The Caribbean Regulatory System (CRS)

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).


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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: 

  • *Conducts abbreviated reviews of product dossiers for safety, quality, and efficacy of medicines and vaccines that meet the following CRS eligibility criteria, including:
    • 1) the product has a current approval/registration/marketing authorization from a CRS-designated “reference authority” (national regulatory authority of Argentina, Brazil, Canada, Chile, Colombia, Cuba, European Union, Mexico, United States or WHO prequalification); and
    • 2) the product is named on the most recent version of the WHO Essential Medicine List (here) or PAHO Strategic Fund (here) - this includes innovative and generic medicines, and vaccines;"
  • *Recommends all favourably reviewed products to CARICOM Member States, and requests completion of in-country processes to grant approval/registration/marketing authorization/import permit within 60 calendar days,
  • *Carries out pharmacovigilance and post market surveillance of medicines and vaccines in the region.


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.

  • *These Member States are:
    • Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, Grenada, Guyana, Haiti, Jamaica, Montserrat, Saint Lucia, St. Kitts and Nevis, St. Vincent and the Grenadines, Suriname, and Trinidad and Tobago
  • *Associate Member States are:
    • Anguilla, Bermuda, British Virgin Islands, Cayman Islands, and Turks and Caicos Islands
  • *Because these countries are diverse and have different regulatory requirements and timelines for processing, the CRS benefits companies by giving them one streamlined set of requirements and a known and accelerated timeline for processing compared to what currently exists.
  • *The requirements are based on an abbreviated and accelerated procedure WHO uses for Prequalification when a product has already been registered by a reference authority.
  • *The CRS also participates in the WHO Collaborative Procedure, whereby sponsors that hold a prequalified product can authorize the release of corresponding assessments and inspectional information, to the CRS for review.


For more background and context, please see the recent articleRegionalization 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:

Operational Policy

Glossary of Key Terms 
  • An applicant or sponsor is the person or company who submits an application or dossier for marketing authorization of a new medicine, an update to an existing marketing authorization, or a variation to an existing marketing authorization.
  • Finished product
    • A product that has undergone all stages of manufacture, including packaging in its final container and labelling.
    Marketing authorization and registration


    • Marketing authorization is an official document issued by the competent national medicines regulatory authority for the purpose of marketing a product after evaluation for safety, efficacy, and quality. Once a product has been given marketing authorization, it is included in a list of authorized products—the register—and is often said to be “registered” or have a “registration."
    • The CRS uses the term “registration” instead of “marketing authorization” in that both terms imply the same regulatory review, but only a sovereign country can authorize products for sale in their market.
    • Medicine
      • Any substance or pharmaceutical product for human use that is intended to modify or explore physiological systems or pathological states for the benefit of the recipient.
Accountability, Confidentiality, Conflict of Interest, and Transparency 
  • CRS staff obey a code of conduct including observe guidelines on confidentiality and conflict of interest.
  • Consultants such as expert advisors obey guidelines on confidentiality and conflict of interest and are required to make a confidentiality undertaking and declaration of conflict of interest known as an “Agreement for Performance of Work” or “APW”.
  • CRS registration recommendations are made public on the CARPHA website.
  • The CRS publishes other relevant regulatory information on the CARPHA website. Relevant information may include key policies, guidelines, decisions, and performance metrics.
Eligibility Criteria 

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:    

    • Argentina,  Brazil, Canada, Chile, Colombia, Cuba, Mexico, and United States of Americia
    • The CRS also accepts dossiers for products already given marketing authorization in the European Union. This is because of the close historical and cultural ties to countries in the Caribbean.
  • Together, these authorities are referred to as “Reference Authorities” or “RAs”.
    • The CRS reserves the right to modify the list of RAs in the future, including for example, factor in new assessment results by PAHO for NRA/RR.
    • The CRS also accepts dossiers for finished products prequalified by the World Health Organization (WHO).
    • All products must be listed on the most recent versions of the WHO Essential Medicines List (here) or PAHO Strategic Fund (here).
Submitting a Dossier 


