Final Record of Decisions - April 20, 2017, Meeting with 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
April 20, 2017
(1:00 p.m. to 4:10 p.m.)
- Ed Dybka, AstraZeneca Canada Inc.
- Keith McIntosh, Innovative Medicines Canada
- Samar Darwish, Boehringer Ingelheim (Canada) Ltd.
- Neerja Goyal, GlaxoSmithKline Inc.
- Sandra Usik, Eli Lilly Canada Inc.
- Rocelyn Del Carmen, AstraZeneca Canada Inc.
- Sandra Wainwright, Merck Canada Inc.
- Carrie Ku, Sanofi Canada
- Catherine Lau, Janssen Inc.
- Laura King, Novartis Pharmaceuticals Canada Inc.
- Lorella Garofalo, Pfizer Canada Inc.
- Loretta Del Bosco, AbbVie Corporation
- Martin Cloutier, Bristol-Myers Squibb Canada
- Wendy Arnott, Bayer Inc.
- Niten Barua, Astellas Pharma Canada Inc.
- Anita Hammer, Amgen Canada Inc.
Health Canada Participants
- Marion Law, Director General, Therapeutic Products Directorate (TPD), Co-Chair
- Marilena Bassi, Bureau of Policy, Science and International Programs (BPSIP), TPD
- Kristen Beausoleil, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)
- Marc Berthiaume, Marketed Health Products Directorate (MHPD)
- Marcin Boruk, Resource Management and Operations Directorate (RMOD)
- Léo Bouthillier, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
- Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
- Michèle Chadwick, Biologics and Genetic Therapies Directorate (BGTD)
- Mandy Collier, OPPRS, TPD
- Lucye Galand, Director General’s Office, TPD
- Émile Geoffroy, OPPRS, TPD
- Laura Johnson, OPPRS, TPD
- Tanja Kalajdzic, MHPD
- Trish Larwill, RMOD
- Rim Lejmi Mrad, MHPD
- Celia Lourenco, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
- Cathy Parker, BGTD
- Irena Pastorekova, Office of Submissions and Intellectual Property (OSIP), TPD
- Bruce Randall, Bureau of Pharmaceutical Sciences (BPS), TPD
- Kelly Robinson, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD
- Duarte Rodrigues, Natural and Non-prescription Health Products Directorate (NNHPD)
- Kathy Soltys, Bureau of Medical Sciences (BMS), TPD
- Vikesh Srivastava, RMOD
- Deryck Trehearne, RMOD
- Donna Watt, OPPRS, TPD
- Veronica Yip, BGIVD, TPD
- Laura Meaney, MHPD
- Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)
1. Welcome and opening remarks
Marion Law, Director General of the Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed everyone to the meeting. For organizational changes, Paul Glover, former Associate Deputy Minister of Health Canada is now President of the Canadian Food Inspection Agency (CFIA). On January 3, 2017, Christine Donoghue took on the role of Associate Deputy Minister. Tina Green is A/Assistant Deputy Minister of the Regulatory Operations and Regions Branch. Kathy Soltys is A/Director of TPD’s new Bureau of Medical Sciences.
Innovative Medicines Canada indicated that it has a new president, Pamela Fralick, who joined the association in January 2017. Ed Dybka, IMC Co-chair, added that as Chair of the IMC Regulatory Affairs Committee, he is aware of the importance of these bilateral meetings as IMC priorities overlap with Health Canada priorities. The association indicated that it is at a crossroads this year with changes and that the key is to work with Health Canada.
2. Review of the agenda
There were no changes to the agenda.
3. Approval of meeting notes of October 24, 2016 / previous action items
The Record of Decisions from the previous bilateral meeting on October 24, 2016 was approved. The previous action items for Summary Safety Reviews will be covered under the roundtable portion of the meeting.
4. Improving access and use of necessary therapeutic products
Michèle Chadwick, Biologics and Genetic Therapies Directorate presented on the overarching initiative of improving access and use of necessary therapeutic products whereas Deryck Trehearne, Director General, Resource Management and Operations Directorate presented the modernized cost recovery project.
An overview was provided of the work underway on the regulatory review of drugs and devices initiative whose goal is to improve access to necessary therapeutic products. This initiative is a clear government priority as part of the commitment to work with provinces and territories in the development of a new Health Accord which was outlined in the Health Minister’s Mandate Letter.
Specifically, there is a focus on key priority areas where change would yield the biggest results. One of those areas is improved access to necessary prescription medications. Budget 2017 also earmarked support for this initiative.
