Caribbean Regulatory System 1

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).

Purpose

The CRS helps states perform key regulatory functions. The CRS does this using efficiencies, such as reliance on reference authorities and a focus on essential medicines, to enable a sustainable enterprise in the resource-constrained environment of small states. This contributes to CARPHA’s mandate to prevent diseases, promote health and respond to public health emergencies.

Legal Authority

The CRS derives its legal authority from CARPHA’s Public Health Mandate, the Caribbean Pharmaceutical Policy, and various other Ministerial health frameworks and decisions.

CARICOM’s Technical Advisory Committee on Pharmaceutical Policy (TECHPHARM), made up of representatives from CARICOM Member States and institutions, advises the CRS on policy and technical matters.

The Medicines Quality Control and Surveillance Department (MQCSD) plays an integral role, including thorough post market surveillance.

Focus Activities

Very broadly, the CRS carries out the following regulatory focus activities:

• Conducts abbreviated reviews of product dossiers for safety, quality, and efficacy of medicines and vaccines that meet the following  criteria, including:
• • the product has a current approval/registration/marketing authorization from a CRS-designated “reference authority” (e.g. PAHO regulatory authorities of reference, European Union, United States or WHO prequalification);  and
  • the product is named on the most recent version of the WHO Essential Medicine List (here) or PAHO Strategic Fund (here) - this includes innovative and generic medicines, and vaccines;"
• Recommends all favourably reviewed products to CARICOM Member States, for consideration for product approval/ registration/ marketing authorization/ import permit (see Figure 1: CRS process overview)

Benefits to Industry

The CRS benefits industry in a variety of ways. It offers a central portal for access to CARICOM’s markets of over 17 million people.

These Member States are:

Associate Member States are:

Because these countries are diverse and have different regulatory requirements and timelines for processing, the CRS benefits companies by giving them one streamlined set of requirements and a known and accelerated timeline for processing compared to what currently exists.

The requirements are based on an abbreviated and accelerated procedure WHO uses for Prequalification when a product has already been registered by a reference authority.

The CRS also participates in the WHO Collaborative Procedure, whereby sponsors that hold a prequalified product can authorize the release of corresponding assessments and inspectional information, to the CRS for review.