Innovative Medicines Canada (IMC): Final record of decisions May 17, 2022

Health Canada, Health Products and Food Branch (HPFB)
Bilateral Meeting Program
Virtual
May 17, 2022 1:00 p.m. to 3:10 p.m.

On this page

• Participants
• Meeting minutes
• Next meeting

Participants

IMC participants

• Lama Abi Khaled, Innovative Medicines Canada (Co-Chair)
• Laura King, Novartis Pharmaceuticals Canada Inc. (Co-Chair)
• Judith Mergl, AbbVie Corporation
• Anita Hammer, Amgen Canada
• Perry Proskos, Astellas Pharma Canada
• Neerja Goyal, GlaxoSmithKline Inc.
• Christine Mossa, Ispen Biopharmaceuticals Canada
• Katherine Tsokas, Janssen Pharmaceuticals
• Sandra Wainwright, Merck Canada Inc.
• Lorella Garofalo, Pfizer Canada Inc.
• Carrie Ku, Sanofi Canada
• Michael Baranyai, Takeda Canada Inc.
• Emily Roome, Innovative Medicines Canada

Health Canada participants

• Bruce Randall, A/Director General, Pharmaceutical Drugs Directorate (PDD), Co-Chair
• Mandy Collier, A/Senior Executive Director, PDD
• Rita Beregszaszy, Bureau of Policy, Science and International Programs (BPSIP), PDD
• Marc Berthiaume, Bureau of Medical Sciences (BMS), PDD
• Alysha Croker, Office of Policy and International Collaboration (OPIC), Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
• Émile Geoffroy, Office of Planning, Performance and Review Services (OPPRS), PDD
• Andrea Hamilton, OPPRS, PDD
• Alice Hui, Bureau of Metabolism, Oncology, and Reproductive Sciences (BMORS), PDD
• Sarah Labib, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), PDD
• Shannon Laforce, Resource Management and Operations Directorate (RMOD)
• Wayne Loo, BPSIP, PDD
• Joe-Anne McKittrick, Director General's Office, PDD
• Andre Molgat, RMOD
• Vincent Punch, OPIC, BRDD
• Natasha Rastogi, BPSIP, PDD
• Andrew Raven, BPSIP, PDD
• Andrew Slot, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), PDD
• Chris Rose, Bureau of Pharmaceutical Sciences (BPS), TPD
• Jeffrey Skene, BCANS, TPD
• Evelyn Soo, BGIVD, TPD
• David Southam, BRDD
• Emma Spreekmeester, BPS, TPD
• Mona Walsh, Regulatory Project Management Division (RPMD), PDD
• Donna Watt, OPPRS, TPD
• Mayssa Witiluk, RPMD, PDD
• Kristen Zorn, BPSIP, PDD

Observer

• Mohammed Faisaluddin, RPMD, PDD

Meeting minutes

Welcome and opening remarks

Bruce Randall, A/Director General of the new Pharmaceutical Drugs Directorate (PDD), welcomed everyone to the virtual bilateral meeting between Innovative Medicines Canada (IMC) and Health Canada. The Therapeutic Products Directorate has been renamed the Pharmaceutical Drugs Directorate as of May 2, 2022. This is to reflect that the Medical Devices Directorate is now its own directorate and therefore the focus of PDD is now on pharmaceutical products. Bruce Randall thanked attendees for their flexibility with the continuing virtual format and for taking the time to participate in the meeting.

There have been some changes in senior management since the last bilateral meeting on May 12, 2021. Dr. John Patrick Stewart recently retired from his role as Director General of the Pharmaceutical Drugs Directorate (PDD) on May 10, 2022. As of June 1, 2022, Melissa Hunt will assume the role of Acting Director General until a permanent replacement is identified. Nancy Hamzawi has been appointed as Assistant Deputy Minister of the Health Products and Food Branch (HPFB) following the retirement of Pierre Sabourin in December 2021.

