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Belize: Ministry of Health Confirms Quality Generic Medications

Belmopan. July 16, 2019.  As part of its ongoing initiatives to provide quality healthcare medications, the Ministry of Health sent five different generic medications to the Caribbean Regional Public Health Agency’s (CARPHA) Drug Testing Laboratory, which is CARICOM’s regional reference laboratory for testing. The medications range from antibiotics to antidiabetic drugs that were sampled from the public sector.

All five medications have passed the quality tests performed as per international standards. This means that these generic medications are of confirmed quality.

The medications tested were:

Product Name Manufacturer Batch No. Expiry Date
Ciprofloxacin 500 mg tablets GAMMA Laboratorios, El Salvador C17100 03/2020
Glibenclamide 5 mg tablets Generifar S.A., Nicaragua 271418 04/2021
Atenolol 50 mg tablets Generifar S.A., Nicaragua 761418 04/2021
ACEVIRAL (Aciclovir) 400 mg caplet Gefarca Industria Farmaceutica, Dominican Republic 197/17 07/2020
Amoxicillin 500 mg tablets Reyoung Pharmaceutical Co. Ltd., China 163132189 9/2019

The medications were selected based on a risk-based approach strategy which includes medications from the larger population and public health program. The Ministry remains committed in the continuous monitoring of pharmaceuticals and hereby seeks ongoing public engagement in reporting any suspicious medication to the Drug Inspectorate Unit at 828-4467 or via the drugalert@health.gov.bz email.

Ends

For more information, contact:

Mrs. Danini Marin

Director – Drug Inspectorate Unit, Ministry of Health

828-4466

 
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Belize became the first country in the CARICOM block of countries to publish a list of registered medicines

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

 
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40th Medicine Recommended to CARICOM Governments

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

 

 
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Safe blood for all. 14 June 2019

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

 
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WHO PUBLIC CONSULTATION: Working document QAS/19.808 – Concept Note: A Framework for Evaluating and Publicly Designating Regulatory Authorities as WHO-Listed Authorities: Request for comments by 17 July 2019

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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Lancet publishes editorial about Universal Health Care in 21st century Americas

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

 
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Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada

March 19, 2019
Our file number: 19-101967-390

Under the Regulatory Review of Drugs and Devices initiative, Health Canada is increasing the efficiency of the regulatory system and supporting timely access to therapeutic products. As part of this initiative, Health Canada is pleased to announce the launch of the e-Learning tool, Understanding How Medical Devices are Regulated in Canada – Premarket Regulation.

This web-based tool, designed as an interactive learning platform, offers an overview of Health Canada’s premarket regulatory requirements for medical devices. It also provides targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

The tool serves as a valuable, comprehensive, and organized source of premarket regulatory information for various medical device stakeholder groups, including manufacturers, importers, distributors, consultants, healthcare groups, and academia. By providing e-Learning content to  manufacturers and other relevant stakeholders, it is expected that the completeness and quality of Medical Device Licence applications will improve, thereby resulting in more positive, and more timely, regulatory decisions.

Health Canada encourages and invites stakeholders to utilize and benefit from this new educational tool.

Questions or concerns regarding this notice or the e-Learning tool should be directed to the Medical Devices Bureau at hc.mdb.enquiries-enquetes.bmm.sc@canada.ca.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-e-learning.html

 
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29 March- Webinar RedETSA in Spanish – Modelo Web de Análisis de Impacto Presupuestario

We would like to share with you the invitation received in its original language (Spanish) to participate in the Health Technology Assessment Network of the Americas (Red de Evaluación de Tecnologías en Salud de las Américas – RedETSA) webinar program on 29 March, 11am (EST) where Alfredo Palacios, Instituto de Efectividad Clínica y Sanitaria (IECS) will discuss the “Web model of budget impact analysis”.

The link that will be used to access this Webinar is available as follows: https://goo.gl/Rxrxki

 
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Caribbean Regulatory System Recommends Hepatitis C Cure    

Recently, the CARPHA/CRS recommended Gilead’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg) film-coated tablet for the treatment of Hepatitis C.

The product is the first combination of its kind, and is listed on the WHO Essential Medicine List. It is also a first line therapy as recommended by WHO. The rationale for such an important status is that Epclusa is curative for all genotypes of Hepatitis C. If not treated, Hepatitis C can lead to negative health outcomes like liver failure and cancer.

This is a significant development for patients in CARICOM because there are estimated to be perhaps 100,000 cases of Hepatitis C in the region, but few authorized treatments. Epclusa, for example, does not have marketing authorization in any CARICOM state. It is also significant for public health. Cures such as this one are critical to strategies to eliminate Hepatitis C in the Americas.

Patients need access to these innovative therapies quickly, and major manufacturers are increasingly using the CRS because of the efficiencies it brings in speeding access to medicines. The CARPHA/CRS pools CARICOM markets together and offers a single portal of entry to the region’s 17 million people with one set of internationally recognized standards, and accelerated and transparent timelines. It is a major improvement over the current status quo in regulation of medicines, where products can take years to receive approval in the different national systems of CARICOM.

The list of recommended products is growing by the month and can be found here.

 For more information go to http://carpha.org/what-we-do/laboratory-services-and-networks/crs