INOPP Forum
Pharmacovigilance requirements in Maldives
Quote from VigiServe Admin on February 8, 2026, 4:51 AMThe Maldives pharmacovigilance system is coordinated by the Maldives Food and Drug Authority (MFDA) via the Medicine and Therapeutic Goods Division (MTG). Relying exclusively on imported medicines, the Maldives prioritizes post-marketing surveillance, spontaneous reporting, and Good Reliance Practices. The Maldives is a full member of the WHO Programme for International Drug Monitoring and utilizes WHO-UMC tools, including VigiFlow and VigiBase.
1. Post-Marketing Pharmacovigilance
Requirements are established by the Guideline on Pharmacovigilance and Adverse Drug Reaction Reporting (Version 2, March 2026) and the Guideline on Good Reliance Practices for Regulation of Medicines.
Personnel & Infrastructure:
Local Responsible Person: Required. Authorized local importers or representatives act as the primary contacts for safety monitoring and regulatory liaison.
System Documentation: A local Pharmacovigilance System Master File is not mandated. Global Marketing Authorization Holders maintain their own centralized systems.
Incident Reporting (Individual Case Safety Reports):
Timelines: Prompt reporting is required for serious and unexpected adverse drug reactions and adverse events following immunization. This is generally expected within 15 calendar days.
Submission: Reports are submitted using the official MFDA reporting form (Annex 1 of the guidelines) and entered into VigiFlow.
Risk & Periodic Reporting:
Periodic Benefit-Risk Evaluation Reports: Not subject to routine local schedules. They are submitted upon request, during registration renewals, or if triggered by specific safety signals.
Risk Management Plans: Reliance-based. Under Good Reliance Practices, applicants must provide a copy of the Risk Management Plan approved by a recognized Reference Regulatory Authority during product registration.
2. Clinical Safety (Clinical Trials)
Clinical trials are exceptionally rare in the Maldives. Any authorized research must adhere to strict ethical oversight and ICH-GCP standards.
Expedited Reporting: Sponsors report Suspected Unexpected Serious Adverse Reactions (SUSARs).
Fatal or Life-Threatening: Within 7 calendar days.
Other Serious Unexpected: Within 15 calendar days.
Submission: Direct submission to the MFDA and relevant ethics committees.
Summary of Requirements
Component Requirement in the Maldives Regulatory Authority MFDA (Maldives Food and Drug Authority) Framework ADR Guidelines (2026) / WHO Local Qualified Person for Pharmacovigilance Yes (Local Importer/Representative) Pharmacovigilance System Master File No Safety Reporting Prompt (15 days for Serious) Clinical Reporting SUSARs (7/15 days) Submission Language English
The Maldives pharmacovigilance system is coordinated by the Maldives Food and Drug Authority (MFDA) via the Medicine and Therapeutic Goods Division (MTG). Relying exclusively on imported medicines, the Maldives prioritizes post-marketing surveillance, spontaneous reporting, and Good Reliance Practices. The Maldives is a full member of the WHO Programme for International Drug Monitoring and utilizes WHO-UMC tools, including VigiFlow and VigiBase.
1. Post-Marketing Pharmacovigilance
Requirements are established by the Guideline on Pharmacovigilance and Adverse Drug Reaction Reporting (Version 2, March 2026) and the Guideline on Good Reliance Practices for Regulation of Medicines.
-
Personnel & Infrastructure:
-
Local Responsible Person: Required. Authorized local importers or representatives act as the primary contacts for safety monitoring and regulatory liaison.
-
System Documentation: A local Pharmacovigilance System Master File is not mandated. Global Marketing Authorization Holders maintain their own centralized systems.
-
-
Incident Reporting (Individual Case Safety Reports):
-
Timelines: Prompt reporting is required for serious and unexpected adverse drug reactions and adverse events following immunization. This is generally expected within 15 calendar days.
-
Submission: Reports are submitted using the official MFDA reporting form (Annex 1 of the guidelines) and entered into VigiFlow.
-
-
Risk & Periodic Reporting:
-
Periodic Benefit-Risk Evaluation Reports: Not subject to routine local schedules. They are submitted upon request, during registration renewals, or if triggered by specific safety signals.
-
Risk Management Plans: Reliance-based. Under Good Reliance Practices, applicants must provide a copy of the Risk Management Plan approved by a recognized Reference Regulatory Authority during product registration.
-
2. Clinical Safety (Clinical Trials)
Clinical trials are exceptionally rare in the Maldives. Any authorized research must adhere to strict ethical oversight and ICH-GCP standards.
-
Expedited Reporting: Sponsors report Suspected Unexpected Serious Adverse Reactions (SUSARs).
-
Fatal or Life-Threatening: Within 7 calendar days.
-
Other Serious Unexpected: Within 15 calendar days.
-
-
Submission: Direct submission to the MFDA and relevant ethics committees.
Summary of Requirements
| Component | Requirement in the Maldives |
| Regulatory Authority | MFDA (Maldives Food and Drug Authority) |
| Framework | ADR Guidelines (2026) / WHO |
| Local Qualified Person for Pharmacovigilance | Yes (Local Importer/Representative) |
| Pharmacovigilance System Master File | No |
| Safety Reporting | Prompt (15 days for Serious) |
| Clinical Reporting | SUSARs (7/15 days) |
| Submission Language | English |