Final Record of Decisions November 13, 2018 Meeting: Innovative Medicines Canada (IMC)
Health Canada - Health Products and Food Branch (HPFB)
Bilateral Meeting Program
1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario
November 13, 2018
(1:00 p.m. to 4:00 p.m.)
Jared Rhines, Akcea Therapeutics Canada, Co-chair
Keith McIntosh, Innovative Medicines Canada (IMC)
Lama Abi Khaled, IMC
Loretta Del Bosco, Abbvie Corporation
Perry Proskos, Astellas Pharma Inc.
Rocelyn DelCarmen, AstraZeneca Canada Inc.
Wendy Arnott, Bayer Inc.
Samar Darwish, Boehringer Ingelheim (Canada) Ltd.
Martin Cloutier, Bristol-Myers Squibb Canada
Sandra Usik, Eli Lilly Canada Inc.
Neeerja Goyal, GlaxoSmithKline Inc.
Catherine Lau, Janssen Inc.
Sylvie Ducharme, Knight Therapeutics Inc.
Takuhi Mirasyedi, Lundbeck Canada Inc.
Sandra Wainwright, Merck Canada Inc.
Laura King, Novartis Pharmaceuticals Canada Inc.
Larry Colero, Novo Nordisk Canada
Lorella Garofalo, Pfizer Canada Inc.
Neerja Goyal, GlaxoSmithKline Inc.
Carrie Ku, Sanofi Canada
Health Canada Participants
John Patrick Stewart, Director General, Therapeutic Products Directorate (TPD), Co-Chair
Rhonda Kropp, Director General, Marketed Health Products Directorate (MHPD), Co-Chair
Marilena Bassi, Senior Executive Director, TPD
Denis Arsenault, Office of Policy and International Collaboration, Biologics and Genetic Therapies Directorate (BGTD)
Megan Bettle, BGTD
Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
Heather Cherry, OPPRS, TPD
Mandy Collier, OPPRS, TPD
Kelly De Cecco, Marketed Health Products Directorate (MHPD)
Jennifer Dearden, MHPD
Émile Geoffroy, OPPRS, TPD
Melissa Hunt, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD
Gayatri Jayaraman, MHPD
Kelly Lehman, Bureau of Policy, Science and International Programs (BPSIP), TPD
Rim Lejmi Mrad, MHPD
Christine Leroux, OPPRS, TPD
Joseph Mikhael, Resource Management and Operations Directorate (RMOD)
Alain Musende, MHPD
Barbara Njie, Office of Policy and International Collaboration (OPIC), BGTD
Irena Pastorekova, RMOD
Sabrina Quick, MHPD
Bruce Randall, Bureau of Pharmaceutical Sciences (BPS), TPD
Kelly Robinson, BGTD
Craig Simon, BMORS, TPD
Jeffrey Skene, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
Poonam Sood, MHPD
Vernon Stringer, Bureau of Medical Sciences (BMS), TPD
Thanh Vu, MHPD (by teleconference)
Veronica Yip, BGIVD, TPD
Donna Watt, OPPRS, TPD
Bill Wilson, MHPD
Bruce Wozny, MHPD
Kristen Zorn, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
- Welcome and Opening Remarks
John Patrick Stewart, Director General of the Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed everyone to the meeting. He indicated that this will be a joint Therapeutic Products Directorate (TPD) / Marketed Health Products Directorate (MHPD) bilat to enable discussions that span the product life cycle and better integrate our pre- and post-market perspectives. He indicated that Health Canada values these bilateral meetings and he thanked IMC members for making the effort to participate face-to-face. John Patrick Stewart welcomed Rhonda Kropp of the Marketed Health Products Directorate (MHPD) as Co-chair.
An update on the following organizational changes within TPD was provided. Celia Lourenco will transition to the role of Director General of the Biologics and Genetic Therapies Directorate effective November 19, 2018. Marilena Bassi will be joining TPD’s Director General’s Office as the new Senior Executive Director, replacing Celia Lourenco. Kelly Lehman is Interim Director for the Bureau of Policy, Science and International Programs (BPSIP). Melissa Hunt has been appointed as the Director of the Bureau of Metabolism, Oncology, and Reproductive Sciences (BMORS). Evelyn Soo, who was the Associate to the Director General of BGTD, has been appointed as Director for the Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD). Rita Beregszaszy has taken on the role of Associate Director with BPSIP. The Office of Submissions and Intellectual Property (OSIP) under the direction of Anne Bowes transitioned from TPD to the Resource Management and Operations Directorate (RMOD) on October 1, 2018.
