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 plays an integral role, including thorough post market surveillance.
The CRS helps states perform key regulatory functions. The CRS does this using efficiencies, such as reliance on reference authorities and a focus on essential medicines, 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:
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
CARICOM Ministers of Health issued 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 coloured in.
CARPHA/CRS recommends the medicines listed in this document to CARICOM member states for granting marketing authorization/import permit.
The CARPHA/CRS participated in a regional PAHO- sponsored meeting on Access to Medicines in Port of Spain, Trinidad and Tobago October 11-12, 2017. Delegations of government health and procurement officials from Bahamas, Belize, Guyana, Jamaica, the Organization of Eastern Caribbean States, Suriname, and Trinidad and Tobago attended, and discussed a variety of pressing issues including quality, price, procurement, and other supply chain challenges. The group will continue to meet and work on common challenges, including related to improving access to strategic and high cost medicines through a variety of mechanisms, including use of the PAHO Strategic Fund, and the CARPHA CRS.
National Regulatory Authority of Guyana Grants Marketing Authorization for a CARPHA CRS Recommended Medicine
A CARPHA/CRS recommended medicine was recently granted marketing authorization by the National Regulatory Authority of Guyana, signifying the first time ever a CARICOM Member State has done this in the history of the newly created mechanism. The product, a 1st line triple-fixed dose combination therapy for HIV, manufactured by Mylan, was fast-tracked for marketing authorization through a voluntary agreement between Guyana and CARPHA. The total time from receipt of the application by the CRS to marketing authorization by Guyana was 3 months or 90 calendar days. This is a much improved timeline over what currently exists in many Caribbean countries, where limited resources hamper regulatory activities, sometimes taking years for products to gain the legal approval needed for access by patients. The CARPHA/CRS recommends only essential medicines that have already been approved by a reference regulatory authority, such as WHO or the US Food and Drug Administration, and encourages Member States to grant marketing authorization to these products within 60 calendar days. It is part of a broader effort by partners, including PAHO/WHO, and the Bill and Melinda Gates Foundation, to strengthen regulatory capacity in the region, and improve timely access to strategic and high cost medicines for patients.
The CRS currently accepts dossiers for finished products already given at least one marketing authorization by the following Pan American Health Organization (PAHO) designated National Regulatory Authorities of Regional Reference (NRA/RR). These authorities have been assessed by PAHO to meet reference standards in accordance with PAHO Directing Council Resolution CD50.R9; NRAs/RR provide capacity building support to other regulatory authorities in the region. NRAs/RR include the countries:
For more information on specific requirements and other related information (such as lists of importers, where available), please contact the CRS. The CRS recommends that applicants submitting dossiers begin the process of identifying an importer as soon as possible so that there is no delay upon any recommendation for marketing authorization.
Note that currently only 5 countries that conduct Marketing Authorization:
Trinidad and Tobago
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.
Marketing Authorization of Pharmaceutical Products with Special Reference to Multisource (Generic) Products