Publication: The Caribbean Regulatory System: A Subregional Approach for Efficient Medicine Registration and Vigilance
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Date
2023-08-15
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2023-08-15
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This report focuses on the Caribbean Public Health Agency (CARPHA), one of the three multi-national public health agencies in the world, that commenced operations on Jan 1, 2013, with the aim of delivering the functions of five previous regional health institutions through one platform for greater synergy and cost-effectiveness and as the principal institutional expression of Caribbean Cooperation in Health. The activities of CARPHA include the provision of a subregional mechanism that supports regulatory action to ensure access to safe medicines, such as the subregional system for reporting adverse drug reactions (ADRs) and substandard and falsified products (VigiCarib), and the regional post marketing drug quality testing program under the CARPHA Medicines Quality Control and Surveillance Department. Another relevant CARPHA activity is reviewing new medicines which want to enter the Caribbean market. This was especially important during the COVID-19 pandemic, with the plethora of new vaccines. VigiCarib is a good example of a subregional approach to facilitate well-functioning post marketing monitoring activities, including PV. Although this is a relatively new program, it is well established, integrates lessons from more experienced regulatory authorities, and supports small economies without specific PV programs, thus helping ensure the safety, quality, and effectiveness of medicines and vaccines. VigiCarib can serve as a model in other parts of the world where a regional approach to strengthening regulatory systems is under consideration. However, a key lesson of the experience of CARICOM, is that regional initiatives are complex and require clear objectives, harmonization, respect for the individual countries and territories, and mutual trust.
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“Wang, Huihui; Extavour, Rian Marie; Marquez, Patricio V.; Bieliaieva, Kseniya. 2023. The Caribbean Regulatory System: A Subregional Approach for Efficient Medicine Registration and Vigilance. Pharmacovigilance and Essential Public Health Services Series. © World Bank. http://hdl.handle.net/10986/40207 License: CC BY-NC 3.0 IGO.”
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