Innovative Medicines Canada (IMC): Final record of decisions May 12, 2021

Health Canada, Health Products and Food Branch (HPFB)
Bilateral Meeting Program
Virtual
May 12, 2021 1:00 p.m. to 3:00 p.m.

On this page

• Participants
• Meeting minutes
• Next meeting

Participants

IMC participants

• Lama Abi Khaled, Innovative Medicines Canada (Co-Chair)
• Lisa Chartrand, Hoffmann-La Roche Limited (Co-Chair)
• Lorella Garofalo, Pfizer Canada Inc.
• Martin Cloutier, Bristol-Myers Squibb Canada
• Neerja Goyal, GlaxoSmithKline Inc.
• Laura King, Novartis Pharmaceuticals Canada Inc.
• Christine Mossa, Ispen Biopharmaceuticals Canada
• Sandra Usik, Eli Lilly Canada Inc.
• Sandra Wainwright, Merck Canada Inc.
• Maggy Mouradian, Boehringer Ingelheim (Canada) Ltd.
• Melanie Groleau, Knight Therapeutics Inc.
• Anita Hammer, Amgen Canada
• Carrie Ku, Sanofi Canada
• Emily Roome, Innovative Medicines Canada

Health Canada participants

• John Patrick Stewart, Director General, Therapeutic Products Directorate (TPD), Co-Chair
• Ian Aldous, Bureau of Medical Sciences (BMS), TPD
• Rita Beregszaszy, Bureau of Policy, Science and International Programs (BPSIP), TPD
• Marc Berthiaume, BMS, TPD
• Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
• Michèle Chadwick, Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
• Heather Cherry, Regulatory Project Management Division (RPMD), TPD
• Mandy Collier, OPPRS, TPD
• Alysha Croker, Office of Pediatrics and Patient Involvement (OPPI)
• Heather Dodson, Regulatory Operations and Enforcement Branch (ROEB)
• Fiona Frappier, BRDD
• Émile Geoffroy, OPPRS, TPD
• Liz Anne Gillham-Eisen, BRDD
• Debra Haltrecht, Policy, Planning and International Affairs Directorate (PPIAD)
• Stephanie Hardy, BRDD
• Catherine Hudon, ROEB
• Alice Hui, Bureau of Metabolism, Oncology, and Respiratory Sciences (BMORS), TPD
• Melissa Hunt, BMORS, TPD
• Carole Légaré, Office of Clinical Trials (OCT), TPD
• Martin McLean, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
• Michelle Milne, ROEB
• Philippe Mineau, Director General’s Office, TPD
• Rania Mouchantaf, BMORS, TPD
• Scott Myres, Assistant Deputy Minister's Office (ADMO)
• Vincent Punch, BGIVD, TPD
• Chris Rose, Bureau of Pharmaceutical Sciences (BPS), TPD
• Jeffrey Skene, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
• Evelyn Soo, BGIVD, TPD
• David Southam, BRDD
• Emma Spreekmeester, BPS, TPD
• Elizabeth Toller, PPIAD
• Donna Watt, OPPRS, TPD

Meeting minutes

Welcome and opening remarks

John Patrick Stewart, Director General, Therapeutic Products Directorate, and Co-chair, welcomed participants to the third virtual bilateral meeting between Innovative Medicines Canada (IMC) and Health Canada. COVID-19 has continued to be a major priority since the last bilateral meeting in November of 2020. Dr. Stewart thanked IMC's members for working collaboratively with Health Canada to respond to the pandemic and to provide access to products that improve the health of Canadians. As part of the government's response to the pandemic, Health Canada introduced innovative and agile regulatory measures through the use of temporary Interim Orders. The department has now amended the Food and Drug Regulations to provide modified requirements for new COVID-19 drugs to receive a Notice of Compliance (NOC) through a new drug submission. Health Canada has also published a second Interim Order for COVID-19-related clinical trials to replace the one that will expire at the end of May 2021.

