Vigicarib

VigiCarib is a voluntary sub-regional system that the Member States of the Caribbean Community (CARICOM) use to report suspected adverse drug reactions (ADRs) and substandard or counterfeit medical products. In 2021, it incorporated the reporting of adverse events following immunisation (AEFIs).

The establishment of VigiCarib stems from the recognition that small States and markets face unique challenges in exercising essential regulatory functions, such as pharmacovigilance. On the one hand, having small populations leads to limited human resources and a smaller group of people with the necessary competence and experience. On the other, small States market a low volume of products that does not generate the commercial incentives to attract companies and manufacturers that can comply with stricter regulatory standards, so the pharmaceutical market in these countries is often dominated by intermediaries. (1)

Given this scenario, in 2011, CARICOM Ministers of Health adopted the Caribbean Pharmaceutical Policy. This policy establishes as one of its objectives the creation of the Caribbean Regulatory System (CRS). The CRS is a regionalization model that mitigates the difficulties of regulatory capacity in these small States by providing a single gateway to the CARICOM market, generating efficiencies by using decisions from other regulatory authorities, work sharing and using modern assessment criteria.

With the creation of the CRS in 2014, the voluntary system VigiCarib emerged with the objective of strengthening capacities to conduct pharmacovigilance in the region. VigiCarib also facilitates reporting to the WHO Global Surveillance and Monitoring System (GSMS) and the WHO Program for International Drug Monitoring (PIDM). This way, VigiCarib helps countries with limited resources to contribute to global surveillance and to receive information on international and regional trends.
VigiCarib provides its Member States electronic reporting forms for ADRs, AEFIs and substandard and falsified medical products. In addition, it coordinates a network of VigiCarib focal points, composed of representatives of CARICOM Member States and partners, which plays a key role in facilitating the exchange of information and experiences, as well as the reporting of ADRs, AEFIs and substandard and falsified medical products.

Between 2017 and 2021, VigiCarib has received 471 reports of suspected ADRs, AEFIs and substandard or falsified products. The majority (75%) are suspected ADRs and AEFIs, followed by substandard or falsified medical products (25%).
Promoting regulatory transparency and generation of information, the CRS periodically publishes a digital newsletter, VigiCarib News. In this newsletter, periodic sub-regional updates on ADRs, AEFIs and substandard and falsified medical products are shared with CARICOM countries.

Contacto:

For more information on VigiCarib contact VigiCarib@carpha.org

Useful links:

VigiCarib
Caribbean Regulatory System

Caribbean Pharmaceutical Policy

Link to document

Recursos Vigicarib

Washington, D.C.: Pan American Health Organization; 2021

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The aim of this document is to better understand the regulatory landscape of the Americas, with an emphasis on Latin American National Regulatory Authorities of Reference. Through this report, the Pan American Health Organization aims to increase the understanding of national regulatory remits and capacity in the Americas, raise awareness and appreciation of the regional regulatory progress and challenges, identify the regulatory issues emerging markets will bring, and highlight opportunities for evidence-based regulatory system strengthening.

Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, 24 to 26 October, 2018). Washington, D.C.: Pan American Health Organization; 2020.

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The aim of this document is to spotlight the regulatory challenges faced by small states with limited resources, especially in light of mandates to strengthen regulatory systems in the Americas and globally, and to ensure all peoples have access to quality medicines through the implementation of certain essential regulatory functions. It offers theoretical and practical advice about the adoption of key efficiencies to strengthen small state regulatory systems.

BMJ Glob Health. 2020;5(2):e001912. Published 2020 Mar 2. doi:10.1136/bmjgh-2019-001912

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The report describes the regulatory challenges of small states and recommendations on how they can build regulatory systems with a narrower scope that are less resource intensive and still ensure appropriate regulation and oversight. This model is currently being put in practice in the small states of the Caribbean Community and Pacific Islands and can inform other small states around the world.

Uppsala: Uppsala Monitoring Centre; 2020.

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For many national centres, the number of individual case safety reports (ICSRs) is relatively small, and the range of medicinal products and the event profiles may be unique to each location. This publication provides concise, structured guidance for signal management, primarily in national centres with small databases and limited resources.

Port of Spain, Trinidad and Tobago: Caribbean Public Health Agency: 2021.

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This document presents an algorithm which is intended to assist Member States that are unable to assess and test vaccines directly with the decisions for procurement / registration for emergency use (EU), in light of offers by market authorization holders (MAHs) of COVID19 vaccines.

Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, 24 to 26 October, 2018). Washington, D.C.: Pan American Health Organization; 2019.

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The aim of this document is to outline key examples and principles for the practice of regulatory reliance. It builds on a presentation that was made at the 2016 Conference and integrates global thinking on the subject, including a recent document by the World Health Organization (WHO). The overarching goal is to ensure that PANDRH stakeholders continue to build understanding around reliance in ways that can better inform scenarios for its use.

Washington, D.C.: Pan American Health Organization; 2020.

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The aim of this report is to furnish guidance and recommendations to support regulatory decision-making in pharmacovigilance, technovigilance, and hemovigilance during pandemics in the Region of the Americas. It addresses key issues regarding the detection, prevention, and response to unregistered, substandard, or falsified medical products in this context. .

Rev Panam Salud Publica. 2016;39(5):262–68.

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This report describes the Caribbean Regulatory System (CRS), a regionalization initiative being implemented in the mostly small countries of the Caribbean Community and Common Market (CARICOM). This initiative is an innovative effort to strengthen regulatory systems in the Caribbean, where capacity is limited compared to other subregions of the Americas. It can serve as a case study for the development of similar regulatory strengthening initiatives in resource-constrained environments.

Port of Spain, Trinidad, and Tobago: CARPHA; 2019

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This guide provides information to CARPHA Member States on the conduct of post-market surveillance and the procedures for medicines quality testing at the Medicines Quality Control and Surveillance Department (MQCSD). It aims to assist national medicines regulatory authorities of CARPHA Member States and associates in the design and conduct of programs for national post-market surveillance of medicines and describes the procedures for sample collection, and the submission of samples of medicines for compendial testing to the MQCSD.

Port of Spain, Trinidad and Tobago: Caribbean Public Health Agency; 2021.

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This document describes the procedure used for verification review of medical products developed for the prevention, diagnosis, treatment (including investigational use) of the novel coronavirus 2019 (COVID-19). Medical products referred to in this document are: medicines, vaccines, and in vitro diagnostics (IVDs). Antibody tests will only be considered based on the recommendations of the World Health Organization.

Vigicarib News

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