Screening of Dossiers Submitted 
  • Each product dossier submitted by a sponsor is screened for completeness against the list of required documentation before being assessed.
  • The CRS conducts two screenings of dossiers. The first is a preliminary or pre-screening of the dossier to check that all required documentation is submitted. This may be done with the sponsor present. If documentation is missing at this stage, the CRS will send a communication to the applicant and request a 10 business day turnaround time. The second is a more in depth screening to check that the submitted material is sufficiently comprehensive and of high quality for the CRS to proceed to assessment.
  • Dossiers that are considered complete as the result of screening processes are retained for assessment by the CRS.
  • If the dossier is accepted for assessment, the sponsor is informed of this by written communication. This serves as an agreement between the CRS and the sponsor for the participation in the CRS review and a commitment to comply with the provisions of the CRS review process.


Dossier Assessment 
  • The product information submitted in the dossiers is assessed by a multidisciplinary team of experts
  • The assessors must comply with conditions of appointment, as well as confidentiality and conflict of interest rules of the CRS.
  • The CRS may ask questions of the sponsor during the assessment stage.
  • The CRS provides an assessment report to the sponsor following the assessment.
  • The CRS reserves the right to share the assessment report and relevant documentation, including the product summary characteristics, with any interested authorized CARICOM member state.
    Site Inspection 
    • The CRS expects that sponsors comply with Good Manufacturing Practices (GMP) and this is assessed through correspondence and verification of GMP with RAs. The CRS reserves the right to conduct site inspections.


    Meeting with Sponsors 
    • The CRS reserves the right to request meetings with sponsors at any time.
    • Meetings requested by sponsors are granted at the discretion of the CRS.
    Issuance of Recommendations for Marketing Authorization/lmport Permit 
    • The CRS issues a a recommendation to CARICOM states and the sponsor if the dossier is reviewed favourably.
    • The conditions of the recommendation include:
    • That no changes will be made to pharmaceutical aspects of the product without prior conforming to the CRS policy on variations.
    • All information must be consistent with the approved product information.
    • The CRS publishes recommended products on its website, including, but not limited to, the following information:
    • Generic name, dosage form, and strength;
    • Brand name, if applicable;
    • Registration holder;
    • Registration number;
    • Each sponsor receives a written communication from the CRS informing it of the outcome of the assessment.


    Marketing authorization in CARICOM Member States 
    • If a dossier is recommended, the CRS contacts focal points in each Member State to initiate the marketing authorization process.
    • It shares relevant dossier documentation, including assessment reports, and if requested, makes the full dossier available.
    • The intent is for this stage to be accelerated and in general Member States typically request four items: 1) completion of an administrative application form, 2) submission of the CRS assessment report and certificate of recommendation, 3) payment of user fee, and 4) identification of an importer.
    • The goal is to turn the CRS recommendation into a lawful marketing authorization in CARICOM countries within 60 calendar days.
    • The  CRS uses Memorandums of Understanding between CARPHA and the individual Member States to facilitate this process, however some countries have elected to develop fast track processes that recognize the CRS recommendations independent of the Memorandums of Understanding.

    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

    Maintenance of Recommendation Status 
    • Sponsors achieving CRS recommendation for a given product keep that status for 5 years, provided they notify the CRS of any changes or variations in manufacture and control that may have an impact on the safety, efficacy and quality of the product (see “variations” section.
    • The renewal process will be abbreviated in comparison to the first recommendation but will include showing proof of marketing of products in CARICOM markets.


    • The CRS requests that sponsors notify the CRS of variations, including provide notifications of variations to dossiers when notifying and receiving decisions from the RA on which the product’s eligibility is based.
    • Some types of changes are so significant that the sponsor must re-submit the product. These include:
    • A change of the API to a different API.
    • Inclusion or removal of an API.
    • A change in the dose of an API.
    • A change in the dosage form.
    • A change in the route of administration.
    • A change in manufacturing site.
    • Please consult with the CRS as to the appropriate action regarding a variation if there is any uncertainty about the right path.


