CRS Role During the Pandemic
The Caribbean Regulatory System (CRS) supports CARICOM Member States’ efforts to save lives during the COVID-19 pandemic by expediting the review of COVID-19 related treatments, vaccines and diagnostic kits, to make recommendations of quality-assured products for emergency use.
CRS Recommended products for COVID-19
The CRS will accept applications for review of medical products granted emergency use authorization or the equivalent by a trusted authority of reference: medicines, vaccines, in vitro diagnostics (test kits).
The medical product must meet one of the following criteria:
Be included in the WHO Emergency Use List (EUL) for prevention, treatment or in vitro diagnosis of COVID-19; or
Be granted authorization for emergency use for prevention, treatment or diagnosis of COVID-19 by one of the national regulatory authorities of reference based on type of product shown in Table 1.
Table 1: Regulatory Authorities of Reference (Reference Authorities) by Product Type
||In Vitro Diagnostics
|Countries / Agencies of Recognized RAs
||Argentina, Australia, Brazil, Canada, Chile, Colombia, Cuba, European Union / European Medicines Agency, Mexico, United States of America, United Kingdom
European Medicines Agency, Switzerland, United Kingdom, United States of America
Australia, Canada, Japan, Singapore, United States of America
The eligibility and technical requirements may be found at CRS Requirements for EU authorized product reviews 12 2020.pdf.
The CRS reserves the right to update the list of reference authorities in the future, including for example, factor in new assessment results by the Pan American Health Organization (PAHO) for National Regulatory Authorities of Regional Reference (NRA/RRs).
VigiCarib Vaccine AEFI Form at: https://form.jotform.co/210037487099865
Other trusted sources of information