompt" (No fixed timeline) |
| RMPs & PSURs | On request only |