Key areas of focus for the Health Products and Food Branch include:
- Health care system collaboration and international engagement
- Timely access to therapeutic products
- Real-world evidence throughout the product lifecycle; and
- Modernized cost recovery and business systems
Projects under each of these areas of focus included:
- Health care system collaboration and international engagement
- Aligning regulatory and health technology assessments
- Providing early advice by Health Canada and health technology assessors
- Enhanced use of foreign reviews to encourage submission filing for products that would not otherwise be available for sale in Canada
- Sharing workload with international regulatory counterparts with regulatory colleagues such as the U.S. Food and Drug Administration (FDA) and the Therapeutic Goods Administration (TGA) in Australia
- Timely access to therapeutic products:
- Expanding priority review pathways for drugs that meet health care system needs
- Enhancing reviews of generic drugs, medical devices and biosimilars
- Improving reviews of digital health technologies
- Modernization of SAP
- Enhanced use of real-world evidence
- Using more real-world safety and effectiveness data for drugs and devices across a product’s life cycle
- Modern and flexible operations
- A robust and agile cost recovery regime
- Modernized business systems-a common submission intake system
- Sharing of data that is not considered confidential business information
Deryck Trehearne, Director General, Resource Management and Operations Directorate, in speaking of the cost recovery project, mentioned that as the last update of cost recovery fees was in 2011, Health Canada will be consulting with IMC on the topic in the near future. Health Canada user fees are out of step with the global reality. Health Canada is interested in what IMC’s top issues are relating to cost recovery and any industry trends and future dynamics.
Ed Dybka, IMC Co-chair, indicated that there is a lot of pressure on the industry relating to cost recovery. IMC understands that costs need to be recovered but the industry is interested in knowing what that would look like. The association indicated that it values predictability and that it appreciates being included in consultations. IMC added that it is at a crossroads as the industry is preparing a package where companies will come forward with proposals for new collaborations. This industry package will include substantial changes to the current system to create a new pan-Canadian framework that would: provide Canadians with timely access to new, innovative treatments; address health system sustainability for governments; provide price and market predictability for the industry; and contribute to the country’s emerging life sciences sector and, by extension, our economic growth.
Health Canada will be consulting with IMC often over the next five years about ways to improve access to therapeutic products and will circulate the project plan when it becomes available.
5. Regulatory affairs committee’s strategies and progress update
Innovative Medicines Canada presented some of the results of two of its projects - the “Time to NOC” study and the Member Survey “Impressions of Health Canada Review Process” that it had introduced at the previous bilateral meeting on October 24, 2016.
6. Electronic initiatives
IMC indicated that through the Group on Electronic Regulatory Activities (GERA), significant progress has been made on implementing numerous electronic initiatives which have resulted in adoption of paperless processes and greater use of IT systems in the submission preparation and review process. IMC added that these have translated into efficiencies for sponsors as well as for Health Canada.
Vikesh Srivastava - Associate Director, Business Informatics & Data Science, Resource Management and Operations Directorate, and Irena Pastorekova, Office of Submissions and Intellectual Property, TPD addressed this item. GERA helps to ensure the success of technical initiatives by facilitating industry’s early engagement in the development process and helping to manage “pre”-consultation activities (Proof of Concept and Industry Pilot).
The Health Products and Food Branch and GERA co-chairs are working to develop a joint HC-GERA website which will replace the current “Collaboration” space, and will serve as a platform to share information, Questions and Answers, and collect industry feedback on key technical projects.
IMC requested an update on the use of eCTD format for Clinical Trial Applications (CTAs). Health Canada indicated that as of January 1st, 2018, the following regulatory activity types must be filed in eCTD format: New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submission (ANDS), and Supplement to an Abbreviated New Drug Submission (SANDS). A notice will be posted on the Health Canada website on April 24, 2017.
Update: The notice.
Health Canada also provided updates on Clinical Trial Application (CTA) pilot activities, the implementation of the Structured Product Monograph and the Regulatory Enrolment Process.
7. Opioid action plan Health Products and Food Branch (HPFB) activities update
Léo Bouthillier, Interim Director of the Bureau of Cardiology, Allergy and Neurological Sciences, TPD and Marc Berthiaume, Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate presented this item.
An update was provided on the activities that the Health Products and Food Branch are undertaking as part of the Minister of Health’s 5-Point Action Plan on Opioid Misuse. These activities include but are not limited to:
- better informing Canadians about opioid risks by requiring that a mandatory warning sticker be applied on containers and that an information handout be provided to patients for all dispensed (prescription) opioids, and
- reducing easy access to unnecessary opioids by adding clear contraindications to approved opioids and requiring mandatory risk management plans for all opioids. The challenges for innovators and generics in this space were discussed.
