Canadian Generic Pharmaceutical Association (CGPA): Final record of decisions June 3, 2021

Health Canada, Health Products and Food Branch (HPFB)
Bilateral Meeting Program
Virtual
June 3, 2021 1:00 p.m. to 3:50 p.m.

On this page

• Participants and observers
• Meeting minutes
• Next meeting

Participants and observers

GGPA participants

• Duane Terrill, Apotex (Co-chair)
• Anne Wilkie, CGPA
• Jim Keon, CGPA
• Sandra D'Agostino-Ferlisi, Apotex
• Swamy Subramanian, Apotex
• Rana Harb, Auro Pharma
• Barbara Bednarek, Frenesius Kabi
• Diana Wanes, Fresenius Kabi
• Sneha Thakkar, Marcan
• Suresh Arvapalli, Marcan
• Joanne Manley, Viatris
• Sukhvir Hundal, Viatris
• Alexandra Comlosan Pop, Viatris
• Josephine Wong, Natco Pharma
• Nadim Dinani, Natco Pharma
• Deirdre Cozier, Pharmascience
• Kent Major, Pharmascience
• Sonia Gallo, Sandoz
• Mauricio Ede-Filho, Sandoz
• Karen Patrick, Sterimax
• Lul Ogba-Ghebriel, Taro
• Alpa Jani, Teva
• Mathi Mathivanan, Teva
• Doug Wylie, Teva
• Maria Kalamara-Salonikidis, Baxter Corporation

Health Canada participants

• John Patrick Stewart, Director General, Therapeutic Products Directorate (TPD), (Co-chair)
• Bruce Randall, Senior Executive Director, TPD
• Sandra Alderdice, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
• Ian Aldous, Bureau of Medical Sciences (BMS), TPD
• Scott Appleton, Bureau of Pharmaceutical Sciences (BPS), TPD
• Rita Beregszaszy, Bureau of Policy, Science and International Programs (BPSIP), TPD
• Isabel Brazeau, Regulatory Project Management Division (RPMD), TPD
• Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
• Michèle Chadwick, Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
• Heather Cherry, RPMD, TPD
• Gary Condran, BPS, TPD
• David Duguay, Marketed Health Products Directorate (MHPD)
• Mohammed Faisaluddin, RPMD, TPD
• Emile Geoffroy, OPPRS, TPD
• Debra Haltrecht, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)
• Melissa Jean, Resource Management and Operations Directorate (RMOD)
• Laura Johnson, OPPRS, TPD
• Trish Larwill, RMOD
• Marc Legrand, BPSIP, TPD
• Carole Légaré, Office of Clinical Trials (OCT), TPD
• Christine Leroux, OPPRS, TPD
• Ranjeet Massey, Health Product Compliance Directorate (HPCD), Regulatory Operations and Enforcement Branch (ROEB)
• Natasha Rastogi, BPSIP, TPD
• Bruno Rodrigue, OLRM, PPIAD
• Jeffrey Skene, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
• Andrew Slot, BCANS, TPD
• Emma Spreekmeester, BPS, TPD
• Christine Taillon, HPDD, ROEB
• Donna Watt, OPPRS, TPD
• Melanie Whiteside, BGIVD, TPD
• Bruce Wozny, MHPD
• Veronica Yip, BGIVD, TPD
• Toufic Zayoun, HPCD, ROEB

Observers

• Eun Hye Kang, RPMD, TPD
• Sabrin Salmin, RPMD, TPD

Meeting minutes

Welcome and introductions

John Patrick Stewart, Director General, Therapeutic Product Directorate (TPD) welcomed everyone to the virtual bilateral meeting. COVID-19 has continued to be a major priority since the last TPD/CGPA bilateral meeting on December 1, 2020. TPD thanked CGPA's members for their ongoing collaboration in responding to the pandemic, helping to find solutions and providing access to products that improve the health of Canadians. As part of Health Canada's response to the pandemic, it had introduced innovative and agile regulatory measures through the use of temporary Interim Orders. Health Canada is now moving to transition the temporary measures into longer-term solutions. In March 2021, the department amended the Food and Drug Regulations to provide modified requirements for new COVID-19 drugs to apply for a Notice of Compliance (NOC) through a new drug submission process. A second Interim Order for COVID-19-related clinical trials has been published to replace the one that expired.

