Welcome!

News Feed Item

Statement on international regulatory cooperation regarding Ebola

The statement below was released today by the International Coalition of Medicines Regulatory Authorities (ICMRA) interim Management Committee following a recent international meeting in Rio. In addition to Health Canada, members include the Therapeutic Goods Administration, Australia; National Health Surveillance, Brazil; China Food and Drug Administration, China; European Medicines Agency; European Commission - Directorate General for Health and Consumers; Health Product Regulatory Authority, Ireland; Italian Medicines Agency, Italy; Ministry of Health, Labour and Welfare, and the Pharmaceuticals and Medical Devices Agency, Japan; Medicines Evaluation Board, Netherlands; Health Sciences Authority, Singapore; Medicines Control Council, South Africa; Medicines and Healthcare Products Regulatory Agency, United Kingdom; Food and Drug Administration, United States.

Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks

OTTAWA, Sept. 4, 2014 /CNW/ - The largest, most severe and most complex outbreak of Ebola virus disease in history is highlighting the absence of authorised medicines to treat or prevent this terrible disease affecting people in a number of countries in West Africa.

In the face of this outbreak, medicines regulators worldwide have committed to enhanced cooperation with the World Health Organization (WHO) and between regulatory agencies to encourage submission of regulatory dossiers and evaluation of the submitted information on potential new medicines. The aim is to accelerate access to investigational treatments for patients most in need during the current outbreak.  The enhanced cooperation also aims to ensure that in the future, public health authorities in countries affected by Ebola have safe and efficacious medicines at their disposal, and so strengthen their ability to respond effectively to outbreaks and to save lives.

This pledge was made by members of an interim International Coalition of Medicines Regulatory Authorities (ICMRA) in the margins of the 16th WHO International Conference of Drug Regulatory Authorities (ICDRA) held in Rio de Janeiro from 24-29 August 2014.

Over the past decade, research has been carried out into medicines and vaccines to protect against or to combat Ebola.  Some of the investigational medicines or vaccines studied have shown encouraging results in the laboratory and in animal models.  However, they have not yet been evaluated for safety and efficacy in humans for the treatment or prevention of Ebola virus disease and may pose risks that have not yet been identified.  In addition, these products may be ineffective and it is even possible that some of these investigational medicines might worsen the ultimate outcome of Ebola virus disease.

The role of medicines regulators is to evaluate the detailed evidence generated in clinical studies and to determine that the benefit risk balance of using those medicines is positive for patients in need of prevention or treatment of disease.  The countries most affected by the current outbreak of Ebola virus disease often do not have reliable systems for routine data collection. In the current crisis, it is a great challenge to come up with practical solutions to ensure that meaningful data is collected and assessed so that decisions on the benefits and risks of medicines can be taken on the basis of limited scientific evidence, avoiding undue risks to patients.

Regulatory agencies therefore have pledged at their Rio de Janeiro meeting to join their expertise to consider evidence from a wide range of sources to allow for decision-making under a greater degree of scientific uncertainty. 

Although the development of medicines against Ebola is ongoing, the majority of patients affected by the virus do not have access to these treatments.  Regulators therefore also stress that the search for pharmaceutical interventions must not detract from the need to strengthen basic healthcare measures such as fluids and electrolytes management and to carefully observe the impact and contribution of these measures in the overall response to the disease.

It is important to note that the most effective way to combat the current Ebola outbreak is through basic public health measures, such as good infection control, isolation, contact tracing, and use of personal protective equipment.

These issues will be discussed at a WHO CONSULTATION on potential Ebola therapies and vaccines on 4-5 September in Geneva with regulatory experts from leading agencies worldwide expected to play a key role.

Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media

SOURCE Health Canada

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"I think that everyone recognizes that for IoT to really realize its full potential and value that it is about creating ecosystems and marketplaces and that no single vendor is able to support what is required," explained Esmeralda Swartz, VP, Marketing Enterprise and Cloud at Ericsson, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Microservices are a very exciting architectural approach that many organizations are looking to as a way to accelerate innovation. Microservices promise to allow teams to move away from monolithic "ball of mud" systems, but the reality is that, in the vast majority of organizations, different projects and technologies will continue to be developed at different speeds. How to handle the dependencies between these disparate systems with different iteration cycles? Consider the "canoncial problem" ...
As businesses adopt functionalities in cloud computing, it’s imperative that IT operations consistently ensure cloud systems work correctly – all of the time, and to their best capabilities. In his session at @BigDataExpo, Bernd Harzog, CEO and founder of OpsDataStore, will present an industry answer to the common question, “Are you running IT operations as efficiently and as cost effectively as you need to?” He will expound on the industry issues he frequently came up against as an analyst, and...
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
After more than five years of DevOps, definitions are evolving, boundaries are expanding, ‘unicorns’ are no longer rare, enterprises are on board, and pundits are moving on. Can we now look at an evolution of DevOps? Should we? Is the foundation of DevOps ‘done’, or is there still too much left to do? What is mature, and what is still missing? What does the next 5 years of DevOps look like? In this Power Panel at DevOps Summit, moderated by DevOps Summit Conference Chair Andi Mann, panelists l...
In their Live Hack” presentation at 17th Cloud Expo, Stephen Coty and Paul Fletcher, Chief Security Evangelists at Alert Logic, provided the audience with a chance to see a live demonstration of the common tools cyber attackers use to attack cloud and traditional IT systems. This “Live Hack” used open source attack tools that are free and available for download by anybody. Attendees learned where to find and how to operate these tools for the purpose of testing their own IT infrastructure. The...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
Virtualization over the past years has become a key strategy for IT to acquire multi-tenancy, increase utilization, develop elasticity and improve security. And virtual machines (VMs) are quickly becoming a main vehicle for developing and deploying applications. The introduction of containers seems to be bringing another and perhaps overlapped solution for achieving the same above-mentioned benefits. Are a container and a virtual machine fundamentally the same or different? And how? Is one techn...
SYS-CON Events announced today that MobiDev, a client-oriented software development company, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex softw...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...
Whether you like it or not, DevOps is on track for a remarkable alliance with security. The SEC didn’t approve the merger. And your boss hasn’t heard anything about it. Yet, this unruly triumvirate will soon dominate and deliver DevSecOps faster, cheaper, better, and on an unprecedented scale. In his session at DevOps Summit, Frank Bunger, VP of Customer Success at ScriptRock, discussed how this cathartic moment will propel the DevOps movement from such stuff as dreams are made on to a practic...