There have been a few organizational and senior management changes since the last bilateral meeting. Anik Michelle Chartrand has taken on a new position with the Canadian Coast Guard, and Chris Rose has been appointed to the position of Director of the Bureau of Pharmaceutical Sciences in TPD. Melissa Hunt, Director of the Bureau of Metabolism, Oncology and Reproductive Sciences, has joined the Marketed Health Products Directorate for a short-term assignment working on post-market issues related to vaccines. Dr. Rania Mouchantaf will fill in for her in the interim. Marilena Bassi is now Director General of the Veterinary Drugs Directorate and Bruce Randall has taken on her role as TPD's Senior Executive Director. Natalie Page is the new Director General of the Natural and Non-prescription Health Products Directorate.

Lama Abi Khaled, Co-chair of IMC's Regulatory Operations Team and Executive Director, Ethics, Legal and Regulatory at IMC thanked Health Canada for the continued engagement with industry. Ms. Abi Khaled noted that she has been with IMC for three years, but it was in September 2020 that she took on a more active role with the Regulatory Operations Team. The association is appreciative of the opportunity to have these bilateral meetings and to discuss key topics. IMC shared the three strategic pillars that guide its work:

1. Transforming Canadians lives through timely access to world class innovative medicines and vaccines;
2. Proactively contributing data driven policy advice to government that can shape the future and resiliency of the health system; and
3. Keeping credible and impactful data that reflects the value of the industry and the medicines and vaccines they produce.

This supports policy decisions that benefit patients and a healthy life sciences sector. IMC membership continues to grow and now represents 47 companies ranging from established organizations to fledgeling startups. IMC shared a report on The Canadian Research and Development Pharmaceutical Sector that was published on the Statistics Canada website on May 7, 2021.

Lisa Chartrand, Vice-Chair of IMC's Regulatory Operations Team, and Director, Regulatory, Strategy and Policy at Hoffmann-La Roche, highlighted the work of the association's team and their key priorities for the year. The three areas that IMC intends to focus on in 2021 are:

1. Advancing the streamlined integration of the Regulatory, Health Technology Assessment (HTA) and reimbursement systems to improve patient access to innovative medicines and vaccines.
2. Instilling the learnings from the COVID-19 experience to improve health systems through both regulatory innovation and other ecosystem innovations.
3. Shaping new levels of evidence, both from a Real-World Evidence and from a digital health technologies perspective.

A sub-group has been formed within IMC to look specifically at digital health technologies and the integration with its industry membership.

Review of the agenda

There were no significant changes to the agenda.

Approval of meeting notes of November 17, 2020 / previous action items

The action item from the previous bilateral meeting on November 17, 2020 was completed. The Record of Decisions was approved.

Work sharing and parallel review – update on guidance

Melissa Hunt, in her previous role as Director of the Bureau of Metabolism, Oncology and Reproductive Services (BMORS), TPD addressed this item. Over the past year, Health Canada and international partners have continued to build on collaborative review initiatives including the Access Consortium and Project Orbis with the United States Food and Drug Administration (FDA) Oncology Center of Excellence. Health Canada and regulatory partners meet regularly to discuss Access Consortium initiatives and have developed approaches to align timelines and reviews for submissions. With the joining of United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) into the Access Consortium, this brings the combined population of countries participating in the consortium to about 145 million. The Access Consortium New Active Substance Work Sharing Initiative (NASWSI) is a collaborative pathway for joint review of submissions across consortium regulatory agencies. Work-sharing across all five agencies of the consortium began in January 2021 and Health Canada is learning to integrate this new process. Sponsors can explore this pathway through filing an Expression of Interest. Health Canada is currently working with Access partners on joint guidance documents including updated Q&A and procedure documents.

Project Orbis is an international partnership designed to give cancer patients faster access to promising cancer treatments. The Health Canada website for Project Orbis provides further guidance to industry on the project, including: eligible products; steps to apply and specifics on Health Canada assessment of submissions; timelines; and how to seek a Health Canada priority review or advanced consideration for a Notice of Compliance with conditions (NOC/c). IMC requested clarification as to whether, with Orbis, companies will need to submit a Clinical Assessment Package (CAP) in order to achieve an accelerated review. TPD confirmed that Orbis, in itself, does not guarantee an accelerated pathway and that a CAP needs be submitted to accelerate the timeline of the review. Legislated timelines would remain 300 days if they are not classified as expedited reviews.

