• medicine

Caribbean Public Health Agency/Caribbean Regulatory System and PAHO Agree to Share Non-Public Information Related to Medicines and Biologics

14 Jan 2021

Bridgetown, 14 January 2020 (PAHO/WHO)—In December 2020, the Caribbean Public Health Agency (CARPHA)/the Caribbean Regulatory System (CRS) signed an agreement with PAHO/WHO to share information, including non-public information, on products that have been recommended by PAHO for procurement processes through the PAHO Strategic Fund (SF).  It is expected that this will improve access to quality assured medicines and biologics, enhance post-market surveillance, and support regulatory system strengthening in CARPHA’s Member States, which are also PAHO Member States.  

The PAHO Strategic Fund is a regional technical cooperation mechanism for pooled procurement of essential medicines and strategic health supplies and is a central component of PAHO's strategy to move towards Universal Health. The CRS is a voluntary regional regulatory mechanism for medicines that serves CARICOM and CARPHA Member States. It is housed in and managed by CARPHA with technical support provided by PAHO. The CARPHA/CRS reviews medicines for recommendation to CARPHA Member States for marketing authorization/registration using the same criteria as PAHO (e.g. WHO prequalified products and products that hold a marketing authorization granted by a PAHO recognized regulatory authority).

When a supplier submits a dossier to CARPHA/CRS, it performs a verification procedure to ensure that the product being offered is the same as what was approved by either WHO prequalification team or the reference authority. Thanks to this agreement, PAHO will support the CRS’s review process by being able to share the technical proposals of recommended products for procurement through the PAHO SF, including but not limited to, documentation related to proof of compliance with eligibility criteria of the technical proposals.  At the same time, PAHO Member States that use the SF will benefit from this agreement as CARPHA/CRS will notify of any quality issues related to these products. 

PAHO and CARPHA/CRS will share this information through a secure electronic platform known as REPS-RISE. This platform was developed by PAHO with the support of recognized regulatory authorities (e.g. FDA, ANVISA, Health Canada, TGA, and MLHW) to facilitate the exchange of non-public information by providing regional and international stakeholders with access to a secure environment for the exchange of documents on regulatory processes and decisions related to all health technologies.