It was published the document “Regulatory reliance principles: concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH) (San Salvador, 24 to 26 October, 2018)”.

The aim of this document is to outline key examples and principles for the practice of regulatory reliance. Its rationale is multifold: (a) it follows on previous discussions at the 2016 Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH), and (b) it fulfills a recommendation by the Conference that requested PAHO to develop a concept paper on reliance for PANDRH stakeholders to consider for endorsement. This concept paper builds on a presentation that was made at the 2016 Conference and integrates global thinking on the subject, including a recent document by the World Health Organization (WHO). The overarching goal is to ensure that PANDRH stakeholders continue to build understanding around reliance in ways that can better inform scenarios for its use.

The concept note is available here

CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.

For more information go to https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education

Belize began registering medicines as a result of the Food and Drugs (Registration, Licensing and Inspection) Regulations passed in 2017,  and the products that are listed are new to the country. Previously imported medicines that were available in the market prior to the new regulations were grandfathered into the system while ensuring its safety, efficacy and quality. The publication of a list of registered medicines is a best practice in transparency and accountability of regulatory systems as recommended by PAHO/WHO. Among the many benefits, it helps to provide the public and other stakeholders with visibility over what is legally approved to be sold in the market. Other countries in the CARICOM block can look to Belize as an important leader in this area.

For more information go to: http://health.gov.bz/www/units/drug-inspectorate-unit/drug-registration/989-new-drugs-registered-2017-2019

CARPHA’s Caribbean Regulatory System (CRS) recently recommended its 40th medicine to CARICOM governments. “This is an important milestone for the CRS because it shows that manufacturers are increasingly using the system and it can work” said Dr. Virginia Asin, who oversees the program as the Director, Surveillance, Disease Prevention and Control at CARPHA. The updated list of recommended medicines is publicly available on CARPHA’s webpage. 

The CRS assists the small states of CARICOM with the resource- and time-intensive task of evaluating medicines for safety, quality, and efficacy. Its approach requires that all medicines reviewed are already approved by a PAHO-designated reference authority, the European Union, or WHO Prequalification program. Once confirmed as eligible, the medicines intended for the CARICOM markets are verified as the same. Internal data show that the medicines available in highly regulated markets are not necessarily the same products that are sold in CARICOM.

This year, World Blood Donor Day will once again be celebrated around the world on 14 June. The event serves to thank voluntary, unpaid blood donors for their life-saving gifts of blood and also to raise awareness of the need for regular blood donations to ensure that all individuals and communities have access to affordable and timely supplies of safe and quality-assured blood and blood products, as an integral part of universal health coverage and a key component of effective health systems.

Focus of this year’s campaign

The theme of this year’s campaign is blood donation and universal access to safe blood transfusion, as a component of achieving universal health coverage. We have developed the slogan “Safe blood for all” to raise awareness of the universal need for safe blood in the delivery of health care and the crucial roles that voluntary donations play in achieving the goal of universal health.

Host for World Blood Donor Day 2019

• The host country for World Blood Donor Day 2019 is Rwanda. The global event will be held in Kigali, Rwanda on 14 June 2019.
• The host for the Region of the Americas event will be Costar Rica.

For more information go to https://www.paho.org/hq/index.php?option=com_content&view=article&id=15148:safe-blood-for-all-14-june-2019&Itemid=39594&lang=en

Despite considerable progress, the Pan American Health Organization (PAHO) estimates that 30% of the population of the Americas still do not have access to the health care they need because of multifaceted barriers. On April 9, leaders, including Mexico’s President Andrés Manuel López Obrador, PAHO director Carissa Etienne, and UN High Commissioner for Human Rights Michelle Bachelet, gathered with academics, activists, and representatives of social movements in Mexico City to hear the report of the Commission on Universal Health in the 21st Century (…) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30864-5/fulltext