Pharmacovigilance Requirements Brief Overview

Trinidad and Tobago

Pharmacovigilance and medicine regulation in Trinidad and Tobago are administered by the Ministry of Health through the Chemistry, Food and Drugs Division (CFDD), under the Food and Drugs Act and Regulations, Chapter 30:01. The CFDD and its Drug Registration Unit oversee drug registration, product standards, regulatory compliance and post-market safety matters, while regional pharmacovigilance support is provided through CARPHA's Caribbean Regulatory System and VigiCarib network. Pharmaceutical-company representatives can submit suspected adverse drug reactions, quality defects and reports concerning substandard, falsified or unregistered products through the national or VigiCarib channels. For products recommended through the Caribbean Regulatory System, applicants should notify serious adverse reactions and relevant quality or falsification issues; serious unexpected reactions should be communicated urgently, and the CRS may request PSURs or PBRERs required by the reference authority. Publicly available national sources do not define a separate QPPV, PSMF or routine local aggregate-reporting schedule for every product. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): Effective Signal Management in Pharmacovigilance.

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