For any suggestions relating to opioids, IMC was encouraged to communicate with Kirsten.Mattison@canada.ca, Director of the Controlled Substances Directorate, Healthy Environments and Consumer Safety Branch.
8. Modernizing the regulation of self-care products in Canada
Duarte Rodrigues, Bureau of Consumer Health Product Modernization, Natural and Non-prescription Health Products Directorate, presented this item. Health Canada is looking to modernize its approach to regulating self-care products. These products are available for purchase without a prescription and include cosmetics, natural health products and non-prescription drugs. A modernized approach is being proposed that would make it easier for Canadians to make informed choices about the right products for them.
Health Canada is proposing that:
- self-care products would be regulated according to risk to consumers
- self-care products making similar claims would require similar evidence; and
- the Department would have appropriate powers to address safety concerns and non-compliance
Informed by the feedback received through the fall 2016 consultation, Health Canada has refined elements of the proposal. The Natural and Non-prescription Health Products Directorate is currently undertaking a series of in-person and online consultation sessions in various cities across Canada throughout spring 2017 to seek feedback on the refined proposal.
Health Canada reiterated that the risk based approach that is being proposed is not new; it would bring consistency to self-care products by building on what is currently in place.
9. Plain Language Labelling (PLL)
IMC requested information on any further updates to the Plain Language Labelling Regulations. The association also requested a conversation about the consistency of review practices among label reviewers, and expectations regarding providing editable PDF mock-ups, expiry dating formats, and abbreviated package inserts.
Celia Lourenco, Director, and Veronica Yip, Manager, Labelling Division, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD) addressed this item. Based on the internal and external feedback that TPD has received through discussions on PLL to date, TPD has been actively engaged with other pre-market Directorates to explore solutions for greater PLL efficiencies, including how product market history and global package label designs (e.g., expiry date formats) should be taken into consideration when reviewing labelling materials.
In response to feedback received, recent changes were made to the Mock-up Labels and Packages Certification Form (published on January 9, 2017). The revised form provides sponsors with more clarity on PLL requirements, and enables sponsors to provide a rationale where flexibilities to their labelling are being sought. If the manufacturer can provide a rationale, TPD is willing to be flexible with labelling requirements.
As part of ongoing efforts to establish consistency in review approach and decisions related to PLL, a new TPD Labelling Division was created in August 2016. The creation of this new Division has encouraged sharing of best practices and sharing of information within the pre-market area in TPD, as well as with other HPFB directorates responsible for implementing PLL for prescription drugs (and soon to include non-prescription drugs). TPD will also be exploring opportunities to provide ongoing training sessions to industry on PLL best practices and provide them with feedback on how to improve their PLL submissions.
TPD indicated that it would be helpful if sponsors can provide timelines in advance, especially if a company’s design team is not in Canada. TPD recommends that sponsors use the checklist to see if anything is missing from the labels in order to minimize clarifaxes.
Veronica Yip, Bureau of Gastroenterology, Infection and Viral Diseases, TPD encouraged sponsors to contact her with any questions about Plain Language Labelling.
10. TPD Bureau of Medical Sciences
Innovative Medicines Canada requested information on the role and function of TPD’s new Bureau of Medical Sciences. Kathy Soltys, Acting Director, Bureau of Medical Sciences, TPD addressed this item. The Bureau of Medical Sciences (BMS) was created January 1, 2017. The Bureau’s mandate is to provide medical review expertise, guidance, and the Canadian medical practice context to the regulation of pharmaceutical drugs.
The submission filing process in TPD has not changed; however, once the submission is in-house, it will be reviewed by the BMS based on specific features of the submission. Interactions between BMS and Sponsors will be similar to existing interactions between the clinical review bureaux and sponsors. Clarifax interaction with sponsors (i.e. numbers and timing of clarifaxes) is anticipated to be similar to the current situation.
11. Guidances and policies update
a) Health Canada Update on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Activites
Celia Lourenco, Director, Bureau of Gastroenterology, Infection and Viral Diseases, TPD addressed this item. Health Canada will continue to engage with stakeholders in Canada during the ICH guidance development process. Guidance documents that are at the Step 2 (consultation) stage will be posted on Health Canada’s website for a consultation period with a notification sent to stakeholders once published. The Regulatory Cooperation Council initiative with the United States Food and Drug Administration will also continue to be an opportunity for stakeholders to remain aware of the progress of guidance development, and submit questions and comments on ICH guidance documents under revision or development.