COVID-19 has continued to be a priority for Health Canada. PDD thanked IMC member companies for supporting the efforts to maintain the health and safety of Canadians during the pandemic and for showing flexibility when working with Health Canada to advance product approvals. Health Canada has brought forward transition regulations that has allowed many of the flexibilities that were implemented for COVID-19 health products to remain in place on a longer-term basis.

Lama Abi Khaled and Laura King, IMC co-chairs, thanked the Health Canada team for continuing to engage with industry through these bilateral meetings. Throughout the pandemic, there has been great collaboration and engagement with Health Canada, and IMC will strive to continue that moving forward. IMC indicated that while the virtual meetings have been a great way of communicating during the pandemic and the productivity has never slowed down, the association hopes to return to meeting in-person.

Review of the agenda

There were no changes to the agenda.

Approval of meeting notes of May 12, 2021 / Previous action items

The action items from the previous bilateral meeting on May 12, 2021 were completed. The Record of Decisions (RoD) was approved.

Access consortium strategic plan 2021-24

IMC congratulated Health Canada for all of the progress that has been made so far with the Access Consortium, especially during a global pandemic. IMC is interested in helping to build a pathway that brings benefits to all stakeholders and is partnering with trade associations in Access countries. IMC is preparing to conduct a follow up survey to the one that it conducted in Canada last year. The goal is to gather greater industry experience with Access and further understand what motivates companies to participate and what barriers prevent companies from participating. IMC is willing to share the results with Health Canada. IMC indicated that Health Canada can send any specific questions that they would like to include in the survey to Lama Abi Khaled at IMC.

IMC indicated that it is interested in obtaining updated metrics on Access submissions such as how many have been done to date and how many are new active substances, generics and new indications. Jeffrey Skene, Director, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), PDD addressed this item. PDD provided IMC with some recent examples of Access Consortium submissions for the 2021 calendar year. In terms of Access approvals, the new active substance group was equally split between new indications and new active substances.

Action: Jeffrey Skene, BCANS, PDD, indicated that he would provide IMC with more metrics for the Access program.

Response: Access program metrics are to be provided at the November 24, 2022 bilateral meeting.

PDD indicated that Health Canada is working with the Access and Health Technology Assessment (HTA) partners to establish the best approach for sharing review reports. Confidentiality and legal issues are the biggest barrier for Health Canada sharing the clinical review reports with the HTAs. A short-term answer is to ask the sponsors if they can facilitate the sharing of the foreign clinical review reports with the HTAs. PDD noted that the sharing of review reports entails legalities and a fair bit of work with going though CDAs. PDD has had experience with four aligned reviews where this process is improving.

IMC asked when Health Canada is likely to realize the benefits from work sharing (e.g. a reduction in the resources required for reviews). PDD indicated that every Access work share improves the efficiency of the process as more review teams become involved in the process. Confidence in each other's reviews is a key consideration to any international work sharing approach. The more experience that Health Canada gains, the more confident it is working with its partners. This is helpful for the overall benefit of the program as the group works towards harmonization of approaches and understanding of each other's decisions. PDD indicated that having the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom join Access has been an advantage for everyone. Currently the MHRA is involved in their first two Access submissions. PDD also noted that the MHRA have been very collaborative. PDD is seeing the benefits with lessons learned, and MHRA is an active partner in providing valuable input and ideas during Access Consortium discussions.

PDD indicated that all five Access partners have begun working on a consolidated priority review pathway. Discussions regarding criteria have already begun and will be followed by processes and timelines. It is a priority for the Access Consortium: New Active Substance Work Sharing Initiative (NASWSI) to move forward with this project. IMC asked whether Health Canada would consider reaching out to industry to consult on what this type of pathway could look like. PDD responded that it is not there yet, however this question would be brought back to the consortium as a point to consider. PDD noted that if it has any specific questions that it would like to add to the survey, it will send them directly to Lama Abi Khaled at IMC by June 4-5, 2022 and that PDD would be following up offline.