As of December 18, 2020, Health Canada has been participating in the pilot phase of the European Medicines Agency's (EMA) "Opening our Procedures at EMA to Non-EU authorities (OPEN)" project. This initiative makes it possible for trusted regulatory authorities outside of the European Union, such as Health Canada, to collaborate with the EMA. At this stage, regulators from Australia, Japan, Switzerland and the World Health Organisation are also participating in OPEN. More information on Health Canada's collaborative initiatives can be found at the following website: Health products international activities

IMC indicated that it appreciates Health Canada's efforts to work with its partners to continue to evolve and improve on the worksharing initiative. However, IMC noted that its members continue to receive duplicate questions. IMC indicated that it already sees fewer duplicate questions in Orbis but it is the Access Consortium stream that is the challenge. TPD responded that Access is different in that each application is unique. Health Canada appreciates IMC's flexibility in responding to the rolling questions because that has allowed the department to meet the obligations and the timelines of the Access Consortium. Health Canada is working to find the best way to manage its workload and to meet these obligations. TPD indicated that the Heads of Agencies of the Access Consortium see this as an important pathway for submissions that will ultimately provide patients with easier access to medications.

IMC also requested information on whether there will be efforts towards reviewing and reducing Canadian specific requirements now that Health Canada is part of the worksharing group. TPD responded that each regulatory jurisdiction has its own requirements. Health Canada is looking to modernize its regulatory framework and is interested in aligning with other regulators where possible. IMC indicated that the experience of its membership with the regulatory authority worksharing has been varied. In an effort to gain more insight into the experience from a manufacturer perspective, IMC has issued a formal survey to its member companies to obtain feedback on various elements of the experience. IMC anticipates sharing the results of this survey with Health Canada, along with some recommendations. Health Canada is looking forward to receiving IMC's feedback on the survey. Questions about international collaborations can be sent to the following Health Canada generic email account: hc.collaboration.sc@canada.ca.

Accelerated review of human drug submissions – update on guidance

IMC requested an update on the draft Guidance: Accelerated Review of Human Drug Submissions.

David Southam, A/Manager, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB), Biologic and Radiopharmaceutical Drugs Directorate (BRDD) and Stephanie Hardy, Interim Executive Director, BRDD addressed this item. The Accelerated Review Guidance document has been revised by the working group based on the comments received as part of the initial consultation period in 2019. Because of the extensive revisions to the initial draft, the challenges of integrating both the Priority Review and the Notice of Compliance with Conditions (NOC/c) into the new guidance, and the time that has passed since initial consultation, a second round of consultation on the revised draft is planned for summer 2021. The Working Group review of the external consultation feedback will take place in fall 2021 and the Accelerated Review Guidance document is expected to be finalized by winter 2022.

IMC indicated that it has been informed that the Canadian Agency for Drugs and Technologies in Health (CADTH) and the pan-Canadian Pharmaceutical Alliance (pCPA) are also planning to develop a prioritization framework. IMC requested information as to whether BRDD will be having conversations with CADTH and pCPA to ensure that the criteria is aligned with Health Canada. BRDD indicated that it has had a number of discussions with CADTH and l'Institut national d'excellence en santé et en services sociaux (INESSS) on some of its current policies and on aligned reviews. There are also ongoing discussions between CADTH, INESSS, and Health Canada senior management around various topics, including accelerated access to drugs. Health Canada will work to ensure that the policies integrate to the degree possible.

Pause the clock – a year in review

Michèle Chadwick, Co-Lead, Pause the Clock, Director, Office of Business Integration, Biologic and Radiopharmaceutical Drugs Directorate (BRDD) and Heather Cherry, Pause the Clock Working Group member, Regulatory Project Management Division, TPD presented this item. As of April 1, 2020, sponsors can use the "Pause the Clock" mechanism that enables the review clock to pause and resume during the pre-market review process. A sponsor can request an extension to respond to a Clarification Request. Pauses cannot be less than five days or more than 90 days per pause. Less than five days would be considered to be an extension without a clock pause. The non-active review time (clock pause period) is not counted against performance target standards. If advice from an External Advisory Body is required, the review clock will pause once the sponsor is notified by Health Canada. This is currently the only situation when the pause would be initiated by Health Canada.