There have been a few organizational and senior management changes. Anik Michelle Chartrand has taken on a new position with the Canadian Coast Guard, and Chris Rose has become the 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 and Dr. Rania Mouchantaf is filling in for Melissa. Natalie Page is the new Director General of the Natural and Non-prescription Health Products Directorate.

Duane Terrill, CGPA Co-chair, Director of Regulatory Affairs at Apotex and the Chair of the CGPA Scientific Affairs Committee, indicated that CGPA appreciates the opportunity to meet with Health Canada and to engage in discussions that are relevant to the industry. He thanked TPD for collaborating with its members during the difficult pandemic time. Mr. Terrill announced that Baxter Corporation has joined the association and welcomed Maria Kalamara-Salonikidis as the company's representative. CGPA looks forward to working with Chris Rose, the new Director of the Bureau of Pharmaceutical Sciences, TPD. The association is interested in receiving updates on the Access to Generics package and the regulatory innovation agenda with regards to the generic industry. CGPA expressed concerns about the current requirements for risk assessments and testing for nitrosamines and the potential impact on the supply of generic medicines and also the proposed revisions to the Patented Medicines (Notice of Compliance) Regulations as linked to the Access to Generics regulatory package published in Canada Gazette I. It was noted that the meeting would be recorded to facilitate the drafting of the minutes, but that the recording would be deleted once the minutes were written.

Review of agenda

There were no changes to the agenda.

Approval of meeting notes action items of the June 4, 2019 meeting

The action item from the December 1, 2020 meeting were completed and the Record of Decisions was approved.

Regulatory proposals updates

Access to generics package

Rita Beregszaszy, Director of the Bureau of Policy, Science and International Programs, TPD provided an update on this item. The Improving Access to Generics Regulatory Proposal was pre-published in the Canada Gazette, Part I, on March 30, 2019. This package indicates what Health Canada considers may be acceptable as an Abbreviated New Drug Submission (ANDS). It clarifies the regulatory requirements under the ANDS pathway for generic drug products containing different salt forms of the medicinal ingredient in comparison to the Canadian Reference Product (CRP). The Canada Gazette I regulatory package indicated that the reference to the medicinal ingredient refers to the form that is present in the final dosage form and could be based on input data.

Concern was expressed by CGPA that this may not align with the Justice Kane decision. TPD responded that with regards to the medicinal ingredient, there could be potential safety and efficacy concerns if there is a change in the form of the substance that was in the Active Pharmaceutical Ingredient (API) at the input stage as a result of its conversion to a finished dosage form. The finished dosage form is the form that ultimately goes to the patient. CGPA noted that the ultimate goal is to ensure a safe and effective product for the patient. A more detailed discussion on this topic is planned for the CGPA/Bureau of Pharmaceutical Sciences, TPD meeting on July 6, 2021.

CGPA expressed concern about the perception of difference when there is a formulary substitution. For example, if a salt in a product does not have the identical label, provincial formularies may be hesitant, even if it states that it is the equivalent product on the Notice of Compliance (NOC). TPD indicated that these considerations were taken into account. If a product is approved by Health Canada through an Abbreviated New Drug Submission (ANDS) pathway, it has the same safety and efficacy. Prior to publication in Canada Gazette I, Health Canada solicited early feedback from the provinces which indicated that they would welcome a regulatory framework for different salts.

CGPA expressed concern about regulations led by Innovation, Science and Economic Development Canada (ISED) that were moving forward in association with this package. CGPA indicated that it had not been informed about a regulatory change to the Patented Medicines (Notice of Compliance) Regulations which appeared in Canada Gazette I. CGPA noted that this would allow more patents to be listed on the Health Canada patent register which could potentially be used by innovators to block or delay generic access. ISED hosted a consultation with stakeholders on the topic and is in the process of reviewing the comments.