Action: Jeffrey Skene, BCANS, PDD indicated that this could be taken back to the Access group as an option to consider.

Response: Access partners will be seeking input from industry on options for a harmonized priority review pathway.

Health Canada / Health Technology Assessment (HTA) aligned reviews

Emile Geoffroy, Manager, Planning, Performance and Stakeholder Engagement Division, Office of Planning, Performance and Review Services, PDD, addressed this item. The HTA-Health Canada Aligned Review pathways is a joint initiative between Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), and L'Institut national d'excellence en santé et en services sociaux (INESSS). PDD indicated that there has been good participation in the initiative from both large and small companies. For aligned reviews, sponsors can choose to provide consent for information sharing between Health Canada and the HTAs, while also filing on a pre-NOC basis with the HTAs. One of the goals of the initiative is to reduce the time interval between the issuance of a Notice of Compliance (NOC) and the HTA recommendation.

The metrics for aligned reviews so far are showing a significant reduction in the time from Notice of Compliance (NOC) to HTA recommendation. IMC asked if there is a difference in the lag time from NOC to HTA recommendation when sponsors opt in to share information versus not sharing information. PDD indicated that a 2020 analysis showed that, on average, there were 51 days from NOC to HTA recommendation by CADTH for a pre-NOC aligned review with information sharing consent versus an average of 136 days without consent. This represents more than a two-month difference on average. For pre-NOC non-aligned reviews, there is an average of 300 days from NOC to HTA recommendation by CADTH.

IMC asked if there are any milestones for sharing information. PDD indicated that at the beginning of the review, Health Canada shares with HTAs the proposed Product Monograph, the consent letter and meeting minutes that are redacted to only include clinical information. Later in the review, Health Canada shares revisions made to the Product Monograph and final clinical review reports. IMC asked whether the HTAs need all of the copies of the clinical Clarifaxes sent to them separately by the companies or just the key ones that affect the Product Monograph and the dosing that Health Canada is going to approve. PDD noted that their focus and prioritization is on the Indications and the Dosage and Administration sections. PDD suggested that IMC contact the HTAs directly as it pertains to their submission requirements. IMC asked whether any internal Health Canada prioritization is done for priority review products that are being filed pre-NOC and are going to CADTH. PDD indicated that with aligned reviews it is built into Health Canada's process to try to finalize the indication sooner, where possible. IMC indicated it would provide feedback to Health Canada regarding HTA Aligned Reviews.

IMC indicated that its members have some hesitancy to opt into a pre-NOC aligned review pathway. The association indicated that the scope of the sharing between Health Canada and the HTAs is a significant concern, especially if the dossier contains Chemistry, Manufacturing and Controls (CMC) information. Health Canada assured IMC that it does not share CMC information with HTAs. IMC noted that due to the broad language of the waiver, this is still a concern. PDD indicated that the consent letter template has not been changed as participation in the HTA alignment pathway continues to be strong. PDD noted that PDD are in discussions with the HTAs on developing some frequently asked questions (FAQs) on aligned reviews.

IMC shared that another barrier to participating in aligned reviews could be that industry does not see a difference in the timeline. IMC suggested that if more statistics could be shared, it might convince industry that the process is worthwhile, especially if there is a significant difference in timelines. PDD has heard feedback that it may accelerate the HTA decision but perhaps not the reimbursement decision which is the goal for a company.

Action: Emile Geoffroy, Office of Planning, Performance and Review Services, PDD to share statistics with IMC regarding NOC to HTA recommendation dates in advance of the November 2022 bilateral meeting.

Action completed via written response to AIS #6 for Nov 2022 IMC-PDD bilateral meeting.

