Safe, High Quality Drugs Assured With Caribbean Regulatory System

The establishment of a Caribbean Regulatory System (CRS) will improve conditions for patients in the region to receive safe, efficacious, high quality drugs.

Executive Director of the Caribbean Public Health Agency (CARPHA) Dr. James Hospedales gave that assurance as he promised that access to safe, efficacious and good quality drugs is a human right which the regional public health organization is committed to facilitating.

CARPHA, in collaboration with CARICOM and World Health Organisation/Pan American Health Organisation (WHO/PAHO), has established a CRS.

Dr. Hospedales explained that the CRS will focus on providing regulatory assurance to essential generic medicines for the region.
“Through the CRS, CARPHA will be able to help countries perform functions such as reviewing, approving and monitoring medicines, in a timely manner, allowing patients faster access to quality drugs,” he said, adding that it would also help to reduce cost of medicines to consumers and the health system, thus improving accessibility and affordability.

With only five CARICOM countries currently conducting a review of safety, quality, and efficacy of drugs, PAHO Country Representative for Trinidad and Tobago, Dr. Bernadette Theodore-Gandi, emphasized the need for strong regulatory systems for medicines.

She pointed out that limited capacity in the regulation of medicines can have several negative results, including the proliferation of substandard and falsified medicines.

The best international practices recommend transparency and accountability in regulatory operations, including reasonable timelines for granting marketing authorization, clear systems for stakeholders and for regulators to prevent products which do not satisfy established standards from being offered for use to people.

The CRS is not intended to replace already established national regulatory authorities, but to augment and support them. It will also coordinate reporting and analysis on medicine safety and quality issues within CARICOM.

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