The two Guidance Documents that will be published to accompany these regulatory amendments are: Identifying and Labelling Medicinal Ingredients and Strength of New Drug Products and Generic Drug Equivalence: Medicinal Ingredients. The Canada Gazette II package and the Guidance Documents are anticipated to be released in Spring 2021 with a delayed implementation period of 90 days. CGPA noted that it is pleased that the labelling update will apply to both innovative and generic products and that the label referenced on the generic label should be equivalent to how it is referenced on the brand. CGPA indicated that the definition of medicinal ingredient should be identified as the input ingredient rather than as the final dosage form as the latter will present several challenges for its members. TPD is planning to continue the dialogue on this topic with CGPA.

Proposed new pharmaceutical alternative submissions pathway

Health Canada is interested in developing a separate pathway for generics that do not meet the requirements of the ANDS pathway and is expecting to enable that in the Food and Drug Regulations. HPFB considers all of the product lines, innovator and generics, and wants to ensure that every group of products receives fair consideration. Given the complexity of the undertaking from a policy and regulatory analysis point of view, this will take time to develop.

Agile regulation for licensing drugs initiative

Debra Haltrecht, Director in the Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD) provided an update. Over the last year, resources needed to be redirected to the COVID-19 response which has delayed the timing for the implementation of this initiative. The COVID-19 pandemic has reinforced the importance of regulatory agility to enable timely access to needed health products and provided an opportunity to test certain agile measures such as Terms and Conditions. Health Canada is considering taking a phased approach for the Agile Regulations for Licensing Drugs initiative. The first phase would prioritize immediate needs and build upon the regulatory agilities successfully piloted through the COVID-19 Interim Orders. Consultations on the regulatory policy, as well as cost-benefit impacts, could start as early as Summer 2021. Health Canada is considering CGPA's request that the Abbreviated New Drug Submission (ANDS) pathway be broadened so that generic products can be marketed in a timelier manner. As this is complex and would require significant changes to the Food and Drug Regulations, Health Canada will need to take an in depth look at the topic and determine what changes are viable.

Amendments to C.01.011(4) Schedule B

TPD indicated that amendments to C.01.011(4)/Schedule B and the mandatory standard declaration will be considered in future regulatory packages.

Update on international activities

Emma Spreekmeester, Associate Director, Bureau of Pharmaceutical Sciences, TPD, presented this item. The level of international collaboration has been unprecedented during the

COVID-19 pandemic, through bilateral collaboration as well as leveraging resources with the World Health Organization (WHO), the International Coalition of Medicines Regulatory Authorities (ICMRA), the Pan American Health Organization (PAHO), and the Access Consortium. Health Canada has been part of the European Medicines Agency's OPEN pilot project since December 2020. Through this pilot, Health Canada has been able to participate in the European Medicines Agency's (EMA's) assessment process for COVID-19-related medicinal products, and has already benefitted from participating in the discussions held during EMA's review of various COVID-19 products. Further information is available on the following Health Canada webpage: Health Canada's regulatory response to COVID-19: International engagement.

Over the past year, Health Canada and international partners have continued to build on collaborative review initiatives such as the Access Consortium which provide new options to support timely access to drugs. The Generics Medicines Work Sharing Trial was expanded to be applicable to all products and was renamed the Generic Medicines Work Sharing Initiative in 2020. There have been conversations between the various countries and their models for reviewing generic products and where to best place their collaborative efforts. The joining of the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom on October 14, 2020 significantly increased the population base of the Access Consortium. Canadian specific requirements are actively being discussed. The FDA has invited Health Canada to be part of a newly-created discussion group that will look at generic products. Health Canada is interested in having products come into Canada as soon as they are available. However, Health Canada prefers to focus on aligned or collaborative reviews as opposed to waiting for the use of foreign reviews.

Overview of Health Canada's international collaboration on nitrosamines

As the nitrosamine issue is global and the science continues to evolve, Health Canada has taken the lead to chair monthly Nitrosamine International Strategic Working Group (NISG) meetings with other key regulators to share new information, align communications to industry, and shape best practices. The World Health Organization (WHO) and the Brazilian Health Regulatory Agency (ANVISA) were welcomed as the newest members of the NISG on March 24th and May 12th, 2021 respectively. Key topics for the May 12, 2021 teleconference included updates such as: the status of notifications regarding the completion of risk assessments; drugs of interest; safety and quality; recent stakeholder events; and future engagements with industry.

