The Caribbean Regulatory System
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World Bank, Washington, DC
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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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Palabras clave
PUBLIC HEALTH COOPERATION, REGULATORY MEDICINE REVIEW PROCESS, PHARMACOVIGILANCE, PUBLIC HEALTH AGENCY ADMINISTRATION, PHARMACEUTICAL SURVEILLANCE, DRUG SAFETY