a) John Patrick Stewart, TPD Co-chair, indicated that it continues to be an active time in TPD with a high number of key ministerial and branch priorities underway, including the Health Products and Food Branch’s initiative to improve the Regulatory Review of Drugs and Devices (R2D2); the Treasury Board led Regulatory Review to modernize Health Canada regulations; the Federal Action Plan on Antimicrobial Resistance and Use; the Federal Action on Opioids; the Cannabis Act; and the Public Release of Clinical Information. John Patrick Stewart indicated that the feedback that IMC provides is appreciated and has informed Health Canada consultations.
b) Rhonda Kropp, MHPD Co-chair, indicated that the Real World Evidence initiative is making progress because of collaboration with IMC. She thanked IMC members for coming to the face-to face meeting and for their support. There have been no recent organizational updates for MHPD.
c) Jared Rhines, IMC Co-chair, indicated that IMC is happy to attend this joint bilateral meeting. The regulatory reform and R2D2 initiatives receive a lot of attention from IMC members. Jared Rhines indicated that how the IMC engages with Heath Canada is unique and the association appreciated the open and collaborative initiative. For consultations, he noted that IMC sees evidence that a lot of what it says matters and that Health Canada is taking the association’s feedback into account. Jared Rhines reinforced the concept that the earlier that IMC is engaged, the better.
Review of the Agenda
There were no changes to the agenda.
Approval of Meeting Notes of May 10, 2018 / Previous Action Items
The Record of Decisions from the previous bilateral meeting on May 10, 2017 was approved. There were no action items in the previous minutes.
TPD Performance Reporting
Christine Leroux, Supervisor, Planning and Reporting Unit, Office of Planning, Performance and Review Services (OPPRS), TPD provided a presentation on current performance metrics for TPD including key messages, a cost recovery performance summary for fiscal year 2018-19, TPD on-time performance, received vs forecasted submissions, and an IMC pipeline data summary.
Mandatory Reporting of Serious Adverse Drug Reactions (ADRs) and Medical Device Incidents (MDIs) by Hospitals
Gayatri Jayaraman, Director, Bill Wilson, Acting Manager, and Thanh Vu, Regional Coordinator, of the Marketed Health Products Safety and Effectiveness Bureau, Marketed Health Products Directorate (MHPD) presented this item. The proposed mandatory reporting regulations would amend the Food and Drug Regulations and the Medical Devices Regulations to require hospitals to provide reports of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) directly to Health Canada. This is to ensure that Health Canada receives the quantity and the quality of reports necessary to detect safety issues. Improving Health Canada’s knowledge about product safety will help Canadians to make better, more informed decisions about their medical treatment and support overall patient safety.
The draft regulations were published in Canada Gazette, Part I, and stakeholders had until August 29, 2018 to provide their feedback. After analyzing the feedback, Health Canada will consider if any changes are necessary before publishing the final regulations in Canada Gazette, Part II. IMC asked how success of this initiative will be measured. MHPD responded that success could be measured through feedback from stakeholders and by the quality and quantity of data. Awareness needs to be raised as to the value of reporting adverse reactions to Health Canada. MHPD noted that it will provide education regarding the important role providers play in reporting, how that information is used by the regulator and how we intend to share intelligence with partners.
IMC asked how Health Canada would ensure the compliance of hospitals. MHPD responded that a lot of the compliance work will be focused on promotion. IMC members expressed concerns about the potential increase in duplicate reporting with the introduction of mandatory reporting by hospitals. The association also expressed concern about the quality of reporting hospital data and the potential reduction in accuracy in the database. MHPD responded that while identifying duplicate reports is an ongoing challenge, it routinely addresses potential duplicates at various points. MHPD is looking into solutions for the issue.
IMC suggested that follow-ups would be essential. MHPD is interested in hearing from IMC as to how to leverage industry’s expertise to do follow-up. MHPD intends to connect with those who are not reporting in order to support them. IMC offered to pull together a team of pharmacovigilance experts. MHPD responded that it would appreciate the opportunity to consult with IMC members on a regular basis.
Action: Keith McIntosh, IMC, and Rhonda Kropp, MHPD, to connect to establish a team of pharmacovigilance experts.