The Nitrosamine International Technical Working Group (NITWG) chaired by Health Canada is a consortium of eight regulatory agencies (including Health Canada), the World Health Organization (WHO) and the European Directorate for the Quality of Medicines (EDQM). The Working Group focuses on addressing emerging nitrosamine technical and regulatory issues, particularly quality and safety concerns. Health Canada aims to develop harmonized approaches for acceptable intake limits, risk mitigation and root causes. A number of Working Group members have had consultations or Q&A sessions with industry. Health Canada hopes that, at some point in the future, there will be a forum such as ICH where industry is at the table. CGPA is interested in being included in these discussions. International regulators recognize the importance of having a harmonized approach with respect to the risk management of the nitrosamine impurities. There was general agreement that there is insufficient data on nitrosamine formation to move the subject to ICH so topics for harmonization (e.g. acceptable limits for impurities) will continue to be discussed at future technical Working Group meetings. Health Canada is dedicated to working with its international partners and bringing the feedback it has received from stakeholders to the table with the ultimate goal of aligning on these issues.

Nitrosamine contaminants

Emma Spreekmeester, Associate Director, and Gary Condran, Bureau of Pharmaceutical Sciences, TPD, Ranjeet Massey, Associate Director, and Toufic Zayoun, Manager, Health Product Compliance and Risk Management, Health Product Compliance Directorate (HPCD), Regulatory Operations and Regions Branch (ROEB) addressed this item. Health Canada acknowledges the growing scope of the nitrosamine issue in human pharmaceuticals, the impact on the global and domestic pharmaceutical industry, and the important role stakeholders and regulators have for delivering critical drugs to patients. CGPA indicated that nitrosamines are a high priority item for industry as well. CGPA noted that the needs of its members are unique from those of the innovator and the Over-the-Counter drug sponsors with regard to the spectrum of the products that they carry, the number of prescriptions they fill, and the number of sources they have for materials. CGPA is interested having discussions with Health Canada about the application of limits and the calculations of limits when there are multiple nitrosamines. CGPA noted that the different approaches that are taken by each agency are challenging for its members.

CGPA understands the need for a risk assessment if a product with a dormant DIN status is still on the Canadian market within expiry. However, if the last lot release has expired, the association suggested that dormant DINs could be treated in a different way. TPD responded that if products with dormant status do not have any batches on the Canadian market that are still within expiry, a rationale could be provided. CGPA added that there are also cases where products are approved but not marketed. Further discussions can be held at the July 6, 2021 CGPA/Bureau of Pharmaceutical Sciences, TPD meeting.

CGPA indicated that the requirement for companies to submit confirmatory testing results as part of the submission process has a high workload. TPD responded that it is important to note that the different deadlines in the October 2019 letter and subsequent extensions apply to confirmatory testing for marketed drugs and those timelines are not extended to submissions under review. There is a need to show if safety, efficacy and quality concerns have been addressed before Health Canada can issue a Notice of Compliance (NOC). TPD indicated that if sponsors cannot respond to a Notice of Non-compliance (NON) Clarifax within the 90-day deadline due to confirmatory testing, they can ask the Regulatory Project Manager for an extension.

Risk Management Plans (RMPs)

CGPA indicated that generic manufacturers are required to discuss the requirements of the RMP with Health Canada on a case-by-case basis. The association noted that it deals with a large portfolio of products and therefore this is burdensome. Bruce Wozny, Policy Officer, and David Duguay, Scientific Manager, Marketed Health Products Directorate (MHPD) addressed this item. MHPD acknowledged that it is important that manufacturers of biosimilars and generics have access to the information in the innovator RMP (e.g. relating to additional measures) to help them plan submissions. Generic sponsors are encouraged to continue to contact Health Canada directly to confirm the details when planning submissions.

