Washington D.C., 13 December 2019 (PAHO)— The Pan American Health Organization (PAHO) will continue supporting the Caribbean Regulatory System (CRS) through technical cooperation to expand and optimize the mechanism with the extension of a 3-year grant awarded by the Bill and Melinda Gates Foundation.
The CRS is a centralized regulatory mechanism intended to improve timely access to quality affordable essential medicines in the Member and Associate States of the Caribbean Community (CARICOM), and monitor medicines in the market. The mechanism is managed by the Caribbean Public Health Agency (CARPHA).
The project will build on the CRS successes and address some of the challenges. Over the last 3.5 years, the CRS has solidified its presence in the region, recommending nearly 70 essential medicines for market authorization, including for priority areas such as non-communicable diseases. It has also strengthened surveillance of adverse events and substandard and falsified medicines through the VigiCarib reporting system, which has resulted in over 200 reports submitted to WHO databases, and a global product alert for falsified products found in Haiti. It solidified its management structure with the hiring of a senior technical coordinator at CARPHA last year, and recently received its first user fees paid by companies that are interested in using the system. It is also working more closely with the CARPHA medicines testing lab.
During the first year of the next phase, the CRS will expand eligibility criteria from medicines and vaccines to other essential biologics, while continuing to use the same reliance verification methodology. PAHO is working to support a regional workshop that will bring CARICOM states together to understand best practices and principles in regulation of biosimilars.
In the second year, the initiative will contemplate the development of a proposal to help Member States without regulatory authorities review quality documentation (e.g. in procurement programs) as well as to design a system whereby the CRS can evaluate products that are not approved in reference authorities through regional inspection teams.
The CRS will also work to solidify interaction and learning with other regionalization initiatives in Africa and the Pacific Islands, as well as explore options for pooling markets such as with the new regulatory mechanism established in Central American states that PAHO is also supporting.
“We are thrilled that the Gates Foundation is continuing to support this important work. Small states with small populations and markets face a unique set of challenges that limit their regulatory capacity. By adding efficiencies, such as relying on reference authorities for marketing authorization, sharing information, digitizing systems, and working together, small states can do more with less” said Charles Preston, Advisor on Regulatory System Strengthening for Medicines and Other Health Technologies at PAHO. “Many regulatory systems take decades to build, but these CARPHA programs are making critical gains towards sustainably addressing a major public health challenge and can be a model for other small states,” he added.