The scope of Pause the Clock includes all human drugs (pharma, biologics, radiopharmaceuticals, non-Rx, disinfectants, including submissions under Priority Review/ NOC-C), veterinary drugs and medical devices. The following are out of the scope of this initiative: administrative submissions (such as name changes); applications for veterinary health products; any submissions in screening; acceptance of additional data during the review process; and joint reviews with other regulatory authorities because they follow pre-established processes. Health Canada is considering adding the ability to pause joint reviews. Post meeting note: As of July 7, 2021, joint reviews with other regulatory authorities are considered within scope of Pause the Clock. Pause the Clock information is available on the Health Canada website at the following link: Guidance Document: The Management of Drug Submissions and Applications - Canada.ca

IMC was provided with metrics for Pause the Clock Drugs for Human Use (April 1, 2020 to March 31,2021). For TPD, there have been 21 ANDSs (7% of total submissions) with an average pause time of 24 days per submission. There have been 6 SANDSs (1% of total submissions) with an average pause time of 38 days per submission. On average, there were 67 submissions for TPD, BRDD and NNHPD and the average pause time per submission was 23 days. The pauses occurred at all stages in review. In terms of Pause the Clock Drugs for Veterinary Use (April 1, 2020 to March 31, 2021), there were a total of 6 pauses with an average pause time of 48 days per submission. BRDD noted that Pause the Clock appears to be working well, especially with the new cost recovery structure and penalty model. Sponsors are using Pause the Clock more with TPD submissions than other directorates. All Pause the Clock requests have been granted in order to provide more time for sponsors to respond to requests.

Health Canada indicated that it is interested in hearing comments from IMC as to how the Pause the Clock process is working. IMC shared that it is pleased with the results of the metrics for what the outcome showed. IMC asked whether the insights gathered by Health Canada were in-line with initial expectations. BRDD responded that it had not expected that Pause the Clock would be used very much because, initially, sponsors did not warm to the idea. However, due to COVID-19 and the repercussions of the pandemic, the pause was used more often than anticipated and sponsors appreciated the initiative. BRDD noted that Pause the Clock has been useful but it is too early to tell whether it had an impact on the number of NONs and NODs that were issued as there were many different factors in play. It is anticipated that there will be a better measure of this over the longer term. Health Canada noted that Pause the Clock would only reduce the need to issue a NOD or NON when the reason for the decision is that more time is required to respond to a clarification request.

Health Canada's Pediatric Drug Action Plan (PDAP) / Scientific Advisory Committee on Health Products for Women (SAC-HPW)

Alysha Croker, Office of Pediatrics and Patient Involvement (OPPI) presented an update on this item. The vision of the Pediatric Action Plan (PDAP) is that children and youth (aged 0-17) in Canada obtain access to the medicines they need in age-appropriate formulations. Health Canada is currently working with CHU Sainte-Justine and the Goodman Pediatric Formulations Centre to improve access to pediatric formulations. To address the urgent need to provide Canadian children with access to pediatric formulations available in other countries, a pilot project was proposed. A workshop was held in February 2020 with diverse stakeholders (e.g., industry, regulators, pharmacists, payers, provinces/territories, clinicians, and Health Canada). The idea of the pilot is to bring together all of the groups involved in approving a product throughout the lifecycle to figure out a product-specific pathway through Health Canada, the reimbursement agencies and the payers so that sponsors would have the pathway mapped out for them. The process is currently being piloted with a pediatric formulation of Tacrolimus.

Health Canada was recently elected to the position of vice-chair of the World Health Organization's Paediatric Regulatory Network, where regulators from across the world come together to try to address global issues around access to medicine for children. Health Canada and the EMA have developed a pediatric workplan through the Regulatory Cooperation Forum which is designed to support international alignment in pediatric regulatory review, including aligned review processes. Health Canada is anticipating this will lead to reduced burden on industry, including potentially eliminating multiple requests for information from both regulators. Because access to medicines for pediatric populations is a global issue, Health Canada has been working with a number of international partners to try to tackle this issue. There are monthly EMA-FDA Pediatric Cluster meetings where the FDA and the EMA, along with Health Canada, Australia and Japan discuss issues related to pediatric medicines. Health Canada is exploring potential ways to work with its Access Consortium partners to increase access to pediatric medicines.