CGPA requested information as to the value of continuing the generic RMP with the same elements of the originator's RMP after several years of collecting and evaluating data. MHPD responded that if there are additional risk minimization measures in place for the innovator product, then these measures will also be required for generics to ensure that the benefits outweigh the risks. At the time of a generic coming to market, there may be a need for additional pharmacovigilance activities such as assessing long-term safety for vulnerable populations. The considerations for generic RMP products in Canada are aligned with international practices with regard to additional pharmacovigilance and risk minimization measures. CGPA indicated that any additional risk minimization measures are reflected in a sponsor's calculation as to whether to proceed with a product. MHPD noted that the inclusion of a standard paragraph about the RMP in the Summary Basis of Decision for the innovator product usually means that there are no additional risk minimization measures.

CGPA suggested that Health Canada add more details about the brand's RMP into the Summary Basis of Decision so that it can make decisions in a more informed manner. Laura Johnson, Manager, External Transparency Unit, Office of Planning, Performance and Review Services, TPD addressed this item. TPD thanked CGPA for suggesting that more details about RMPs be added to the Summary Basis of Decision and noted that it would take this into consideration moving forward.

Update on Health Canada's transparency initiatives

Public Release of Clinical Information (PRCI)

CGPA thanked Health Canada for extending the deadline for the clinical transparency requirement for the Abbreviated New Drug Submissions (ANDSs) and Supplement to Abbreviated New Drug Submission (SANDSs) to 2023. CGPA also thanked Health Canada for providing support to its members throughout the process, which is new for most of the generic companies. CGPA noted that it is an intensive process which requires a lot of resources, especially for the anonymization of Confidential Business Information (CBI). CGPA asked whether Health Canada is tracking who is making requests for disclosure of Confidential Business Information and how this information is being used.

Melissa Jean, Scientific Reviewer, Resource Management and Operations Directorate (RMOD) thanked CGPA for providing this feedback. The PRCI initiative was launched in March 2019 and to date Health Canada has made public over 3.4 million pages of clinical information associated with over 150 drug and device submissions/applications. RMOD has also published guidance documents to provide more clarifications. RMOD receives some information as to who has made requests for confidential business information but cannot disclose personal information as to who made the request. A PRCI annual report was published in 2020 which discloses the general category of who made the request. This report is available by request by contacting Melissa Jean at (Melissa.Jean@hc-sc.gc.ca). Update: The PRCI portal is available on the Health Canada website.

Generic Submissions Under Review (GSUR) List

Health Canada hosted a consultation which requested potential impacts on organizations if additional information were to be added to the GSUR list. This included questions about adding company names to the list. Laura Johnson, Manager, External Transparency Unit, Office of Planning, Performance and Review Services, TPD addressed this item. Responses received were varied, with regards to the potential benefits of having this information available as well as concerns about possible harmful effects. While a clear path forward was not identified, the consultation results will inform ongoing projects related to transparency.

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, a sponsor can request an extension to pause the review clock under a specific set of circumstances, giving the sponsor additional time to respond to a Clarification Request. The following Health Canada website link has more information: Guidance Document: Management of Drug Submissions and Applications.

CGPA was provided with metrics for Pause the Clock Drugs for Human Use (April 1, 2020 to March 31, 2021). On average, there were 67 submissions for TPD, BRDD and Natural and Non-prescription Health Products Directorate (NNHPD) and the average pause time per submission was 23 days. The pauses occurred at all stages in review. 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 with other directorates. All Pause the Clock requests have been granted in order to provide more time for sponsors to respond to requests. BRDD indicated that if a sponsor receives a Clarifax and the review clock is paused, other review streams would continue during the pause. CGPA member companies should reach out to the Regulatory Project Manager of the file if they are planning to seek a pause.

TPD performance review

Timing of the issuance of Notices of Deficiency (NODs)

CGPA indicated that receiving a NOD towards the end of the review cycle can have a significant impact on an organization, especially when drugs have multiple suppliers. Christine Leroux, Office of Planning, Performance and Review Services, TPD addressed this item. TPD noted that over the last year, it processed an additional 95 submissions and still maintained performance targets. TPD added that it is only when the reviewer analyzes the details of the submission that it becomes clear as to whether appropriate data is included. TPD emphasized that it does not take any negative decisions lightly. If a negative decision is made, the issues are identified are substantiated.