PDD noted that it is interested in increasing the proportion of priority review, NOC-c and COVID-19 submissions that opt into an aligned review (currently only 8% of these submissions opt into aligned reviews). PDD asked IMC for feedback as to any potential barriers its members might have regarding opting in to aligned reviews, particularly for that category of submissions. PDD asked IMC whether these types of submissions are not being pursued with the HTAs at all or whether they are submitted at a later date. The idea is that it would be an advantage to get high priority submissions into the queue with the HTAs via an aligned review so as to obtain an earlier HTA recommendation. As a result, submissions could go into the pan-Canadian Pharmaceutical Alliance (pCPA) queue sooner which could result in an earlier pCPA decision.

IMC indicated that if its members know that their economic models may have to be adjusted at the last minute, they may be hesitant to participate in the aligned review pathway. Also, the economic models may not be available six months earlier. IMC noted that COVID-19 products may not be going through the aligned pathway as their purchasing is not done through the usual process. The association indicated that it often waits until it has more data after the drug approval so as to improve the chances that it will receive a positive reimbursement decision from CADTH or INESSS. IMC noted that Health Canada and sponsors are working hard to improve access timelines but expressed concern about the timelines when a submission gets to the pan-Canadian Pharmaceutical Alliance (pCPA). Health Canada has significantly improved its process and hopes that this will lead to quicker decisions and, more importantly, faster patient access to products.

Real world evidence (RWE) for regulatory decision making

IMC noted that RWE was launched as part of the R2D2 initiative and requested an update regarding PDD's experience to date on how submissions containing non-safety-related RWE are being used to inform regulatory decision-making. Andrew Raven, Manager of Biostatistics, Epidemiology, and Pharmacometrics, Bureau of Policy, Science and International Programs (BPSIP), PDD addressed this item. Both PDD and the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) have experience with pre-market drug submissions that have included RWE to inform non-safety related decision-making. Cases where non-safety related RWE is submitted do not occur very often. At PDD, these submissions are either related to rare diseases (especially for pediatrics) or where conventional clinical studies are not feasible or where there is an unmet medical need. PDD noted that the collection of RWE always starts post-market because products need to be on the market before the data can be collected. BRDD has received multiple submissions for vaccines relying on RWE.

Although MHPD leads the RWE work for the Branch, PDD initiated the development and implementation of an internal pre-market RWE Inventory for PDD and BRDD to help inform future guidance. PDD launched a RWE Template for clinical reviewers to complete with a Standard Operating Procedures (SOP) document in order to capture information on recent pre-market drug submissions where RWE was used in drug submissions. PDD clarified that the SOP guides reviewers on how to fill out the template and is not designed to guide reviewers on how to review RWE data.

Health Canada has published a Notice Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making and an accompanying document Elements of RWD and RWE Quality throughout the Prescription Drug Product Life Cycle. PDD has provided tailored advice to drug sponsors regarding the specifics of their RWE at pre-submission meetings. IMC noted that any information regarding RWE that Health Canada could share with industry would be appreciated. This would help to ensure that the quality of the RWE data that industry is providing through submissions meets Health Canada's expectations and is also aligned with other regulators.

PDD suggested that instead of asking how to use RWE, a better question would be to think about whether there is an evidence gap in a drug submission and what evidence would be best to use. PDD indicated that prospectively designed data is generally designed to be more robust against bias. IMC noted that companies are starting to do more prospective planning and are also to trying look at existing databases to address gaps in data knowledge. It is through 'use cases' that Health Canada and industry are going to learn how RWE can be utilized and where the challenges are.

Health Canada has no immediate plans for developing a RWE guidance as it is still at the information gathering stage. PDD indicated that Health Canada has internal working groups on RWE. PDD noted that RWE often needs to be considered on a case-by-case basis. For example, with rare diseases, the patient population might be so small that conventional clinical studies are not possible but RWE can be leveraged. IMC is interested in understanding what information Health Canada looks at when it first considers that RWE might be utilized. MHPD responded that it looks at the evidence and what the ideal circumstances would be around the disease and the setting. For example, MHPD considers whether there is an unmet need, if it is a rare disease, or if a control arm can be done.

