The Caribbean Regulatory System (CRS) is pleased to announce its first ever expression of interest (EOI) for sponsors to submit dossiers to the CRS for medicines on its priority medicines list. The CRS is a regional regulatory system being implemented by the Caribbean Community’s (CARICOM) regional public health agency, the Caribbean Public Health Agency (CARPHA), in collaboration with the Pan American Health Organization/ World Health Organization (PAHO/WHO).
The CRS is a response to the unique circumstances of small island states, and is focused on registering generic (multisource) medicines via an abbreviated dossier review process that uses reliance on reference authorities to efficiently and effectively complete its work. If reviewed favorably, the product is said to be “registered” and the CRS recommends it to all CARICOM Member States for marketing authorization.
The benefits of seeking registration with the CRS are numerous, including the following: harmonized requirements through a centralized portal to CARICOM markets of over 17 million people; rapid uptake of CRS recommendations to marketing authorizations in participating Member States; access to procurement markets at the national and regional levels; and publication of favorably reviewed products on CARPHA’s website for CARICOM Member States and procurers to see.
Dossier submission requirements conform to strict international standards and are compatible with the International Conference on Harmonization Common Technical Document.
Interested sponsors should send submission inquiries to CRSRegistration@CARPHA.org