Quote from VigiServe Admin on November 28, 2020, 10:14 AM

In Jamaica, the pharmacovigilance system is managed by the Ministry of Health & Wellness (MOH) through the Standards and Regulation Division (SRD). The National Pharmacovigilance Centre (NPvC), known as PharmWatch Jamaica, serves as the central hub. The system is WHO-aligned and functional, though it relies heavily on voluntary reporting rather than strict industry mandates.

1. Clinical Safety (Clinical Trials)

Clinical trials are regulated by the SRD and must adhere to ICH GCP principles.

• Expedited Reporting: Sponsors are required to report Suspected Unexpected Serious Adverse Reactions (SUSARs) to the MOH.

  • 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 reports are required for ongoing trials.

• Submission: Reports go directly to the MOH via forms or email.

2. Post-Marketing Pharmacovigilance

There are no strict local obligations for Marketing Authorization Holders regarding local personnel or system master files, although monitoring is expected.

• 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 maintain a Pharmacovigilance System Master File.

• Incident Reporting (ICSRs):

  • Enforcement: Voluntary/Spontaneous reporting is encouraged via PharmWatch.

  • Timelines:

    • Serious: Within 15 calendar days.

    • Non-Serious: Within 90 calendar days.

• Risk & Periodic Reporting:

  • PSURs: Not routinely mandatory; typically only required upon request or during renewal.

  • RMPs: Reactive; may be requested for high-risk or new products.

Summary of Requirements

Component	Requirement in Jamaica
Regulatory Authority	MOH (Standards & Regulation Div.)
National Centre	NPvC (PharmWatch Jamaica)
Local QPPV / PSMF	Not required
Safety Reporting	15 days (Serious) / 90 days (Non-Serious)
Clinical Reporting	SUSARs (7/15 days - ICH Align)
Submission Language	English