    Suspension, Revocation, Recall, Withdrawal 
    • The sponsor must notify the CRS of any suspensions, revocations, recalls, and/or withdrawals of the sponsor’s products on the CRS registry—including in markets beyond those of the RA.
    • The CRS reserves the right to suspend or revoke a product recommendation, including, but not limited to, the following situations:
    • The quantitative or qualitative composition is not as agreed in the registration.
    • The product is found not to be in compliance with the conditions of the registration.
    • The product is a danger to public health.


    • The reviews sponsor dossiers and issues a decision within 180 calendar days (though typically within 60 calendar days) from the date of accepting the dossier for review, not including time that additional information or clarification is needed from the sponsor after accepting the dossier.
    • The The target timeline from CRS recommendation to marketing authorization in-country is 60 calendar days.
    Appeals and Complaints 
    • The CRS accepts any request for appeal or filing of a complaint, provided that the sponsor makes the request or filing in writing. 
    • The CRS addresses appeals and complaints within 30 business days in a written response.
    User Fees 
    • The CRS will charge user fees for the regulatory work it conducts in the future, which will enable a sustainable system.
    • The project is currently in the pilot phase and all user fees have been waived
    • Note that the Member States may charge their own fees in the marketing authorization phase.  It is important to keep these fees in place as they are a meaningful source of revenue for local authorities.

    CARICOM Member state engagement

    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.

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    CARPHA/CRS recommended medicines

    CARPHA/CRS recommends the medicines listed in this document to CARICOM member states for granting marketing authorization/import permit.


    VigiCarib is a voluntary regional system for CARICOM states to report medicines related adverse events (adverse drug reactions (ADRs)) and substandard and falsified (SF) 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.

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    Latest News

      Laboratory Technician 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.


      CRS Recommends Hepatitis C Cure    

      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.

      There are more NCD medicines under review at the CRS, and a goal of the program is to have recommended quality versions of all NCD medicines listed on WHO's list of essential medicines. For more information click HERE for the CRS website.


      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: or CRS at:

    Stakeholder Information

    Question: Can I submit the dossier and/or packaging/labelling in another language besides English?

    Answer: No, at this time, all dossier/packaging/labelling materials must be submitted in English.

    Question: What climate zone do I need to submit stability data for? And if this differs from the Reference Authority zone, what do I do?

    Answer: WHO’s prequalification program has guidance on this ( and the CRS follows this approach. Generally, zone IVb stability data (data generated at 302C/75 5%RH) on the primary or production batches of the product in the same packaging as approved for marketing of the finished product in the Reference Authority (RA) country, should be provided.

    If these zone IVb data are not available at the time of submission, applicants should initiate as soon as possible long-term stability testing at these conditions in the same packaging as approved by the RA. When complete, the full long term data (at minimum 12 months) should be submitted to the CRS team. Questions regarding this matter can be directed to 

    The CRS team has compiled procurement data for select priority medicines from sample Member States and procurers in the region. It can be downloaded here
    Question: What happens if my product is recommended by the CRS?

    Answer: A positive CRS review is posted on the CARPHA/CRS website, and triggers a process whereby the CRS notifies CARICOM Member States and Associate Member States, as well as regional and national procurers, of the recommendation. Pertinent dossier information, such as the assessment report compiled by the CRS, is then shared with focal points in each of these entities, and the clock begins to tick for sovereign countries to turn the recommendation into a marketing authorization. The goal is 90 calendar days.


    Trinidad and Tobago’s 2016 procurement list can be found under “New pharmaceutical pricelist booklet”.  Click here 
    The CRS team has compiled procurement data for select priority medicines from sample Member States and procurers in the region. It can be downloaded here.



    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.