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Health products international activities

Health Canada is collaborating with our international partners on issues related to drug and medical device clinical trials, authorizations, risk assessments, and potential shortages. Learn about how we are

engaging our international partners on COVID-19 health products issues

.

Health Canada has a long history of cooperation with international counterparts and organizations. Our engagement takes many forms ranging from informal information exchanges to multilateral harmonization initiatives.

We engage internationally to:

leverage resources and knowledge

ensure the application of sound regulatory practices and standards which are consistent, whenever possible, with international norms

strengthen and facilitate existing mutual cooperation with international jurisdictions in scientific and regulatory areas

address the challenges of globalization, new technologies and timely approval of new medicines

reduce risks associated with therapeutic products marketed in Canada

Strong relations and dialogue with international counterparts are important in achieving program objectives in an increasingly complex regulatory world.

On this page

Access Consortium

Bilateral Partnerships

Canada-United States Regulatory Cooperation Council (RCC)

Generic Drug Cluster

International Coalition of Medicines Regulatory Authorities (ICMRA)

International Council for Harmonisation (ICH)

International Medical Device Regulators Forum (IMDRF)

International Pharmaceutical Regulators Programme (IPRP)

International Medical Device Regulators Forum (IMDRF)

International Regulatory Cooperation for Herbal Medicines (IRCH)

Medical Device Single Audit Program (MDSAP)

International Regulatory Cooperation for Herbal Medicines (IRCH)

Access Consortium

Canada-United States Regulatory Cooperation Council (RCC)

Project Orbis

Generic Drug Cluster

World Health Organization

Bilateral Partnerships

International Coalition of Medicines Regulatory Authorities (ICMRA)

Formed in 2014, the ICMRA is a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of regulatory authorities that work together to:

address current and emerging human medicine regulatory and safety challenges globally, strategically and in an ongoing, transparent, authoritative and institutional manner

provide direction for areas and activities common to many regulatory authorities' missions

identify areas for potential synergies

wherever possible, leverage existing initiatives/enablers and resources

The ICMRA provides a global architecture to support enhanced communication, information sharing and crisis response, and to address regulatory science issues.

Health Canada is a member of the ICMRA and participates in a number of its committees and working groups.

Get the latest

ICMRA news

in the recent content section of the

ICMRA website

.

International Council for Harmonisation (ICH)

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was formed in 1990 to bring together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception, the ICH has gradually evolved to respond to the increasingly global nature of drug development. The ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

Health Canada is a full member of the ICH and participates in many of its committees and working groups.

More detail on ICH activities can be found on the

Health Canada ICH web page

and the

ICH website

.

International Pharmaceutical Regulators Programme (IPRP)

The IPRP was launched on January 1, 2018, following a decision to merge the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP). The IPRP creates a forum for its members and observers to exchange information on issues of mutual interest and enable cooperation. It will be a regulatory hub for pharmaceuticals that covers all medicinal products, simplifying the numerous forms of international regulatory collaboration.

Health Canada was chosen as the first chair of the new IPRP, and participates in many of its committees and working groups.

More detail on the IPRP can be found on the

IPRP website

.

International Medical Device Regulators Forum (IMDRF)

Formed in 2011, the IMDRF is a voluntary group of medical device regulators from around the world. Their goal is to accelerate international medical device regulatory harmonization and convergence, promoting an efficient and effective regulatory model for medical devices that is responsive to emerging challenges in the sector while protecting and maximizing public health and safety.

IMDRF's objectives are to:

accelerate international medical device regulatory convergence

support innovation and timely access to safe and effective medical devices globally

promote open discussion and the sharing of best practices among regulatory authorities responsible for medical device regulation

facilitate frequent exchange of policy and regulatory information of common interest to regulatory authorities

provide opportunities to identify commonalities and develop approaches to overcome unnecessary regulatory barriers

promote prospective convergence in areas of advanced and innovative technologies

enhance communication, information sharing and scientific exchange among regulators and a broad range of stakeholders

establish develop dialogue with other relevant organizations

More detail on IMDRF can be found on the

IMDRF website

.

Medical Device Single Audit Program (MDSAP)

The MDSAP was initiated at the International Medical Devices Regulators Forum's (IMDRF) inaugural meeting in Singapore in 2012. The program was designed and developed so that a single audit, performed by an authorized Auditing Organization, meets the quality management system requirements of multiple regulatory agencies, derived from the International Organization for Standardization (ISO) 13485:2016. Employing a single audit program allows regulatory agencies to efficiently leverage resources, reduce regulatory burden on industry without compromising public health, and promote more aligned and consistent technical requirements, among other benefits. In addition to Health Canada, the participating agencies are the Australian Therapeutic Goods Administration (TGA), the Brazilian Agência Nacional de Vigilância Sanitária (ANVISA), the Japanese Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), and the United States Food and Drug Administration (FDA).

More detail on the MDSAP can be found on the

Health Canada website

and on the

FDA website

.

