Port of Spain, Trinidad and Tobago. 17 June 2025. The Caribbean Public Health Agency (CARPHA) continues to play a vital role in strengthening public health protection across CARICOM Member States through its Caribbean Regulatory System (CRS). This system supports countries by streamlining the registration and import approval process for medicines and vaccines, and by monitoring the quality and safety of medical products.
Since launching in 2017, the CRS has recommended 353 medical products, including 13 so far in 2025, for market authorisation or emergency use. It has also shared 742 product safety reports with Member States, helping them detect and respond to suspected side effects, vaccine reactions, and poor-quality or counterfeit products.
Dr. Lisa Indar, CARPHA’s Executive Director said, “The CRS enables CARICOM countries to access safe, high-quality medicines faster, while using fewer national resources.”
Explaining the value of CRS to The Bahamas, Dr. Gina A. Archer, Chief Pharmacist, Ministry of Health declared, “The CRS was extremely important and instrumental to us during the COVID-19 pandemic, particularly in guiding the selection of safe, efficacious, and quality-assured vaccines from numerous donors and potential suppliers. The product recommendations helped us navigate a complex global landscape and ensured we only accepted vaccines from trusted sources, ultimately protecting public health”. Dr Archer added, “The Bahamas continues to benefit from CRS outputs such as the VigiCarib newsletters”, which she said helps to keep them informed of regional pharmacovigilance developments.
Ms. Tandeka Barton, Ag. Director, Government Analyst Food and Drug Department, Guyana echoed similar appreciation for the VigiCarib newsletters, which helped them to stay alert to emerging risks while building a stronger culture of monitoring and safety in the country’s post-market activities.
Ms. Barton was high in praise for the CRS and stated, “Guyana has actively utilised the Caribbean Regulatory System (CRS) since October 2017 and, to date, the Department has registered 164 CRS-Recommended products. The CRS pathway, which operates in parallel with the Government Analyst Food and Drug Department’s (GA-FDD) national registration process, has provided an efficient alternative for applicants, particularly during periods of high workload, when meeting the 120-day processing timeline may be challenging.
The CRS is expert-driven and facilitates a transparent review process whereby all medical product submissions are reviewed by a team of qualified experts, who follow strict rules on confidentiality and conflicts of interest. Companies are asked to provide information about a product’s quality, safety and efficacy and may be asked to provide more information during the process, if necessary. At the end of the review, CRS provides a detailed assessment report, which is also shared with CARPHA Member States to support informed decisions.
When a product is recommended by CRS, Member States can decide whether to register or import the product based on CRS’ recommendations. Therefore, when a Member State decides to register or import the product, manufacturers must follow the country’s guidelines and processes for import and/or registration strictly. CRS reviews any changes to the product after a recommendation has been issued, which must be approved to maintain an active recommendation status. If companies fail to comply with CRS’ guidelines regarding notification of product changes for recommended products, this may lead to a suspension or withdrawal of the recommendation.
Several Member States have registered medicines and vaccines based on CRS’ recommendation for example, Guyana (164 products), Haiti (5 products) and The Bahamas (2 products).
To support efficient and good regulatory practices, the CRS has launched innovative digital platforms:
- CRS Gateway: A secure online portal for submitting and managing product applications and;
- CARPHA DHIS2 Modules: A digital tool for capturing quality and safety reports across healthcare systems in CARPHA Member States.
The CRS is staffed by a qualified, focused team including a Programme Manager, Technical Officer and Administrative Assistant—ensuring continued, high-quality support to Member States.
The CRS plays a crucial role in medicine and vaccine regulation, however, it does not set standards for drug purchasing or procurement. CARPHA remains committed to working with CARICOM countries to ensure that medicines and vaccines used across the region are safe, effective, and of high quality.
The Caribbean Regulatory System (CRS)
CRS is an initiative of the Caribbean Community and Common Market (CARICOM) and is managed as a regulatory unit within CARICOM’s regional public health body, the Caribbean Public Health Agency (CARPHA). It is supported by a number of partners, including the Pan American Health Organization/World Health Organization (PAHO/WHO), PAHO designated National Regulatory Authorities of Regional Reference (NRA/RR) (Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, United States), and the Bill and Melinda Gates Foundation (BMGF).
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