Advertising Policy and Health Canada Position on Transfer of Values
IMC requested information on the progress of the updates to “The Distinction between Advertising and Other Activities Policy” (2005) and clarification on Health Canada’s position on Transfer of Values. Alain Musende, Manager, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate, addressed this item. The revision to the Advertising Policy involves four steps: the first step, a consultation with Advertising Preclearance Agencies has been completed; Health Canada is currently preparing for the second step, a broad external consultation with stakeholders that will take place in Winter 2019; for the third step, it is anticipated that Health Canada will host a Webinar in Spring 2019 to explain how the comments from stakeholders were addressed; and the fourth step will involve posting the revised policy on the Health Canada Web site which has a target date of Spring 2019.
Transfer of Values - Although Health Canada recognizes that Transfer of Values (ToVs) may influence prescribing practices, it has not yet determined whether activities involving ToVs would constitute advertising. MHPD intends to work in collaboration with stakeholders to review marketing practices that impact prescribing practices. Some IMC members attended the Confidential Business Information conference that was held in Summer 2018. At this conference, there was a discussion as to whether to include the distinction policy. MHPD indicated that there will be a formal discussion where IMC will be informed.
Action: Alain Musende, MHPD to share the critical path for Transfer of Values with IMC.
Proactive Monitoring of the Canadian Health Product Advertising Environment
Traditionally, Health Canada’s approach to the monitoring of health product advertising has been primarily reactive, that is, based on complaints received. However, Health Canada has now created a dedicated advertising compliance and enforcement team, which will proactively monitor the Canadian health product advertising environment, enforce the existing requirements around health product advertising, and take action where necessary. IMC was provided with a handout outlining the five steps of the New Global Approach to proactive monitoring: detection of ads involving all health products including devices; pre-screening; prioritization; compliance assessment; and compliance enforcement. Health Canada intends to launch this initiative in winter 2018 but will notify stakeholders and invite suggestions and comments prior to the launch. Health Canada will continue to address advertising complaints it receives and will post all non-compliant advertising on its website. Right now, the focus is on opioids but the intention is to focus on a broader scope in the future. Health Canada plans to develop a similar program to the “Bad Ad” program that is used by the Food and Drug Administration (FDA) in the United States.
Products with Low Demand (Overall Challenges with Reforms - SAP, Use of Foreign Decisions, Labelling, GMP requirements)
Innovative Medicines Canada indicated that it appreciates Health Canada’s commitment as outlined on the Regulatory Review of Drugs and Devices (R2D2) webpage to improve access to medications that treat rare conditions. IMC noted that many of the programs cited on the Health Canada website regarding access to products for rare diseases focus on facilitating registration (accelerated pathways, fee mitigation). IMC indicated that there are other regulatory challenges in bringing products with very small demand to Canada. Some of these barriers include the requirement for Canadian specific labels and the requirement to retain a large number of samples for testing.
Denis Arsenault and Barb Njie of the Office of Policy and International Collaboration (OPIC), Biologics and Genetic Therapies Directorate (BGTD) addressed this item. They indicated that Health Canada’s Office of Paediatric Initiatives has been transformed into a new OPIC unit created within BGTD. Product development for small populations such as paediatrics and rare diseases are of concern to the Health Products and Food Branch. New web content was posted on Health Canada’s internet site providing information about how the Canadian regulatory system applies to orphan drugs so as to encourage the further development and availability of drugs for rare diseases in Canada.
IMC indicated that there is a new Canadian Agency for Drugs & Technologies in Health (CADTH) process for drugs for rare diseases. There is also a new process within the pan-Canadian Pharmaceutical Alliance (pCPA) that targets products with small volumes. These low-volume drugs do not fit into the regular pathways. IMC sees Health Canada’s role as a guidepost for identifying products that warrant an alternative pathway. The association noted that some of its member companies have resources that others do not have.
IMC indicated that it is willing to have a discussion on this topic with other stakeholders. Health Canada responded that it is interested in being involved in early advice discussions on protocols. Health Canada has collected a lot of information on the topic through consultation and has been working on opening the door for access. It is looking at the ongoing cost of keeping small volume products on the market and is anticipating going to Canada Gazette I. Health Canada is interested in learning the views of IMC on the barriers and challenges of developing low volume products for the Canadian market. To provide further comments, IMC can contact the Office of Policy and International Collaboration, BGTD.
Innovative Medicines Canada (IMC) Update - Time to Notice of Compliance (NOC)
Neerja Goyal, IMC, presented an update on the progress of phase 3 of the “Time to Notice of Compliance (NOC)” study that was undertaken by their association. IMC shared key findings and its plans to use this approach to monitor impacts as the various Regulatory Review of Drugs and Devices (R2D2) initiatives are implemented by Health Canada.
