The Caribbean Regulatory System (CRS) managed by the Caribbean Public Health Agency (CARPHA) is pleased to announce its first reviews and recommendations for marketing authorization or import permit of two essential medicines. This is an historic achievement because it is the first time CARPHA has performed this critical public health function to support the region.
The recommendations are based on a thorough assessment of the safety, quality and effectiveness of these products. The CRS collaborated with the World Health Organization (WHO)’s program to facilitate marketing authorization of prequalified medicines, called the “Collaborative Procedure”, and completed its assessment within the 90-day timeline.
The CRS’s recommendations can be seen as a first step towards strengthening medicines regulation in the CARICOM region. Small states face particular challenges related to regulation because strong regulatory systems require financial resources and technical expertise. For example, there are major backlogs of products for marketing authorization in some countries that can affect patients’ access to medicines. The CRS addresses this by pooling resources and leveraging collective platforms to create a regional approach that will augment and support existing individual state capacity, and do so with strong accountability and performance metrics in mind, such as rapid timelines for decisions.
The CARPHA/CRS will continue to make further recommendations that will populate an official list of medicines that governments and procurers can reference in their marketing authorization and procurement decisions. Governments are requested to act on the CARPHA/CRS recommendations within 60 calendar days to speed access to these products for patients.
For more information, please visit the CARPHA/CRS webpage.