The Caribbean Regulatory System (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).
The CRS derives its legal authority from CARPHA’s public health mandate , the Caribbean Pharmaceutical Policy , and various other Ministerial health frameworks and decisions.
CARICOM’s Technical Advisory Committee on Pharmaceutical Policy (TECHPHARM), made up of representatives from CARICOM Member States and institutions, advises the CRS on policy and technical matters.
The CARPHA Drug Testing Laboratory plays an integral role as well.
The main purpose of the CRS is to strengthen regulatory capacity in CARICOM Member States in support of improved access to safe, quality, efficacious, and affordable medicines and health technologies. The CRS strengthens regulatory capacities through the provision of registration and pharmacovigilance support to Member States, using efficiencies, such as reliance on reference authorities, to enable a sustainable enterprise in the resource-constrained environment of small states. This contributes to CARPHA’s mandate to prevent diseases, promote health and respond to public health emergencies.
Very broadly, the CRS carries out the following regulatory focus activities:
The operational policies of the CRS, including links to guidance on dossier submission requirements for registration, are laid out in the “CRS Operational Policy.”
BENEFITS TO INDUSTRY:
The CRS benefits industry in a variety of ways. It offers a central portal for access to CARICOM’s markets of over 17 million people.
For more background and context, please see the recent article “Regionalization as an approach to regulatory systems strengthening: a case study in CARICOM Member States” published in the Pan American Journal of Public Health.
For more information or submission inquiries, please contact: CRSRegistration@carpha.org
Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products
CARPHA/CRS recommends the medicines listed in this document to CARICOM member states for granting marketing authorization/import permit.
The CRS has requested countries/territories to provide officially nominated government focal points to engage with the CRS. The following are terms of reference for focal point responsibilities. Click here to read terms of reference.
CARICOM Ministers of Health issues a decision to implement the CRS in 2014 and have reaffirmed that decision in subsequent years
The CRS has also begun to pursue Memorandums of Understanding with individual states to further cement engagement. The below graphic shows the present state of this engagement
Note that the OECS Pharmaceutical Procurement Service signed an MOU so those participating countries are colored in.