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FDA & European Medicines Agency collaborate on drug quality and manufacturing data to improve patient access to medically necessary medications

The FDA and the European Medicines Agency (EMA) are publishing the discussion and main conclusions from a workshop held on November 26, 2018, at the EMA headquarters in London, supporting quality development for the FDA’s Breakthrough Therapy Designation and EMA’s Priority Medicines (PRIME) programs for patients with unmet medical needs. The workshop between regulators and industry discussed quality challenges and scientific and regulatory approaches for facilitating development and preparation of robust quality data packages, to enable timely access to medicines for patients while keeping in mind the importance of drug safety and quality and maintaining current standards of approval.

For more information go to https://www.fda.gov/news-events/fda-brief/fda-brief-fda-european-medicines-agency-collaborate-drug-quality-and-manufacturing-data-improve 

 
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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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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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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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Chile: Presencia de partículas Cloxinato de Lisina Solución inyectable 100 mg/2 ml

Alerta Farmacéutica 2/19 – Retiro del Mercado

Clonixinato de Lisina Solución Inyectable 100mg/2 mL. (analgésico, antiinflamatorio no esteroidal (Aines)

Serie 75MH1541 – 75ML2081.

Fecha de vencimiento: 08/2021 – 11/2021

Fabricante: Laboratorio Sanderson S.A/Chile

Descripción del defecto: Presencia de partículas, cuyo origen se encuentra en estudio.

más informaciones por el enlace http://www.ispch.cl/sites/default/files/comunicado/2019/02/19-02-2019%20-%20Presencia%20de%20partículas%20clonixinato%20de%20lisina…..pdf

 
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Mexico advances in consolidated procurement of vaccines and medicines

They set up an analysis to discuss Mexico’s participation in the Revolving and Strategic Funds of PAHO / WHO.

As an active member of the PAHO / WHO Pan-American and World Health Organizations, Mexico seeks the direct purchase of certain vaccines and medicines through Revolving and Strategic Funds from these international organizations, from which it would obtain benefits with respect to the prices offered.

For more information go to https://www.gob.mx/cofepris/articulos/mexico-avanza-en-compra-consolidada-de-vacunas-y-medicamentos-186105?idiom=es 

 
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Statement from the Minister of Health on the Regulation of Medical Devices in Canada

Statement

November 29, 2018 – Ottawa, ON – Health Canada

As Minister of Health, protecting the health and safety of Canadians is my top priority. I am deeply concerned by recent reports of serious issues Canadians have been facing with implanted medical devices.

Canada has one of the best regulatory systems in the world for medical devices. Canadians can be confident that the medical devices available in this country have met high standards for safety and efficacy. Health Canada has been taking steps to strengthen its regulation of medical devices, and I have asked that this work be accelerated.

Beyond these existing efforts, however, the Government of Canada agrees that more can be done to further strengthen the oversight of medical devices and to be more open and transparent with Canadians about Health Canada’s regulatory activities. I have directed Health Canada to bring forward an Action Plan to accelerate these efforts on a priority basis and to work with partners on behalf of Canadians.

I have asked the Department to enhance its activities in three key areas:

1. To strengthen processes for the pre-market approvals of medical devices: This will include a review of the policies and scientific requirements for the approval of higher-risk medical devices, including requirements for clinical data. I have also directed Health Canada to take action to enable more medical device research by health professionals, and expand the use of outside medical and scientific experts to advise the Department on medical device issues.

2. To enhance post-market surveillance of medical devices: Working with partners, Health Canada will take steps to improve the reporting of medical device incidents by industry, health professionals and Canadians and make these reports publicly available. The Department will propose new rules requiring that companies inform Health Canada promptly when key foreign regulators issue warnings about a device, so that we can inform Canadians more quickly. The Department will also strengthen its compliance and enforcement activities by modernizing its existing tools and increase its inspection capacity to better identify problems before they affect Canadians.

3. To make the system for medical device approvals and surveillance more transparent: Health Canada will take steps to give Canadians additional information so that they can make better informed decisions about their use of medical devices. The Department will provide summaries of regulatory decisions when it approves more complex medical devices (known as Class III and Class IV devices). Health Canada will also work to improve access to the clinical data that support our authorizations, so that health professionals can better evaluate the benefits and risks of devices for their patients.

The full details of Health Canada’s Action Plan for Medical Devices will be published in the coming weeks.

The world of medical devices is constantly evolving, and the Government of Canada is working to ensure that our regulations and guidance keep pace so that Canadians can have confidence in the medical devices that they need.

The Honourable Ginette Petitpas Taylor, P.C., M.P.

Contacts

Thierry Bélair
Office of Ginette Petitpas Taylor
Minister of Health
613-957-0200

Media Relations
Health Canada
613-957-2983
hc.media.sc@canada.ca

Source: https://www.canada.ca/en/health-canada/news/2018/11/statement-from-the-minister-of-health-on-the-regulation-of-medical-devices-in-canada.html

 
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Cofepris: Consolidated route, regulate better and prohibit less

The Federal Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz, assured that since there is a very clear link between health and development in the countries, it should be “better regulated and less prohibited”, for the benefit of the health of the people; “Strong and healthy populations make countries stronger,” he said.

For more information go to https://www.gob.mx/cofepris/articulos/ruta-consolidada-regular-mejor-y-prohibir-menos-jsyt-183268?idiom=es 

 
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PAHO Job opportunity: Advisor, Noncommunicable Diseases Management

Advisor, Noncommunicable Diseases Management

Grade: P4

Contractual Arrangement: Fixed-Term Appointment

Contract duration: Two years, first year probationary period

Primary Location: United States-Washington, D.C.

Organization: PAHO Department on Noncommunicable Diseases and Mental Health

Schedule: Full-time

 

Application Closing Date: Dec 10, 2018, 5:59:00 PM

 

Job description and application process available online:  https://careers.who.int/careersection/ex/jobdetail.ftl?job=1805658&lang=en