INOPP Forum
Pharmacovigilance requirements in Bhutan
Quote from VigiServe Admin on November 27, 2020, 1:10 PMIn Bhutan, Pharmacovigilance is overseen by the Bhutan Food and Drug Authority (BFDA) (formerly the Drug Regulatory Authority) under the Ministry of Health. The framework functions on a "basic to moderate" maturity level, aligning with WHO minimum requirements rather than complex, rigid legislation found in larger markets.
1. Clinical Safety (Clinical Trials)
Clinical trials are limited in volume but strictly regulated under the Medicines Act of the Kingdom of Bhutan 2005.
Approvals: Trials require authorization from both the BFDA and the relevant Ethics Committee.
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) expeditiously. While rigid national timelines aren't codified, the system follows international norms:
7 days for fatal/life-threatening cases.
15 days for other serious unexpected cases.
Routine Reporting: Annual safety updates or Development Safety Update Reports (DSURs) are typically required for ongoing trials (ICH E2F format).
Submission Method: There is no dedicated electronic portal (like EudraVigilance). Reports are submitted directly to the BFDA via email or paper forms.
2. Post-Marketing Pharmacovigilance
The system prioritizes spontaneous reporting and national coordination over heavy industry obligations.
Governance: Bhutan is a full member of the WHO Programme for International Drug Monitoring (PIDM). The National Pharmacovigilance Centre (NPC) at the BFDA collects data and contributes to VigiBase via VigiFlow.
Operational Requirements:
No Local QPPV: There is no explicit requirement for a local Qualified Person for Pharmacovigilance residing in Bhutan.
No PSMF Mandate: Companies do not need to register or locate a Pharmacovigilance System Master File in the country.
Incident Reporting:
Healthcare professionals and Marketing Authorization Holders (MAHs) report suspected Adverse Drug Reactions (ADRs) using standard forms.
Timelines: Reporting is "voluntary but encouraged." Serious or unexpected events must be reported promptly to enable signal detection, though no fixed legislative deadline (e.g., 15 days) is strictly enforced in public guidelines.
Risk & Periodic Reporting:
PSURs/PBRERs: Not routinely mandatory. The BFDA may request them during registration renewal or for specific safety concerns.
Risk Management Plans (RMPs): Not a standard requirement for all products.
Summary of Requirements
Component Requirement in Bhutan Regulatory Authority Bhutan Food and Drug Authority (BFDA) National Centre National Pharmacovigilance Centre (housed at BFDA) Local QPPV / PSMF Not required Safety Reporting Voluntary/Spontaneous; submitted via hard copy or email Clinical Trial Safety Expedited reporting of SUSARs; DSURs on request International Link Full member of WHO PIDM; uses VigiFlow National Pharmacovigilance Centre (DRA)
Royal Government of Bhutan P.O 1556
Bhutan
Telephone: +975 337075
Fax: +975 335803
E-Mail: ndem@dra.gov.bt
In Bhutan, Pharmacovigilance is overseen by the Bhutan Food and Drug Authority (BFDA) (formerly the Drug Regulatory Authority) under the Ministry of Health. The framework functions on a "basic to moderate" maturity level, aligning with WHO minimum requirements rather than complex, rigid legislation found in larger markets.
1. Clinical Safety (Clinical Trials)
Clinical trials are limited in volume but strictly regulated under the Medicines Act of the Kingdom of Bhutan 2005.
-
Approvals: Trials require authorization from both the BFDA and the relevant Ethics Committee.
-
Expedited Reporting: Sponsors must report Suspected Unexpected Serious Adverse Reactions (SUSARs) expeditiously. While rigid national timelines aren't codified, the system follows international norms:
-
7 days for fatal/life-threatening cases.
-
15 days for other serious unexpected cases.
-
-
Routine Reporting: Annual safety updates or Development Safety Update Reports (DSURs) are typically required for ongoing trials (ICH E2F format).
-
Submission Method: There is no dedicated electronic portal (like EudraVigilance). Reports are submitted directly to the BFDA via email or paper forms.
2. Post-Marketing Pharmacovigilance
The system prioritizes spontaneous reporting and national coordination over heavy industry obligations.
-
Governance: Bhutan is a full member of the WHO Programme for International Drug Monitoring (PIDM). The National Pharmacovigilance Centre (NPC) at the BFDA collects data and contributes to VigiBase via VigiFlow.
-
Operational Requirements:
-
No Local QPPV: There is no explicit requirement for a local Qualified Person for Pharmacovigilance residing in Bhutan.
-
No PSMF Mandate: Companies do not need to register or locate a Pharmacovigilance System Master File in the country.
-
-
Incident Reporting:
-
Healthcare professionals and Marketing Authorization Holders (MAHs) report suspected Adverse Drug Reactions (ADRs) using standard forms.
-
Timelines: Reporting is "voluntary but encouraged." Serious or unexpected events must be reported promptly to enable signal detection, though no fixed legislative deadline (e.g., 15 days) is strictly enforced in public guidelines.
-
-
Risk & Periodic Reporting:
-
PSURs/PBRERs: Not routinely mandatory. The BFDA may request them during registration renewal or for specific safety concerns.
-
Risk Management Plans (RMPs): Not a standard requirement for all products.
-
Summary of Requirements
| Component | Requirement in Bhutan |
| Regulatory Authority | Bhutan Food and Drug Authority (BFDA) |
| National Centre | National Pharmacovigilance Centre (housed at BFDA) |
| Local QPPV / PSMF | Not required |
| Safety Reporting | Voluntary/Spontaneous; submitted via hard copy or email |
| Clinical Trial Safety | Expedited reporting of SUSARs; DSURs on request |
| International Link | Full member of WHO PIDM; uses VigiFlow |
National Pharmacovigilance Centre (DRA)
Royal Government of Bhutan P.O 1556
Bhutan
Telephone: +975 337075
Fax: +975 335803
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