https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2019/70045a-eng.php
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http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/5510392
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.
Because the CRS is voluntary, manufacturers determine the products that they submit, but medicines should be listed on the WHO Essential Medicine List or be of public health value to the region. An increasing percentage of the recommended medicines treat non-communicable diseases (about 25% currently), which make up a large disease burden in CARICOM countries. Other products that are important to public health are included, such as antibiotics and antiretrovirals. The CRS recently recommended an innovative cure and an essential medicine to treat Hepatitis C that is not currently registered anywhere in the region.
The process of review by the CRS typically takes about 6-8 weeks from receipt of documents to decision-making and recommendation to CARICOM governments. This has been found to be much faster than the current timelines in the region. This accelerated processing also enables faster access to essential quality medicines for patients.
The list of recommended products is growing by the month and can be found HERE
Como cada año, el Día Mundial del Donante de Sangre se celebrará en todo el mundo el 14 de junio. Este evento sirve para dar las gracias a los donantes voluntarios no remunerados por un regalo que permite salvar vidas, así como para concienciar de la necesidad de hacer donaciones regulares para tener acceso oportuno y asequible a sangre y productos sanguíneos seguros y de calidad, como parte integral de la salud universal y componente fundamental de los sistemas de salud eficaces.
El tema de la campaña de este año es la donación de sangre y el acceso universal a las transfusiones de sangre segura, como elemento para lograr la salud universal. Hemos adoptado el lema «Sangre segura para todos» para sensibilizar sobre la necesidad universal de sangre segura en la prestación de atención de salud y la función esencial que desempeñan las donaciones voluntarias en la consecución del objetivo de la cobertura sanitaria universal. El tema tiene por objeto alentar vivamente a más personas en todo el mundo a convertirse en donantes y a hacer donaciones regulares, acciones que constituyen la piedra angular para crear una base sólida para establecer un suministro de sangre sostenible a nivel nacional que permita atender a las necesidades de transfusión de todos las personas.
Más informaciones disponibles por el enlace https://www.paho.org/hq/index.php?option=com_content&view=article&id=15148:safe-blood-for-all-14-june-2019&Itemid=39594&lang=es
WHO published a Concept Note entitled “A FRAMEWORK FOR EVALUATING AND PUBLICLY DESIGNATING REGULATORY AUTHORITIES AS WHO-LISTED AUTHORITIES”, which will be posted on the WHO Medicines website under Current Projects for public revision and comments (https://www.who.int/medicines/areas/quality_safety/quality_assurance/qas19_808_WHO_listed_authorities.pdf?ua=1).
This Concept Note presents a proposed definition for WHO-Listed Authorities (WLAs); procedures for designating a WLA; and the process for finalizing the definition and the procedures for putting the framework into place.
Given the wide interest in and implications associated with the definition and framework, WHO will adopt a multi-prong consultation process as outlined in this Concept Note. Further details will be announced in due course.
All comments received by 17 July 2019 will be considered in the preparation of a draft policy and draft operational guidance documents. Please send any comments you may have to nra_admin@who.int , with a copy to Ms Claire Vogel (vogelc@who.int).
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