This announcement serves as an official notice that the CARPHA Caribbean Regulatory System (CRS) will be implementing User Fees effective November 15, 2019.The CRS became operational in 2017 and has received over 100 specific medicine applications for recommendation to CARICOM Member States. Since its inception, the CRS has issued recommendations for a number of essential medicines. This list is publicly available and may be found on the CRS’ webpage.
Most regulatory authorities charge fees to pharmaceutical companies for the review of medicines for safety, quality, and efficacy. This helps ensure that the regulatory authority is equipped with adequate infrastructure, including staff and administrative tools, to process applications in a timely and transparent way, and to implement monitoring systems.
The range of user fees charged by regulatory authorities worldwide is broad, and this affects the efficiency of the authorities. For example, hundreds of thousands of dollars are charged for generic medicines in some markets, and for innovator products the fees may be in the millions. CARICOM states charge anywhere from $50 United States Dollars (USD) to $150USD. This limits the capacity, efficiency and growth of Caribbean regulatory authorities.
Although the CRS is voluntary, it enables applicants to use a single portal and uniform standards for accelerated access to the wider CARICOM market of approximately 17 million people through marketing authorization and procurement opportunities. Please check with the CRS on particular countries of interest.
The user fee is outlined below:
Note: The entity that is submitting the application to the CRS (known as the “applicant” (either importer or manufacturer)) is responsible for paying the application fee. This fee is due before the product can be considered, and will be subject to a renewal fee at the time of expiry of the recommendation. Applicants must provide all requested documentation within one year of initial submission, or re-apply by paying the application fee again.
The application fee is independent of the CRS recommendation decision. The lower fee for local importers is designed to encourage manufacturers to submit products through importers when possible, given that in many CARICOM countries, a local importer is a requirement for marketing authorization. Manufacturers/importers will still be responsible for paying all user fees at the local level, independent of the CRS user fees.
The CRS user fees may be reviewed and updated periodically based on the demand for reviews and the resource requirements. Fees may be paid electronically, using the following instructions: