Caribbean Regulators adopt Framework to Strengthen Regulatory Systems

09 Nov, 2018 11:05
San Salvador, El Salvador.  Senior government pharmacists and regulators from Antigua and Barbuda, Bahamas, Barbados, Belize, British Virgin Islands, Guyana, Haiti, Jamaica, Saint Lucia, St. Vincent and the Grenadines, Suriname, and Trinidad and Tobago, participated in the biannual Pan American Network of Drug Regulatory Harmonization (PANDRH) . The Caribbean Public Health Agency (CARPHA), the Agency managing the Caribbean Regulatory Systems (CRS) on behalf of the Dutch and English-speaking Caribbean, was represented at the meeting by Dr Asin-Oostburg, Director of Surveillance, Disease Prevention and Control.

The network is dedicated to promoting regulatory harmonization and convergence around standards and processes so that medicines regulation can be similar across jurisdictions and done according to the best international practices.  During the 3-day meeting, delegates moderated and presented on a range of topics important to the Region, including: how to improve registration and post market surveillance systems, over-the-counter medicines regulation, supply chain control, and advancements in the CARPHA CRS, to name a few.  In her presentation, Dr Asin-Oostburg pointed out that the future vision for the CARPHA CRS is increased access, reduced cost, easy for industry, through a shared approach to regulatory capacity building, appropriate to Caribbean Single Market Economy (CSME). 

When the Conference meets, delegates also work to adopt common recommendations to the PANDRH community, which in addition to regulators, includes industry. At this Conference, decisions were taken to adopt principles for reliance; frameworks to strengthen regulatory systems in small states, including use of the CARPHA/CRS; and a cautious approach to regulation of cell and tissue therapies. 

This work comes at an important time. PAHO, the secretariat of the Conference, stated that although 60% of states in the Americas have regulatory authorities of reference or comprehensive regulatory systems, about 40% have some or no legal or organizational frameworks to conduct medicines regulation.  On a population level, about 98% of the Americas are covered with comprehensive systems, while 2% are not. Although this may seem like a small number, there are 1 billion people in the Americas, and 2% amounts to roughly 18 million people, many of whom reside in CARICOM countries.  

In opening remarks to the Conference, Dr Jarbas Barbosa, Assistant Director of PAHO/WHO, said that regulatory systems are an integral part of strong health systems because they assure that medicines are safe, quality, and effective. There cannot be achievement of Universal Health, or the Sustainable Development Goals, without them. 

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