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).

Medicines and Vaccines:

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

  Medicines Vaccines
Countries / Agencies of Recognized RAs

Non-biologic medicines:

Argentina, Australia, Brazil, Canada, Chile, Colombia, European Union / European Medicines Agency, Japan, Mexico, Switzerland, United States of America, United Kingdom
Australia, Canada,
European Medicines Agency, Switzerland, United Kingdom, United States of America

Biologic medicines:

Canada, European Union / European Medicines Agency, Japan, Switzerland, United States of America, United Kingdom

Test Kits (In vitro diagnostics):

The test kit must be included in the World Health Organization’s Emergency Use Listing (EUL) for in vitro diagnosis of SARS-CoV-2 infection (COVID-19).

WHO Collaborative Procedures

The CRS participates in the WHO Collaborative Procedure for accelerated registration of prequalified medicines and vaccines, and the Facilitated Procedure for in vitro diagnostics. This approach is applied to medicines, vaccines and test kits, granted approval for emergency use listing, where applicable, whereby the CRS submits the required confidentiality agreement to the WHO.

The eligibility and technical requirements may be found at  CRS Requirements for EU authorized product reviews 11 2021.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:

Pharmacovigilance of COVID-19 Vaccines and Medicines

The Caribbean Regulatory System assists CARICOM and CARPHA Member States in monitoring the safety and quality of medicines and vaccines through its system of voluntary reporting. After using a COVID-19 medicine or getting a COVID-19 vaccine, persons who experience an unexpected side effect or reaction should seek medical care, and inform the health worker of the use of any recent medicines or vaccines. Health professionals, sponsors, patients, and caregivers may submit case reports to VigiCarib, which will be sent to the respective Ministries of Health of the Member State. From there the national authority will follow up according to national policies. Reporting of these events will help national authorities and global systems to identify previously unknown safety issues, or issues that may be unique to certain populations.

Please see the links to reporting forms in the list below.