Quote from VigiServe Admin on November 27, 2020, 1:58 PM

 

In Brunei, Pharmacovigilance is a basic, functional system regulated by the Brunei Darussalam Medicines Control Authority (BDMCA) under the Ministry of Health. Operations are aligned with WHO minimum standards and ASEAN regional guidelines, rather than a standalone national GVP legislation.

1. Clinical Safety (Clinical Trials)

Clinical trials are rare in Brunei. When they occur, they require strict regulatory and ethical approval.

• Approvals: Trials must be approved by the BDMCA and the Medical and Health Research Ethics Committee (MHREC).

• Expedited Reporting: Sponsors are expected to report Suspected Unexpected Serious Adverse Reactions (SUSARs). While not codified in rigid national regulations, the expectation aligns with ICH E2A/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 updates are typically required for ongoing trials (ICH E2F format).

• Submission: Reports are submitted directly to the BDMCA/Ministry of Health via email or hard copy; no electronic portal exists.

2. Post-Marketing Pharmacovigilance

Post-approval surveillance is minimalistic, relying on national coordination and spontaneous reporting rather than MAH-driven compliance.

• Governance: The National Pharmacovigilance Centre (NPC) is located at RIPAS Hospital. It collects data and contributes to VigiBase (Brunei is a WHO PIDM member since 2011).

• Personnel & Infrastructure:

  • No Local QPPV: There is no requirement for a local Qualified Person for Pharmacovigilance.

  • No PSMF Mandate: Marketing Authorization Holders (MAHs) do not need to register or maintain a Pharmacovigilance System Master File in Brunei.

• Incident Reporting (ICSRs):

  • Reporting is spontaneous and relies heavily on healthcare professionals.

  • 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.

  • Risk Management Plans (RMPs): Not a standard requirement; risk assessment is reactive.

Summary of Requirements

Component	Requirement in Brunei
Regulatory Authority	BDMCA (Brunei Darussalam Medicines Control Authority)
National Centre	National Pharmacovigilance Centre (RIPAS Hospital)
Local QPPV / PSMF	Not required
Safety Reporting	Spontaneous; "Prompt" reporting expected
Clinical Reporting	SUSARs (Expedited); DSURs (on request)
Regional Alignment	ASEAN / WHO