Health Canada is interested in working with IMC in the near future to understand the hurdles members face bringing both pediatric clinical trials and products to Canada. IMC indicated that while there continue to be significant barriers to bringing medicines to the Canadian pediatric populations, it is pleased that there is international collaboration in this area and it agrees that ensuring access to safe and effective medicines for pediatric populations in Canada is a priority. IMC noted as well that Health Canada should consult with the innovative industry early and ensure harmonization with other jurisdictions. It is anticipated that Health Canada will host a consultation with IMC and other industry stakeholders regarding pediatric regulation in Canada in Fall 2021.

Scientific Advisory Committee on Health Products for Women (SAC-HPW)

The Health Products and Food Branch (HPFB) recently established a Scientific Advisory Committee on Health Products for Women (SAC-HPW). The mandate of the committee is to provide Health Canada with timely patient-centered, scientific, technical, medical and clinical advice on current and emerging issues regarding women's health and the regulation of drugs and medical devices. The SAC-HPW meetings that have been held so far have covered a number of topics such as: post-market activities and recalls related to breast and mesh implants, including patient experiences; advising Health Canada and the National Advisory Committee on Immunization (NACI) on the need to prioritize COVID-19 vaccine roll-out to vulnerable populations, including women in long-term care facilities; and providing advice around a ICH reflection paper proposal related to designing more inclusive clinical trials. Health Canada expects clinical trials be conducted in the populations who are expected to use the product. The department noted that it will be seeking the SAC-HPW Committee's advice on aspects of policy, regulations, guidance to industry regarding submissions, and labelling.

Health Canada regulatory innovation and interim order transition

Elizabeth Toller, Associate Director General of PPIAD, and Executive Director, Regulatory Innovation, Health Products and Food Branch; Rita Beregszaszy, Director, Bureau of Policy, Science, and International Programs, TPD; Liz Anne Gillham-Eisen, Director, Office of Policy and International Collaboration (BRDD); Debra Haltrecht, Director, Office of Legislative and Regulatory Modernization, PPIAD; and Catherine Hudon, Director, Policy and Regulatory Strategies Directorate, Regulatory, Operations and Enforcement Branch (ROEB) addressed this item.

IMC indicated that Interim Orders were a welcome tool that has served Canadians well during the pandemic, especially as they helped ensure that Canada kept pace with international jurisdictions. The association requested an update on the comments it provided for the consultations that were held for the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD IO). BRDD indicated that the comment period ended on April 30, 2021 and that comments were received from a number of different individual sponsors, manufacturers, as well as associations. A Working Group is reviewing the comments and the Guidance Document is expected to be re-issued in Spring 2021. A number of the comments relating to specific cases could be answered in a pre-submission meeting or by direct response instead of an amendment to the guidance. BRDD reconfirmed that the guidance is final and the only changes that will be made at this point is the addition of a few points of clarity to enhance the reader's understanding. The guidance is meant to be a general overview. IMC appreciated that Health Canada is open to engagement on the topic. IMC noted that the concept of rolling submissions for this Interim Order seems to have been well received by IMC members overall.

With the transition regulations and the accompanying Guidance Document, a new category has been created for the New Drug Submission with flexibilities for Designated COVID-19 drug (NDS CV). It is IMC's understanding that a company would choose this category if it needs to apply one of the three flexibilities (not having a full data package or a rolling submission or not providing mockups). IMC requested clarification on whether a company that is planning to file an NDS for a COVID-19 product and is interested in receiving an expedited review and pre-positioning but does not need to make use of the three flexibilities could file it as an NDS CV.

Action: Liz-Anne Gillham-Eisen, BRDD, to reconfirm if an NDS for a COVID-19 product that does not need to make use of the flexibilities could be filed as an NDS CV.

Update: Yes, if the company wants to engage in prepositioning this is possible for any COVID-19 product. They do need to have a pre-purchasing contract in place and they do need to have a submission under review. Prepositioning allows for the importation into Canada while the product remains under review. This is outlined in Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19. As to the question of an expedited review, this would require a NDS-CV application. Under the regular Division 8 the product would be eligible as a priority review. This is outlined in Guidance for Industry - Priority Review of Drug Submissions. The response was provided to IMC on July 6, 2021.

