INOPP Forum
Pharmacovigilance Requirements in Barbados
Quote from VigiServe Admin on December 12, 2020, 2:44 PMIn Barbados, Pharmacovigilance is managed by the Barbados Drug Service (BDS) under the Ministry of Health & Wellness. The system is basic and relies heavily on regional support from the Caribbean Public Health Agency (CARPHA) and the VigiCarib platform rather than standalone national legislation.
1. Clinical Safety (Clinical Trials)
Clinical trials are limited in volume but require approval from the Ministry of Health and an Ethics Committee. Safety monitoring follows general international norms (ICH E2A):
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in a specific local act, the expectation aligns with international 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 for ongoing trials (ICH E2F or WHO format).
Submission: There is no electronic portal like EudraVigilance. Reports are submitted directly to the Ministry of Health or BDS via email or hard copy.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is largely voluntary and focuses on public sector reporting through polyclinics.
Personnel & Infrastructure:
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance.
No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File in Barbados.
Incident Reporting (ICSRs):
Reporting is spontaneous and voluntary.
Platform: Reports are submitted via the VigiCarib secure web application or standard hard-copy ADR forms.
Timelines: Not rigidly codified in law. The expectation is "prompt" reporting for serious or unexpected events (generally interpreted as 15 days).
Risk & Periodic Reporting:
PSURs: Not routinely mandatory. The BDS may request safety updates during registration renewal or if specific concerns arise.
Risk Management Plans (RMPs): Not a standard requirement. Risk assessment is reactive, supported by CARPHA.
Summary of Requirements
Component Requirement in Barbados Regulatory Authority Barbados Drug Service (BDS) Regional Support CARPHA / VigiCarib Local QPPV / PSMF Not required Safety Reporting Voluntary; via VigiCarib or forms SUSAR Reporting Expedited (7–15 days); submitted manually RMPs & PSURs On request only As part of our monitoring your doctor may report any reactions which you have to the medication
by completing an Adverse Drug Reaction Form or you can contact Barbados Drug Service, at 535-4300 or
drugservice@health.gov.bb, and tell us about it yourself.
In Barbados, Pharmacovigilance is managed by the Barbados Drug Service (BDS) under the Ministry of Health & Wellness. The system is basic and relies heavily on regional support from the Caribbean Public Health Agency (CARPHA) and the VigiCarib platform rather than standalone national legislation.
1. Clinical Safety (Clinical Trials)
Clinical trials are limited in volume but require approval from the Ministry of Health and an Ethics Committee. Safety monitoring follows general international norms (ICH E2A):
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in a specific local act, the expectation aligns with international 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 for ongoing trials (ICH E2F or WHO format).
-
Submission: There is no electronic portal like EudraVigilance. Reports are submitted directly to the Ministry of Health or BDS via email or hard copy.
2. Post-Marketing Pharmacovigilance
Post-approval surveillance is largely voluntary and focuses on public sector reporting through polyclinics.
-
Personnel & Infrastructure:
-
No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance.
-
No PSMF Mandate: Marketing Authorization Holders (MAHs) are not required to register or maintain a Pharmacovigilance System Master File in Barbados.
-
-
Incident Reporting (ICSRs):
-
Reporting is spontaneous and voluntary.
-
Platform: Reports are submitted via the VigiCarib secure web application or standard hard-copy ADR forms.
-
Timelines: Not rigidly codified in law. The expectation is "prompt" reporting for serious or unexpected events (generally interpreted as 15 days).
-
-
Risk & Periodic Reporting:
-
PSURs: Not routinely mandatory. The BDS may request safety updates during registration renewal or if specific concerns arise.
-
Risk Management Plans (RMPs): Not a standard requirement. Risk assessment is reactive, supported by CARPHA.
-
Summary of Requirements
| Component | Requirement in Barbados |
| Regulatory Authority | Barbados Drug Service (BDS) |
| Regional Support | CARPHA / VigiCarib |
| Local QPPV / PSMF | Not required |
| Safety Reporting | Voluntary; via VigiCarib or forms |
| SUSAR Reporting | Expedited (7–15 days); submitted manually |
| RMPs & PSURs | On request only |
As part of our monitoring your doctor may report any reactions which you have to the medication
by completing an Adverse Drug Reaction Form or you can contact Barbados Drug Service, at 535-4300 or
drugservice@health.gov.bb, and tell us about it yourself.