International Regulatory Cooperation for Herbal Medicines (IRCH)

The IRCH is a World Health Organization (WHO) network that was established in 2006 to globally promote and facilitate the safe use of herbal medicines through the sharing of information and fostering of dialogue. The objective and scope of IRCH is to recognize the relevance of national context, capacity, priorities and legislations, to facilitate and strengthen cooperation between members by sharing experience, information and knowledge related to the regulatory frameworks and other important issues governing the safety, quality and efficacy of herbal medicines.

Membership is open to any national regulatory authority responsible for the regulation of herbal medicines and regional/sub-regional bodies responsible for the regulation of herbal medicines.

Health Canada is the designated representative for Canada on the IRCH.

More detail on IRCH can be found on the

WHO IRCH website

.

Access Consortium

The Access Consortium was established in 2007 and consists of health regulatory agencies from:

The

Therapeutic Goods Administration

(TGA) of Australia

The Health Products and Food Branch (HPFB) of Health Canada, Canada

The

Health Sciences Authority

(HSA) of Singapore

Swissmedic

, Swiss Agency for Therapeutic Products, of Switzerland

The

Medicines and Healthcare products Regulatory Authority

(MHRA), of the United Kingdom (U.K.) (

joined on October 14, 2020

)

The Consortium was established to foster regulatory collaboration to address emerging scientific and regulatory issues regarding health products and to leverage resources and expertise.

Up until 2010, regulatory collaboration under the Consortium had focused on information sharing between agencies. Since then, the Consortium has moved beyond information sharing to actual work sharing where working groups were created to stimulate work sharing on important issues.

The Access Consortium's work focuses on regulatory work sharing initiatives as well as information sharing on issues including but not limited to:

New Active Substances/ Benefit Harm Risk

Generic Medicines

Information Technology

Complementary Health Products

Biosimilars

Collaboration on International Council for Harmonization (ICH) expert working groups

More detail on the Access Consortium can be found on the

Access web page

.

Bilateral Partnerships

To support international collaboration including information and work sharing, Health Canada relies on confidentiality arrangements and memoranda of understanding with our counterpart regulatory agencies in other jurisdictions. A complete list of our confidentiality arrangements and memoranda of understanding can be found on the

HPFB international collaborative arrangements web page

. These partnerships help to advance the effective regulation of health products and promote timely access to new drugs and medical devices.

Recently, Health Canada approved a new drug for the treatment of prostate cancer. This drug was jointly reviewed with the Therapeutic Goods Administration (TGA) of Australia. This joint-review initiative is aimed at strengthening our international partnerships in submission review and enabling a prompt authorization of drug products to allow Canadians to have faster access to the medicines they need. As a result of the success of this pilot, other drug submissions currently in queue, or soon to be submitted by industry, are being considered for further collaboration with the TGA.

Health Canada also participates in regular "Cooperation Cluster" meetings with international counterparts including the United States Food and Drug Administration, the European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency of Japan. These meetings allow for the exchange of scientific information regarding complex regulatory decisions related to pre-market product submissions. Health Canada actively participates in clusters on several topics, including oncology, blood, advanced therapy medicinal products, blood, vaccines, biosimilars, and veterinary drugs. Health Canada is also an observer on the paediatric, pharmacovigilance and cardiovascular clusters.

Canada-United States Regulatory Cooperation Council (RCC)

On February 4, 2011, Canada and the United States jointly announced the creation of the Canada-United States Regulatory Cooperation Council (RCC) to increase regulatory transparency and coordination between the two countries.

The RCC has included many successful initiatives, including the implementation of the Common Electronic Submission Gateway,

joint public consultation meetings

on ICH guidelines currently under development, and parallel reviews of certain veterinary drugs.

Health Canada and the United States Food and Drug Administration have established work plans on:

Pharmaceuticals and Biological Products

Over-the-Counter Products

Medical Devices

Veterinary Drugs

More detail on RCC initiatives, including work plans, can be found on the

Regulatory Cooperation Council (RCC) web page

.

Project Orbis

Project Orbis is an international partnership designed to give cancer patients faster access to promising cancer treatments.

Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. It aims to give patients faster access to promising cancer treatments across the globe.

Health Canada has been a partner in Project Orbis since its start in May 2019. Health Canada worked with the FDA and TGA on the first Project Orbis submission. This led to Health Canada’s expeditious approval of a

treatment for women with advanced endometrial cancer

in September 2019. Since then, Health Canada has participated in many Project Orbis submissions.

More detail on Project Orbis can be found on the

Project Orbis web page

.

Generic Drug Cluster

As of June 2021 Health Canada is pleased to be participating in the Generic Drug Cluster, which was launched by the U.S. Food and Drug Administration (FDA). Through this forum Health Canada aims to increase scientific alignment and harmonization between regulatory agencies surrounding generic drug development and regulation.

The objectives of the Generic Drug Cluster include the following:

Achieving a common understanding of each Agency's regulatory requirements for approval and current thinking on topics related to generic drug development through information sharing on approval requirements and recommendations conveyed in guidance documents.

Offering a confidential forum for the exchange of information on policies in development, including draft guidances for industry, and the scientific basis for decisions on those policies.

Provision of a forum for discussions on general and product/class-related scientific review issues and fostering alignment in approaches to scientific evaluation whenever possible.

Addressing long-term safety issues to ensure a global safety net for generic drugs through confidential sharing of reports.