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 recently reviewed and recommended to CARICOM Member States its first reproductive health product, Levoplant. The product, made by Shanghai Dahua Pharmaceutical Co., Ltd., was prequalified by the World Health Organization on June 30, 2017, meaning it meets the United Nations standards of safety, efficacy, and quality for all its procurement programs. It has also been approved for country program purchase by the United Nations Population Fund. The CRS verified that the product the manufacturer intends to sell in CARICOM is the same as the prequalified version.
The active ingredient, levonorgestrel, prevents pregnancies by inhibiting or altering ovulation and thickening the cervical mucus. The product provides long term (up to 3 years of use) but reversible contraception, and becomes active when inserted into the upper arm. CARICOM Member States will now have an additional option for quality, affordable hormonal implants if they register this medicine.
On Wednesday, April 25th, the CARPHA/Caribbean Regulatory System (CRS) recommended its first vaccine to CARICOM states for marketing authorization/import permit.
The product, called Euvichol-Plus, is manufactured by EuBiologics Co., Ltd. of South Korea, and is intended to protect against cholera. It is a new type of cholera vaccine that is easier to deliver in challenging field conditions and is much less costly than previous alternatives.
Although cholera is often dealt with in the context of disasters, including recent outbreaks in the CARICOM state of Haiti, an effective vaccine is an important part of a comprehensive prevention package. This vaccine is prequalified by the World Health Organization (WHO) and meets WHO’s high standards for quality, safety and efficacy.
The CRS relied on assessment information confidentially shared by WHO, and verified documentation provided by the manufacturer to ensure it was the same product. This case demonstrates the way the CRS is facilitating access to high quality and life-saving medicines in the region.
In the context of limited human resources and financing in the many small states of CARICOM, the CRS is serving as a mechanism to rely on trusted authorities for their reviews of products regarding safety, quality, and efficacy, and providing a regulatory channel for manufacturers to expeditiously send these same high quality products to the region.
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
On December 20, 2017, the Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) launched VigiCarib, a voluntary regional system for CARICOM states to report medicines related adverse events (adverse drug reactions (ADRs)) and substandard and falsified products. Medicines safety and monitoring systems are often limited in the individual small states of CARICOM, and the rationale for a regional approach is that with pooling of resources, sharing of information, and coordination of activities, there will be efficiencies of scale that can lead to stronger systems overall.
VigiCarib is endorsed by Ministers of Health in CARICOM states and allows health professionals, the public, and other stakeholders to report to the CRS for regulatory analysis and action. The CRS may share information about problematic products with CARICOM states, pool data to identify signals, and make recommendations to governments about regulatory actions. The program will help to protect patients and bolster their confidence in health care, as well as send a signal to manufacturers and distributors that their products are being monitored for safety and quality.
Stakeholders can report via the word form, or online form but if pressed for time, can also work with the CRS to flag issues through abbreviated methods, such as taking photos and/or sending short recorded messages via email, that captures essential information, while the CRS works with the stakeholder to complete the necessary information on the case.
Information and reports should be sent to the CRS through the dedicated email: Vigicarib@carpha.org
Note that reports received will be copied to the government focal points and the national centers. The CRS will keep reporter identities anonymous at their request.
Educational and training activities will be announced on a dedicated web page that will be coming soon.
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