Cost recovery Product Monograph (PM) updates

Trish Larwill, Resource Management and Operations Directorate (RMOD), addressed this item. RMOD indicated that there are plans for a consultation with stakeholders in Fall 2021. CGPA expressed concern relating to Product Monograph updates for generic products and noted that many of its Supplement to Abbreviated New Drug Submission (SANDS) labelling only generics are being reclassified as labelling-only at a higher cost and longer performance target. CGPA indicated that it would participate in the stakeholder engagement.

Submission status updates

CGPA indicated that before the COVID-19 pandemic, its members received more submission status updates from Health Canada and requested that more information be provided. TPD responded that it has made significant investments in staffing in order to deal with the increased workload due to the COVID-19 pandemic. This may help TPD be more proactive with submission status updates. TPD added that there may be periods of uncertainty where things are evolving and certain information cannot be shared. CGPA noted that it would be helpful to know if the final decision has not been made yet.

Bioequivalence clinical trials review timelines

Carole Légaré, Director of the Office of Clinical Trials, TPD presented this item. Bioequivalence (BE) studies are typically used to establish evidence of a high degree of similarity in the bioavailabilities (BA) of two pharmaceutical products (e.g. a generic and innovator) and are used as a basis for market authorization applications for generic drugs. All Clinical Trial Applications (CTA) are subject to a 30-day default review period. In 2001, Health Canada introduced a 7-day expedited review process with the goal of reducing administrative burdens and attracting more clinical trials to Canada. Note that the 7-day review period is an administrative target only. The number of Phase I Bioequivalence CTAs has decreased rapidly over the last five to ten years. TPD added that a growing proportion of BE/BA trial applications are for products that are not intended for the Canadian market. As a result, it is increasingly difficult to justify prioritizing the review of these applications over those that offer therapeutic options for the unmet medical needs of Canadians. Health Canada is currently reviewing overall timelines across clinical trial health product lines as part of its Clinical Trial Modernization.

CGPA indicated that the 7-day review timeline for industry has been a distinct advantage when companies need to develop bioequivalence data to respond to a Notice of Deficiency (NOD) or a Notice of Non-Compliance (NON). Sponsors have 90 days to respond to a NOD or a NON and CGPA expressed concern that they may have to request extensions if the bioequivalence timeline is extended. CGPA indicated that, historically, the 7-day target has been a good incentive for clinical trials to be attracted to Canada. TPD is waiting to see what comments are provided by stakeholders during the consultation before making changes to review timelines.

Roundtable

Clinical trial modernization consultation

Rita Beregszaszy, Director, Bureau of Policy, Science and International Programs, TPD presented this item. The Clinical Trials Modernization: Consultation Paper was posted on May 20, 2021 for a 45-day consultation. In addition, TPD is holding a series of targeted stakeholder sessions through Spring and Summer 2021. A specific session for the drug industry is expected to take place in June 2021.

Post-Notice of Compliance (post-NOC) Changes Quality Guidance Document

Rita Beregszaszy, Director, Bureau of Policy, Science and International Programs, TPD provided an update. This guidance aims to facilitate post-approval changes for drugs in a more predictable way across a product's lifecycle. There will be a more targeted discussion at the July 6, 2021 CGPA/Bureau of Pharmaceutical Sciences, TPD meeting. Update: A consultation for the Draft revised guidance documents on Post-Notice of Compliance (NOC) Changes – Quality document will be open from August 6 to November 4, 2021.

Closing remarks and adjournment

Dr. John Patrick Stewart, TPD, indicated that Health Canada appreciates hearing CGPA's perspective on the issues and the impact on its members. This helps inform Health Canada's way forward. Duane Terrill, CGPA Co-chair, thanked Health Canada for hosting the meeting and indicated that it was an informative and helpful meeting.

Meeting adjourned at 3:50 p.m.

Next meeting

The Fall 2021 meeting has been postponed until Spring 2022 due to the federal election period.

Signed by:
John Patrick Stewart
Director General
Therapeutic Products Directorate