Health Canada noted that it tries to align with HTAs (CADTH and INESSS) wherever possible but the HTAs are looking for different types of RWE. PDD indicated that Health Canada is interested in whether the drug works and if it is safe and good quality, whereas HTAs compare different drugs in order to determine which is most effective and cost efficient. Health Canada does not consider cost effectiveness in its assessments. Health Canada collaborates regularly with the FDA and the European Medicines Agency (EMA) on RWE and are aligned with them in terms of how it interprets RWE in pre-market drug submissions. There are discussions with national and international partners on how best to apply RWE moving forward. Health Canada is co-chairing a regulator-only RWE session with the FDA and EMA that is expected to be held in June 2023.

Public release of clinical information (PRCI)

IMC noted that industry is very supportive of transparency and many companies have data sharing platforms where data is provided to researchers who have legitimate scientific questions. However, PRCI has imposed a substantial burden on Canadian manufacturers with respect to resources, vendor costs, and costs for anonymization tools. IMC indicated that there are still differences with respect to how manufacturers and Health Canada view anonymization. The association also expressed concern about who bears the burden of liability, especially for submissions where there are location numbers as Artificial Intelligence may make it easier to re-identify participants. IMC requested information regarding the benefits of PRCI for Canadians.

Shannon Laforce, Executive Director, Business Transformation and Informatics, Resource Management and Operations Directorate (RMOD) and Andre Molgat, Manager, Public Release of Clinical Information Team, RMOD addressed this item. PRCI provides the public with the safety and efficacy information Health Canada relies on to issue regulatory decisions on drugs and devices. The PRCI Web Portal serves as a trusted source for Canadians to receive information they need to understand therapeutic products. These regulations were enabled by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law). PRCI is an amendment to the Food and Drugs Act for Health Canada to be more transparent around drugs that are approved in Canada.

Through the process outlined in the Guidance Document on Public Release of Clinical Information, Health Canada's PRCI team has made publicly available over 6 million pages of clinical information on nearly 250 therapeutic products. Nearly 50% of the data published through PRCI has been requested by the public. This information has been viewed and downloaded thousands of times. Over the past two years, the PRCI initiative has provided timely access to high interest clinical evidence supporting COVID-19 vaccines, treatments, and diagnostic tests.

IMC asked if Health Canada honours requests from other countries for disclosure of submissions that are retrospective (for example, from 1972). RMOD indicated that it would honour the request since personal information is not required and a requestor does not need to be in Canada. If Health Canada approved a product, then the data for that product is available on request. Half of requests for release come from academic organizations.

RMOD indicated that it is not permitted to track the personal identity of an individual who downloads information from the portal as this would be a violation of the Privacy Act. However, it is able to identify whether the information is for research purposes or personal use. RMOD clarified that even if a researcher from another country downloads information from the PRCI portal, it still benefits Canadians. RMOD indicated that 50% of the research requests originate in Canada. Some of these requests are supporting research programs at Canadian universities and institutes.

Recently, RMOD has been sitting in on a Transparency Practices Working Group that is developing international guidance around anonymization using Health Canada's PRCI guidance as a framework. RMOD will continue to engage with stakeholders on this topic and will also continue to implement flexibilities where they make sense.

e-Labelling update

IMC shared the benefits of e-labelling and noted that the most significant benefit is that patients would have access to the current labelling information instead of an outdated package insert. IMC requested an update on PDD's approach and timeline for the implementation of e-labelling for prescription drug products. Rita Beregszaszy, Director of the Bureau of Policy, Science and International Programs (BPSIP), PDD addressed this item. A draft guidance document was published for consultation that took place between March 12 and May 7, 2021. Based on the volume and complexity of the stakeholder feedback received, it became clear that there is still a significant amount of policy work that needs to be done to get to the point of having another draft guidance or a final guidance.

