Event summary: Health Canada's stakeholder update on health products
January 13, 2022

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On January 13, 2022, Health Canada's Health Products and Food Branch (HPFB) held its annual stakeholder update on health product highlights and priorities.

Over 375 stakeholders took part in the virtual session, including representatives from industry associations, academia, patient and consumer groups, health practitioners, and advocacy and non-governmental organizations. Health Canada employees and representatives of other federal government departments and agencies, such as the Public Health Agency of Canada also attended.

Presentation: Health product highlights and priorities

Dr. Stephen Lucas, Deputy Minister of Health Canada, opened the session by recognizing the challenges the COVID-19 pandemic has presented for Canadians and the healthcare sector both domestically and abroad. He expressed his gratitude for the collective commitment to continuous improvement and innovation that has helped enable access to safe, effective and high-quality health products to respond to COVID-19. Dr. Lucas also spoke about broader Health Canada priorities such as the National Strategy for Rare Diseases, working with the provinces and territories to make high-quality mental health services more accessible to Canadians who need them, and the Government's commitment to building more research and biomanufacturing capacity in Canada.

Nancy Hamzawi, Assistant Deputy Minister of HPFB echoed her appreciation for all the hard work done through the pandemic and presented the key achievements of the branch in 2021 along with priorities moving into 2022.

The COVID-19 pandemic has required a whole of government approach - working closely with federal and provincial/territorial partners - to ensure access to the COVID-related products Canadians needed. Key highlights of 2021 include the approval of COVID-19 testing devices and treatments, as well as vaccines including a pediatric formulation for children ages 5 to 11.

The Government of Canada's pandemic response has included heightened international collaboration through rapid sharing of information in the context of the evolution of the virus, while aligning and collaborating on regulatory and policy approaches. This work is ongoing as the situation continues to evolve, shifting focus to the next generation of vaccines, testing devices, treatments and other COVID-related products.

The regulatory agilities that Health Canada put in place via interim orders have been extended to maintain flexibility and regulatory oversight, and continue to ensure that Canadians have access to COVID-19 related products.

Despite the operational demands of the pandemic, Health Canada has continued to make progress and advance on key priorities, including:

Armchair discussion: Advancing international collaboration to improve access to health products

Panelists from Health Canada, the U.S. Food and Drug Administration (US FDA), and the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA) shared their perspectives on the importance of international collaboration to support access to drugs and medical devices in Canada and around the world.

Leading international collaboration

Over the years, Health Canada has built strong bilateral relationships while also participating in multilateral organizations with international regulatory counterparts to support enhanced communication and information sharing on key regulatory issues.

For example, Health Canada has taken on a leadership role with the International Coalition of Medicines Regulatory Authorities (ICMRA), co-chairing the COVID-19 working group with the UK MHRA to foster rapid information exchange and help develop a global approach to regulating COVID-19 treatments and vaccines. Health Canada is also a leader within the Access Consortium, collaborating to advance the regulatory science needed to support the rapid development of diagnostic tests, as well as vaccines and treatments against COVID-19.

In addition, Health Canada is an active member in several other collaborative product review initiatives such as the Medical Device Single Audit Program, EMA Open, and Project Orbis. These relationships support access to needed health products to enter the Canadian market within a shortened timeframe, while maintaining our high standards for safety, efficacy, and quality.

Collaborating through the COVID-19 pandemic

The need for health products related to the COVID-19 pandemic has propelled international collaboration to a new level. Throughout the COVID-19 pandemic, Health Canada has built on its strong international relationships to ensure that approaches are aligned, effective, and products are made available quickly. This has included ramping up discussions and resources on issues related to clinical trials, drug and medical device market authorizations, risk assessments, and potential drug and medical device shortages.

The US FDA emphasized the importance of working collaboratively during the onset of the pandemic with key partners such as Health Canada, UK MHRA and the World Health Organization in order to determine policy recommendations, and address health product shortages.

Regulatory agility

In Canada, the pandemic provided an opportunity to test a number of agile approaches including rolling submissions, the use of terms and conditions on product authorizations, as well as decentralized multinational trials.
The UK MHRA expanded on the many advantages of engaging in international collaboration efforts alongside Health Canada and the US FDA to accelerate market access for quality innovative products and provide evidence-based authoritative information.

Enhancing post-market surveillance

The pandemic has emphasized the need for enhanced post-market surveillance to monitor the safety and effectiveness of COVID-related products, including working with international partners. Through information-sharing networks, participating agencies exchange information on COVID-19 post-market safety issues and, as a result, are able to issue important joint-statements and communications in a timely manner.

Path forward in advancing international strategic priorities

The participants recognized the importance of continuing to build on these critical relationships.

Discussion participants agreed that there is a need to:

The session closed with Health Canada's gratitude for and commitment to ongoing collaboration with stakeholders through these unprecedented times.

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