Regulatory modernization

Health Canada is committed to moving forward with its modernization plans. The COVID-19 pandemic has delayed some initiatives but it has been a good opportunity to test out ways to be more agile in the future. Health Canada has three large regulatory modernization initiatives that are on the horizon. First, a policy paper on the clinical trial modernization proposal will be published on the Health Canada website in May 2021. Second, Health Canada will engage further with industry in regard to the Agile Licensing Project, including around the Terms and Conditions. A consultation could be as early as summer. Third, Health Canada is making progress on the Advanced Therapeutic Products (ATP) pathway and is considering a first regulatory sandbox that could potentially focus on machine learning Artificial Intelligence (AI) devices. IMC indicated that CADTH is also considering starting a digital health working group. PPIAD noted that it is having conversations with CADTH and INESSS about the various products that are on the horizon, including machine learning AI products. Health Canada intends to establish an external reference group for each regulatory sandbox and will invite CADTH and INESSS to participate. IMC indicated that it looks forward to the opportunities for future consultations. As these elements are implemented, IMC is interested in how to measure success and hoping to continue the conversation with Health Canada around metrics as having this data is important to the association.

Update: The Clinical Trials Modernization: Consultation Paper was posted on the Health Canada website on May 20, 2021 and comments will be welcomed until July 4, 2021. For TPD to meet its regulatory development and Canada Gazette I timelines, the consultation cannot be extended longer than 45 days. TPD reassured IMC that it is planning to have targeted discussions with stakeholders on the topic and there will be separate discussions with industry, likely by product line. IMC noted that it is looking forward to having the dedicated time for discussion. The association indicated that it will be presenting its clinical trial recommendations at the consultation on clinical trial regulations that will be held during the Canadian Association of Professionals in Regulatory Affairs (CAPRA) meeting on May 18 and 20, 2021. TPD indicated that it has reached out to sponsors who have filed clinical trials during COVID-19 in order to determine why they chose to file under the Interim Order. Responses provided will help guide the development of the regulatory modernization framework. Health Canada is working closely with Health Technology Assessment (HTA) partners and the pan-Canadian Pharmaceutical Alliance (pCPA) as a part of the consultations on the agile licencing proposal, especially around Terms and Conditions and how they will be used.

IMC requested information on whether there would be any opportunity to have further dialogue with downstream partners so that the new policies and the flexibilities that Health Canada is introducing will be supported and will work in coordination to facilitate patient access to medications. TPD responded that Health Canada is actively engaged with a number of partners such as the Canadian Association of Research Ethics Boards, the Canadian Institutes of Health Research, as well as provincial/territorial representatives. The clinical trial modernization consultation process includes not only industry but also other stakeholders in the health system in order to gather different perspectives. Health Canada's vision for Advanced Therapeutic Products (ATPs) is to bring in the downstream partners such as HTAs, buyers, users, and hospitals from the beginning so they can help determine the appropriate evidence requirements for these new, innovative, and complex technologies.

IMC suggested that the scope of modernization be broadened so that the transition of the Interim Orders into the Food and Drug Regulations could be extended beyond the COVID-19 product. Health Canada is exploring how to broaden the scope of modernization to include products that are not related to COVID-19, where possible. TPD and the Regulatory Operations and Enforcement Branch (ROEB) are working with the International Coalition of Medicines Regulatory Authorities (ICMRA) to ensure that Health Canada will be able to leverage the regulatory flexibilities that were implemented during COVID-19 in the future.

Round table

Labelling

IMC requested a joint meeting with the labelling groups in TPD and BRDD to discuss concerns such as the number of mock-up requests during review and the timeframe (number of days from request to submission).

Action: Evelyn Soo, Director of Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD to have a joint meeting between IMC and the labelling groups in BGIVD, TPD and BRDD.

Action completed: The meeting was held on June 23, 2021.

Closing remarks and adjournment

John Patrick Stewart, TPD, thanked everyone for their contributions, their engagement and their participation and Lama Abi Khaled and Lisa Chartrand, IMC, for being co-chairs. Dr. Stewart indicated that these meetings lead to Health Canada improving as a regulator to meet the needs of both Canadians and industry. Lama Abi Khaled and Lisa Chartrand, IMC, thanked Health Canada for taking the time to participate in this third virtual bilateral meeting. The association appreciates these bi-annual interactions as well as the updates that have been provided. IMC is looking forward to further deeper discussions and consultations as these initiatives move forward.

The meeting was adjourned at 3:00 PM.

Next meeting

Fall 2021

Signed by:

John Patrick Stewart
Director General
Therapeutic Products Directorate