As an interim approach, Health Canada has published a Notice to provide additional information on how the Department intends to implement electronic labels for human prescription drugs in the near future. While physical label requirements are anticipated to continue for the foreseeable future, PDD remains open to continuing the dialogue with industry on electronic labels. At the moment, there are no plans to move forward with the guidance. PDD indicated that it would be willing, upon request, to provide IMC with high level feedback regarding the comments received during the consultation.

IMC requested clarification regarding the statement in the Notice that if sponsors choose to include links on their physical labels directing end-users to electronic platforms, the information contained on such electronic platforms should be limited only to the most up-to-date approved Product Monographs and/or Risk Management Plans or other Health Canada approved documents (i.e., verbatim copies). PDD responded that the idea was to list examples but the key message is that these need to be links to verbatim Health Canada approved products. PDD indicated that it recognizes that e-labelling is important to IMC. However, PDD also needs to balance other key priorities such as agile licencing, clinical trial modernization and an extensive policy agenda.

Accelerated review of human drug submissions

IMC requested an update on the status of the draft guidance on the Accelerated Review of Human Drug Submissions. IMC indicated that it appreciated the discussion during the May 5, 2022 Health Canada session regarding the accelerated review guidance and the rolling submission. David Southam, Senior Clinical Evaluator, Auto-immune/Endocrinology, Biologic and Radiopharmaceutical Drugs Directorate (BRDD) addressed this item. BRDD noted that the revised draft guidance was completed in Spring 2022 and an external consultation on the topic may be held as early as Fall 2022. Internal discussions are being held to determine how accelerated review is going to fit best from a policy perspective into the proposed agile licensing changes. BRDD indicated that the Accelerated Review document needs to be aligned with Terms and Conditions and rolling submissions and it anticipated to be finalized in Fall 2022. BRDD indicated that a separate discussion will be held to provide IMC with an overarching presentation of the draft Guidance Document prior to broader external stakeholder consultations. IMC indicated that it is looking forward to providing feedback on the draft guidance. Denis Arsenault (Denis.Arsenault@hc-sc.gc.ca), Manager, Office of Policy and International Collaboration, BRDD is the contact for rolling submissions.

Kristen Zorn, Associate Director, Bureau of Policy, Science and International Programs, PDD addressed this portion of the item. PDD is the lead for the Terms and Conditions piece. PDD indicated that it has heard feedback on the Notice of Intent that there needs to be more detail to outline how these new authorities would be operationalized. More granularity will be available in the draft guidances when they go to Canada Gazette 1. The goal for Fall 2022 is to bring forward: a regulatory package in Canada Gazette 1 that proposes amendments to the Food and Drug Regulations related to agile licensing; a guidance on the accelerated review; a guidance on the rolling submissions; and a guidance on the Terms and Conditions.

Implementing a quality management system in the Pharmaceutical Drugs Directorate (PDD)

IMC requested an update regarding PDD's Quality Management System. IMC indicated that improvement action plans have also been a focus for the industry. Joe-Anne McKittrick, Manager, Quality Management Division, Director General's Office, addressed this item. As part of PDD's existing Internal Quality Audit Program, several audits have been conducted over the last several years. The objectives of the audits were to assess conformance to review processes and procedures, ensure the procedures are consistently interpreted and applied across review bureaus, and identify opportunities for improvement to PDD's internal processes. In response to these internal quality audits, four improvement action plans relating to the following processes have been established: pre-submission advice; Abbreviated New Drug Submission (ANDS) review for generic drugs; executive summary preparation; and new reviewer orientation.

