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
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
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.
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40th Medicine Recommended to CARICOM Governments
CARPHA's Caribbean Regulatory System (CRS) recently recommended its 40th medicine to CARICOM governments. “This is an important milestone for the CRS because it shows that manufacturers are increasingly using the system and it can work” said Dr. Virginia Asin, who oversees the program as the Director, Surveillance, Disease Prevention and Control at CARPHA. The updated list of recommended medicines is publicly available on CARPHA’s webpage.
The CRS assists the small states of CARICOM with the resource- and time-intensive task of evaluating medicines for safety, quality, and efficacy. Its approach requires that all medicines reviewed are already approved by a PAHO-designated reference authority, the European Union, or WHO Prequalification program. Once confirmed as eligible, the medicines intended for the CARICOM markets are verified as the same. Internal data show that the medicines available in highly regulated markets are not necessarily the same products that are sold in CARICOM.
Because the CRS is voluntary, manufacturers determine the products that they submit, but medicines should be listed on the WHO Essential Medicine List or be of public health value to the region. An increasing percentage of the recommended medicines treat non-communicable diseases (about 25% currently), which make up a large disease burden in CARICOM countries. Other products that are important to public health are included, such as antibiotics and antiretrovirals. The CRS recently recommended an innovative cure and an essential medicine to treat Hepatitis C that is not currently registered anywhere in the region.
The process of review by the CRS typically takes about 6-8 weeks from receipt of documents to decision-making and recommendation to CARICOM governments. This has been found to be much faster than the current timelines in the region. This accelerated processing also enables faster access to essential quality medicines for patients.
Recently, the CARPHA/CRS recommended Gilead's Epclusa (sofosbuvir 400mg/velpatasvir 100mg) film-coated tablet for the treatment of Hepatitis C.
The product is the first combination of its kind, and is listed on the WHO Essential Medicine List. It is also a first line therapy as recommended by WHO. The rationale for such an important status is that Epclusa is curative for all genotypes of Hepatitis C. If not treated, Hepatitis C can lead to negative health outcomes like liver failure and cancer.
This is a significant development for patients in CARICOM because there are estimated to be perhaps 100,000 cases of Hepatitis C in the region, but few authorized treatments. Epclusa, for example, does not have marketing authorization in any CARICOM state. It is also significant for public health. Cures such as this one are critical to strategies to eliminate Hepatitis C in the Americas.
Patients need access to these innovative therapies quickly, and major manufacturers are increasingly using the CRS because of the efficiencies it brings in speeding access to medicines. The CARPHA/CRS pools CARICOM markets together and offers a single portal of entry to the region's 17 million people with one set of internationally recognized standards, and accelerated and transparent timelines. It is a major improvement over the current status quo in regulation of medicines, where products can take years to receive approval in the different national systems of CARICOM.
The list of recommended products is growing by the month and can be found HERE
High Blood Pressure and Cancer Medicines on CARPHA Caribbean Regulatory System Recommendation List
The Caribbean Regulatory System (CRS) recently recommended its first non-communicable disease (NCD) medicines, including amlodipine for high blood pressure and anastrozole for breast cancer. The Caribbean is the worst affected sub-region in the Americas for NCDs, which are a leading cause of premature mortality, making up about half of all deaths of people under 70.
The recommended medicines are some of the most important tools that health providers and patients have to correct dangerous conditions like high blood pressure and cancer. For example, amlodipine is recognized as a critically effective blood pressure lowering medicine and is one of the most highly purchased products in the sub-region. Anastrozole is a key treatment in breast cancer and is listed on the World Health Organization's (WHO) list of essential medicines.
Commenting on the development Dr. Virginia Asin-Oostburg, Director of Surveillance, Disease Prevention and Control at CARPHA who manages the CRS programme said, "This marks an important new milestone for assuring quality NCD medicines in the region, where we know regulatory capacity can be limited due to small populations and few human resources.“ She further noted that each medicine has to be pre-approved by a strong regulatory authority like the United States Food and Drug Administration or the World Health Organization, and be suitable for the Region, before it can be recommended by the CRS to CARICOM member states.
CARPHA/CRS Successes in Guyana Highlighted at WHO Conference
Guyana’s successes related to regulatory strengthening was recently highlighted by the Director of the Guyana National Regulatory Authority, Marlan Cole, at the biannual WHO International Conference of Drug Regulatory Authorities (ICDRA) in Dublin, Ireland.
Director Cole indicated that a key to Guyana’s strategy has been to rely on the Caribbean Public Health Agency's Caribbean Regulatory System's (CARPHA/CRS) recommendations for market authorization of imported medicines, seeking approval in Guyana. This has decreased the workload on the national regulatory staff and permitted faster market entry of quality products.
In addition, the CRS has not issued recommendations for unqualified products, effectively filtering lower quality medicines from entering the Guyana market. Director Cole stated the CRS has been valuable in helping to improve market surveillance.
A recent workshop for CARICOM States on use of the WHO Global Surveillance and Monitoring Systems for Substandard and Falsified products, revealed an unregistered and falsified biosimilar on the Guyana market. The implicated company is now facing enforcement action. Director Cole said that part of the country’s success in implementing the CRS was educating the local industry and maintaining a public health position in the face of a court challenge by one company.
According to CARPHA’s Director, Dr James Hospedales, "The CRS is a great example of how CARPHA is delivering needed public health services to CARICOM member states, and the collaboration with Guyana is a model for others.” He also said that "The mechanism will only gather strength over time, as awareness and uptake builds."
CARPHA/CRS and The Organization of Eastern Caribbean States/Pharmaceutical Procurement Service Form Partnership
The Organization of Eastern Caribbean States/Pharmaceutical Procurement Service (OECS/PPS) is announcing a new partnership with the Caribbean Public Health Agency/ Caribbean Regulatory System (CARPHA/CRS) that will require all anti-retroviral (ARVs) medicines to receive approval by the CRS in order to participate in the upcoming OECS/PPS ARV tender in June of 2019.
The CRS is a regional regulatory mechanism, endorsed by Ministers of Health from CARICOM states, that is implemented in technical collaboration with the Pan American Health Organization/World Health Organization (PAHO/WHO). The CRS seeks to increase the number of quality products on the CARICOM market through reliance on a select group of reference authorities for medicines approvals, including the US Food and Drug Administration and WHO Prequalification Program.
The OECS/PPS partnership with CRS will ensure that regulatory assurance can be provided to these vital and essential medicines, and that it can be done in a sustainable way that leverages the knowledge and expertise of local institutions. Suppliers will be invited to submit applications for ARVs on the OECS/PPS formulary HERE, and in accordance with CRS requirements, which can be found HERE.
For more information, please contact the OECS/PPS at: firstname.lastname@example.org or CRS at: CRSregistration@CARPHA.org
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