As Health Canada is a standing member at ICH, technical/regulatory implementation issues will be addressed as early as possible during the guidance development process, and with input from stakeholders. A full listing of Health Canada implemented ICH guidelines.
b) Guidances and policies
There are a number of guidance documents, notices and policies in development or being updated in 2017-18:
- Updating the Guidance Document on Classification of Drugs and Medical Devices:
TPD will be updating this document to reflect the changes to the Food and Drugs Act device definition brought in by the enactment of Bill C-17 in 2014 and also to enhance the clarity in the description of factors used by Health Canada in the classification of drugs and devices. An updated version will be posted this Summer 2017.
- Updates to the Bioequivalence Guidance Document:
The document will be updated to include highly variable drugs, which includes wording changes, definitions and removal of sections. This would replace the notice that was posted last year. Summer 2017.
- Final revised: Post-NOC changes:
Safety and Efficacy Guidance and accompanying Notice : Changes will include categorization of Post Notice of Compliance Label changes made to the Drug Facts table for non-prescription drugs, the inclusion of the management of safety changes under Bill C-17, administrative changes to provide more clarity, process changes in the filing of Level 3 label changes. Fall 2017.
- Update to the Management of Drug Submissions Guidance Document:
This Guidance document is being updated to include the current processes and will include flowcharts. Anticipated posting is Fall 2017.
- Development of questions and answers: Importation of Drugs for an Urgent Public Health Need:
Guidance document is being developed to accompany the proposed regulations that would provide access to drugs in exceptional circumstances. June 2017.
- Update to Labelling Guidance - Section for Proposed Opioid Sticker and Handout:
The Labelling Guidance will be updated to reflect any new regulatory requirements for a sticker and handout for opioid products.
- Transparency consultations:
Consultations will be taking place in Q2/3 around proposed transparency initiatives including updates to the submissions under review list and regulatory decision summaries for a subset of generics.
- Policy work to re-examine the determination of which differences in the medicinal ingredient in a generic drug in comparison to the reference product:
A Notice of Intent for consultation will be posted this Summer.
- Approaches to addressing health issues related to anti-microbial resistance:
Developing some proposed policy options which will be out for discussion in Q3.
- Cost recovery renewal:
See Derek Trehearne’s summary under Item 4.
- Policy initiatives under review reform of drugs and devices:
See Michèle Chadwick’s summary under Item 4.
- Exploration of a work sharing pilot for an NCE with the TGA under the ACSS Consortium will be taking place this year.
12. Round table
a) Summary Safety Review (SSR)
Rim Lejmi Mrad, Marketed Health Products Directorate (MHPD), addressed the action items relating to Item 8: Summary Safety Reviews from the Record of Decisions of the October 24, 2016 bilateral meeting. If IMC is interested in setting up a discussion about the timing of the posting of Summary Safety Reviews, or in providing any feedback about how the SSR process could be revised, the association should contact Alain.Musende@canada.ca, Marketed Health Products Directorate (MHPD).
b) Pre-market transparency
Laura Johnson, Office of Planning, Performance and Review Services, TPD presented this item:
- The Notice published March 29, 2017 announced that Summary Basis of Decision documents (SBDs) and Regulatory Decision Summaries (RDSs) are now posted exclusively on the Drug and Health Product Register. The individual SBD and RDS postings that were on the Health Canada website have been removed.
- A heads-up was given that a consultation will take place in the coming months on pre-market transparency. It will explore possibilities for Phase III of the RDS and Submissions Under Review (SUR) List initiatives, as well as mechanisms to increase transparency related to generics.
- An announcement was made of imminent changes to the SUR List postings. An additional column will be added to the existing lists, to indicate the month and year each submission was added. Two new lists will be added for submissions that were formerly on the SUR List but have reached a conclusion.
c) Confidential Business Information (CBI)
Deryck Trehearne, Director General of the Resource Management and Operations Directorate (RMOD) provided the update that a white paper for Confidential Business Information has been released and a technical briefing will be held with the medical device industry the week of April 24, 2017.
13. Closing remarks and adjournment
Marion Law and Ed Dybka, Co-chairs, thanked everyone for participating in the meeting.
The meeting was adjourned at 4:10 PM.
14. Next meeting
The next bilateral meeting is expected to be held in Fall 2017.
Original signed by:
Interim Senior Executive Director
Therapeutic Products Directorate
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