GO

About the Caribbean Regulatory System

 

The Caribbean Regulatory System (CRS) is an initiative of the Caribbean Community and Common Market (CARICOM) and is managed as a regulatory unit within CARICOM’s regional public health body, the Caribbean Public Health Agency (CARPHA). It is supported by a number of partners, including the Pan American Health Organization/World Health Organization (PAHO/WHO), PAHO designated National Regulatory Authorities of Regional Reference (NRA/RR) (Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, United States), and the Bill and Melinda Gates Foundation (BMGF).


Our Origins

In 2016 CARICOM Ministers of Health agreed to the creation of the Caribbean Regulatory System (CRS) under CARPHA to support Member States to perform two key regulatory functions: marketing authorization and pharmacovigilance of medicines and vaccines.

 

Our Vision

Supporting access to safe, quality-assured, affordable medical products for the Caribbean, and their rational use. 

 

Our Mission

Through dedication to efficiency, transparency, resource-sharing, and capacity-building, we provide recommendations for market authorization, rational use, and quality and safety monitoring of medical products in the Caribbean.

 

Benefits to State

CRS can help CARPHA / CARICOM Member States to: 

  • Reduce the amount of resources needed to review medicines for market registration and/or import approval.
  • Identify safety and quality issues that may need monitoring and action.
  • Realign staff functions to increase efficiencies and/or expand scope of work.

 

Benefits to Industry

Through the CRS, market authorization holders can:

  • Apply for market entry among CARPHA Member State markets of over 17 million people.
  • Use a streamlined process for review, particularly for countries without a formal process.
  • Experience faster market access, particularly for WHO Prequalified medicines and vaccines.
  • Submit case reports of suspected adverse reactions and quality issues for countries without reporting systems.

 

How we do it?

The CRS supports CARPHA Member States’ marketing authorization functions by:

(i) reviewing and recommending medicines and vaccines, using regulatory reliance, and

(ii) by maintaining a network for regional pharmacovigilance (VigiCarib), to report medicines related adverse events and substandard and falsified products to Member States and global monitoring systems.  

 

 
For more information or submission of queries