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
Cloud applications are seeing a deluge of requests to support the exploding advanced analytics market. “Open analytics” is the emerging strategy to deliver that data through an open data access layer, in the cloud, to be directly consumed by external analytics tools and popular programming languages. An increasing number of data engineers and data scientists use a variety of platforms and advanced analytics languages such as SAS, R, Python and Java, as well as frameworks such as Hadoop and Spark...
Interested in leveling up on your Cloud Foundry skills? Join IBM for Cloud Foundry Days on June 7 at Cloud Expo New York at the Javits Center in New York City. Cloud Foundry Days is a free half day educational conference and networking event. Come find out why Cloud Foundry is the industry's fastest-growing and most adopted cloud application platform.
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing bes...
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Regardless of what business you’re in, it’s increasingly a software-driven business. Consumers’ rising expectations for connected digital and physical experiences are driving what some are calling the "Customer Experience Challenge.” In his session at @DevOpsSummit at 20th Cloud Expo, Marco Morales, Director of Global Solutions at CollabNet, will discuss how organizations are increasingly adopting a discipline of Value Stream Mapping to ensure that the software they are producing is poised to o...
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. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
Most DevOps journeys involve several phases of maturity. Research shows that the inflection point where organizations begin to see maximum value is when they implement tight integration deploying their code to their infrastructure. Success at this level is the last barrier to at-will deployment. Storage, for instance, is more capable than where we read and write data. In his session at @DevOpsSummit at 20th Cloud Expo, Josh Atwell, a Developer Advocate for NetApp, will discuss the role and value...
SYS-CON Events announced today that Outscale, a global pure play Infrastructure as a Service provider and strategic partner of Dassault Systèmes, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2010, Outscale simplifies infrastructure complexities and boosts the business agility of its customers. Outscale delivers a secure, reliable and industrial strength solution for its customers, which in...
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
IBM helps FinTechs and financial services companies build and monetize cognitive-enabled financial services apps quickly and at scale. Hosted on IBM Bluemix, IBM’s platform builds in customer insights, regulatory compliance analytics and security to help reduce development time and testing. In his session at 20th Cloud Expo, Tom Eck, Industry Platforms CTO at IBM Cloud, will discuss how these tools simplify the time-consuming tasks of selection, mapping and data integration, allowing developers ...
In order to meet the rapidly changing demands of today’s customers, companies are continually forced to redefine their business strategies in order to meet these needs, stay relevant and continue to see profitable growth. IoT deployment and development is integral in this transformation, and today businesses are increasingly seeing the value of investing their resources into IoT deployments. These technologies are able increase ROI through projects such as connecting supply chains or enabling sm...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus intern...
Everywhere we turn in our industry we can find strong opinions about the direction, type and nature of cloud’s impact on computing and business. Another word that is used in every context in our industry is “hybrid.” In his session at 20th Cloud Expo, Alvaro Gonzalez, Director of Technical, Partner and Field Marketing at Peak 10, will use a combination of a few conceptual props and some research recently commissioned by Peak 10 to offer a real-world consideration of how the various categories of...