Mayssa Witiluk, Regulatory Project Management Division, and Sarah Labib, A/Manager, Gastroenterology Division, Bureau of Gastroenterology and Viral Diseases, PDD addressed this item. PDD indicated that progress regarding the pre-submission advice improvement action plan is on hold due to COVID-19 and other priorities. The intent of the project is to reduce any delays in providing pre-submission advice. It is anticipated that the project will resume in Summer 2022. PDD noted that the review planning project is currently on hold but is expected to recommence in Fall 2022. PDD will be working to standardize practices across the review bureaus for a consistent approach. This is workload dependent as the same people who are working on this project are also involved in review processes. PDD indicated that it intends to consult and engage with stakeholders regarding both projects in the future.

Round table

Policy updates

Rita Beregszaszy, Director of the Bureau of Policy, Science and International Programs (BPSIP) and Evelyn Soo, Director, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), PDD addressed this item. IMC thanked PDD for the extensive list of policy and regulatory updates that were provided in advance of the meeting. With regards to Antimicrobial Resistance (AMR), IMC requested information on the timelines for the Pan-Canadian Action Plan and how PDD is supporting the Public Health Agency of Canada (PHAC) who is leading the initiative. PDD indicated that there is a small policy team in BGIVD supporting PHAC's AMR task force. PDD is supporting PHAC regarding two projects that were funded under Budget 2021: creating a Canadian-specific list of reserve antimicrobials and developing educational material for patients on the appropriate use of antimicrobials. IMC indicated that it would follow up with Evelyn Soo, BGIVD, PDD, to obtain more information.

Transparency of confirmatory trial information in notice of compliance with conditions – qualifying notice (NOC/c-QN)

Mayssa Witiluk, Regulatory Project Management Division (RPMD), Office of Planning Performance and Review Services, PDD presented this item. In an effort to increase the consistency and transparency of information available to Canadians, Health Canada will be better aligning the published content of its NOC/c-QN, per the Guidance Document: Notice of Compliance with Conditions (NOC/c), with other content on its website. Specifically, information related to confirmatory trials will no longer be redacted as that information is already accessible through other Health Canada transparency tools. The redaction of personal information in the address block will remain in place to protect the identity of the employees and/or third party information involved in the submission. Health Canada is planning to send a courtesy notification to sponsors and third parties involved in the filing of new drug submissions and their supplements in June 2022 to inform sponsors of these upcoming changes.

References for submissions

IMC raised the issue that, during screening, Health Canada requests that companies submit PDF copies of all of the references that are cited in a submission. Companies receive screening deficiency notices if these references are not provided. IMC's main concern is that the request by Health Canada of all copies of references is not consistent with ICH and with what was acceptable in other countries and this was resulting in delays in Canadian submissions and extra work as sponsors were having to obtain copies of additional references and provide them to Health Canada at the time of filing. ICH requires all references cited in clinical overview and then only key references in other sections with the remaining references being available upon request. IMC would like to request a separate meeting to discuss the specifics related to this topic further.

Action: PDD to look into whether IMC members could provide a link to the reference articles cited in a submission rather than PDF copies.

Response: PDD affirms the importance of having copies of literature references provided with the submission, rather than via links, to help ensure timely review of the submission. Doing so mitigates potential delays resulting from locating the literature, including that links may change and/or become broken over time and that access to certain literature may require subscriptions. This requirement is also in line with ICH guidelines that require copies of referenced documents in support of submissions to be provided with the submission (M4E_R2__Guideline.pdf (ich.org)).

Closing remarks & adjournment

Lama Abi Khaled indicated that IMC will be reaching out directly to a few individuals at Health Canada regarding some of the action items identified during the meeting. She thanked everyone for all of the effort that goes into these meetings. IMC is interested in continuing the collaboration with Health Canada so that everybody gains, especially the patients. Bruce Randall, PDD co-chair, indicated that Health Canada appreciates the engagement and the ability to exchange information and ideas with IMC members.

The meeting was adjourned at 3:10 p.m.

Next meeting

The next bilateral meeting is expected to be held in Fall 2022.

Original document signed by:

Bruce Randall
Senior Executive Director
Pharmaceutical Drugs Directorate