Regulatory Enrolment Process (REP) and Electronic Common Technical Document (eCTD) Updates
Joseph Mikhael, Irena Pastorekova, Office of Submissions and Intellectual Property (OSIP), Resource Management and Operations Directorate (RMOD) and Katerina Paschakis, Business Informatics Division, RMOD presented this item. REP consists of a set of web-based templates that capture sponsor provided information in Extensible Markup Language (XML) format. REP facilitates the filing and processing of information related to a company, dossier, regulatory activity and regulatory transaction. Once fully implemented, the REP templates will replace existing Health Canada forms such as the HC 3011 form and Fee forms.
Furthermore, this process enables a move towards a common submission intake process across product lines and allows Health Canada to receive non-eCTD regulatory transactions via the Common Electronic Submission Gateway (CESG) and to automate the import of regulatory transactions into its repositories. Health Canada has currently expanded piloting the REP templates and process with pharmaceutical and biologic human drugs (Divisions 1 & 8) filed in eCTD and non-eCTD formats, and a Notice was published to solicit pilot participants on December 29, 2017. All sponsors are encouraged to take advantage of this opportunity.
Master Files - A consultation notice was published on May 7, 2018 to inform stakeholders that Health Canada was considering January 1, 2019 as the date for mandatory filing of all New Master Files in eCTD format. Health Canada did not receive sufficient feedback, therefore, the date has been moved to April 1, 2019.
Update: Final dates outlining the mandatory filling of submission in eCTD format will be provided in the updated notice.
Health Canada has commenced planning for a Medical Device Pilot implementation intended for winter 2019, a veterinary drugs REP pilot and a clinical trials pilot intended for spring 2019. RMOD encouraged IMC members to send feedback on any of the above initiatives to: email@example.com
IMC indicated that it would be an ideal opportunity for their technical publishing group to provide input.
Action: Rochelle Gordon, IMC to share contacts from the association members with Irena Pastorekova, RMOD.
Enhanced Use of Real World Evidence
IMC requested an update on the Enhanced Use of Real World Evidence project. Rhonda Kropp, Director General, Marketed Health Products Directorate (MHPD) addressed this item. Health Canada is committed to working with partners to optimize the use of real-world evidence (RWE) for decision-making at all points in the health product life cycle. By encouraging the use of RWE to support product approval and to monitor safety and effectiveness, Health Canada aims to improve the accessibility, affordability, and appropriate use of drugs and medical devices for all Canadians. To accomplish this, Health Canada will engage and consult with stakeholders, including industry, to ensure that high regulatory standards continue to be met and that RWE can be generated, used, and evaluated based on accepted guiding principles.
IMC also requested an update on the Real World Evidence (RWE) workshop that was held at the Canadian Association for Population Therapeutics (CAPT) conference on Oct 21, 2018. MHPD responded that in follow up to the CAPT meeting, Health Canada, the Canadian Agency for Drugs & Technologies in Health (CADTH) and The Institut national d’excellence en santé et en services sociaux (INESSS) are partnering to produce a single RWE Framework for Canada. This Framework will outline Health Canada’s, CADTH’s and INESSS’ intention to support the development and use of RWE in Canada, including development of guidance to support collection and submission of high quality data and evidence. An online consultation on the Framework is anticipated to be held in February 2019. MHPD will send a call out to industry in January 2019. The Framework is expected to be launched at the CADTH symposium in April 2019. There will be follow-up meeting at CAPT one year later to determine the initiative’s progress. RWE will be phased-in rather than implementing pilots. CADTH will ensure that INESSS will be kept in the loop. The intention is to do a similar joint project for medical devices in the future.
Health Canada and CADTH are also partnering to create a venue for ongoing, strategic conversations on advancing RWE use across the product life cycle, building on the momentum and energy of the CAPT workshop, among the Health Technology Assessment (HTA) organizations, Health Canada, industry, academia, payers and others. This structure is expected to launch in December 2018. The Institute of Health Economics has published a summary report of the meeting .
IMC indicated that it received a lot of positive reviews from the CAPT workshop and that its members have a high level of interest in the topic. The association is addressing RWE internally and is also working with BIOTEC. MHPD indicated that it will be relying on IMC members to provide feedback on this initiative. IMC responded that it is excited about the project and is willing to provide any expertise.
Australia Canada Singapore Switzerland (ACSS) Consortium – New Chemical Entities Work Sharing Trial Phase I
IMC requested further clarification and an update on the progress of the ACSS work sharing initiative. Craig Simon, Associate Director, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD and Kelly Robinson, Director, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB), Biologics and Genetic Therapies Directorate addressed this item. BGTD thanked all of the sponsors who participated in the pilot. Having an submission to work with is valuable and progress on the pilot is being made. The intention was to provide an optional pathway for certain submissions and was never to delay filing in Canada as this was not supposed to be a one size fits all solution. The first submission that was completed was a priority review. There are two more in review. Applications to the ACSS New Chemical Entities International Work Sharing Trial may now be filed with any two to four members of the ACSS Consortium.
Even though this is a work sharing initiative, each regulatory partner will make its own decision. Health Canada will make recommendations based on its own framework. If different decisions are made by regulators, an explanation would be provided as to why. However, the odds of being very divergent are low. IMC requested information on what happens if one country already allows for additional information during review. Health Canada responded that there is currently no provision for accepting additional information in Canada. This is taken into consideration when determining whether the file would be suitable for worksharing. The Q&As for the ACSS New Chemical Entities Work Sharing Trial Phase I are anticipated to be posted in narrative format on the Health Canada website.
Foreign Information – Serious Risk of Injury to Human Health
The new regulation requiring market authorization holders (MAH) to provide the Minister with information on risks communicated by foreign regulatory authorities within 72 hours after the MAH receives or becomes aware of the risk is coming into effect November 20, 2018. As IMC members are developing company procedures to comply with the new regulation, they requested more information about the web portal reporting tool.
Bruce Wozny, Senior Policy Officer, International and Regulatory Affairs, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate addressed this item. The draft guidance document, “Notifying Health Canada of Foreign Actions”was posted concurrently with the regulations to give Market Authorization Holders (MAHs) an opportunity to prepare for implementation. An on-line reporting form and final guidance will be posted on line in advance of the coming into force date. The final guidance will not differ significantly from the draft, except to clarify a few points raised by industry since then. The on-line form will provide a simple process for the MAH to comply with the reporting requirement. Once the entry is completed, copies will go automatically to Health Canada reviewers and to the MAH for confirmation.
The content for the new guideline and form are currently being coded on a test server and there will be a live test this week. When it goes “live”, a Notice will be sent out with a link to the page. Comments that have been received by MHPD since Canada Gazette II publication have all been addressed. The language in the guidance and form are consistent now. If IMC members have any comments, they should contact MHPD. MHPD is anticipating hosting a Webinar by the end of January 2019. There will be a check-in on the Guidance Document after a year. MHPD indicated that an updated Guidance Document, Notifying Health Canada of Foreign Actions - Guidance Document for Industry, will be posted by November 20, 2018.
a) Antimicrobial Resistance (AMR)
Jeffrey Skene, Associate Director, Bureau of Gastroenterology, Infection and Viral Diseases, TPD, welcomed everyone to Antibiotic Awareness Week (November 12-18, 2018). The message from the Minister of Health, The Honourable Ginette Petitpas Taylor, on AMR went live on November 12, 2018.
The pathogens of interest list is expected to be posted the week of November 19, 2018. The original consultation document has been updated to include feedback from stakeholders. Class labelling is almost complete and is anticipated to be finished in Winter 2019.
b) Consultation Periods
IMC indicated that there seem to be more consultation documents with 30-day consultation periods. The association noted that it is important to have robust and in-depth consultations. If consultations do not have a long enough time frame, they will be difficult to process.
c) Regulatory Review of Drugs and Devices (R2D2) Performance Metrics
Catherine Lau, IMC, indicated that she had discussed metrics to measure success with TPD and asked if metrics have been set up for the other 13 R2D2 projects. She indicated that IMC is interested in enhancing Canadians’ access to better drugs faster and requested that a couple of summary slides be provided. Megan Bettle, Biologics and Genetic Therapies Directorate (BGTD), indicated that the R2D2 team is working on developing an evaluation framework. Further information on indicators and results will be provided to IMC when available.
Closing Remarks & Adjournment
John Patrick Stewart, TPD, and Rhonda Kropp, MHPD thanked everyone and indicated that IMC’s participation and engagement is valuable.
The meeting was adjourned at 4:00 PM.
The next bilateral meeting is expected to be held in Spring 2019.
Original signed by:
Marketed Health Products Directorate
John Patrick Stewart
Therapeutic Products Directorate
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