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Final Record of Decisions - October 24, 2014, Meeting with Canada's Research-Based Pharmaceutical Companies (Rx&D)

Health Canada - Health Products and Food Branch (HPFB) Bilateral Meeting Program

1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario

October 24, 2014 (1:00 p.m. to 3:40 p.m.)

Rx&D Participants

Health Canada Participants

Health Canada Observers

1. Welcome and Opening Remarks

Barbara J. Sabourin, Director General of the Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB) welcomed everyone to the meeting, and a roundtable of introductions followed. John Patrick Stewart, Executive Medical Director (TPD), mentioned that there are a number of very active issues in the Directorate. TPD is looking at using resources in the best possible way in order to maximize efficiency. The Directorate is very active on the international front as will be discussed later in the meeting. Travel and conference attendance is a challenge for HPFB staff due to fiscal restraints.

Mark Beaudet, Rx&D Co-Chair, indicated that Rx&D appreciates everyone taking the time to participate in the bilateral meeting.

2. Review of the Agenda

No changes to the agenda.

3. Approval of Meeting Notes of May 2, 2014 / Previous Action Items

The May 2, 2014 Record of Decisions was approved.

All action items from the May 2, 2014 meeting have been completed.

4. TPD Performance Reporting / Pipeline

Hugh Scheuerman, Manager, Performance Reporting and Review Services, Office of Planning, Performance and Review Services (OPPRS), TPD and Anne Bowes, Director, Office of Submission and Intellectual Property, TPD provided a joint presentation. Hugh Scheuerman reported on updated performance metrics for TPD and revisions to drug pipeline data collection and reporting. In the future, TPD will be sending pipeline templates to individual companies rather than to Rx&D. For any questions relating to the pipeline template, please contact Hugh Scheuerman.

Anne Bowes presented on a TPD request to companies to cancel their Drug Identification Numbers (DINs) that will not be marketed. She emphasized that this only applies to DINs that have approval but where the company has no intention of commercializing.

As of 2015, the Office of Submission and Intellectual Property (OSIP), TPD is planning to include products with a "DIN Assigned" status as a separate product list in the Annual Drug Notification Form to encourage sponsors to cancel the DINs they do not intend to market in Canada. This would allow for the status of drug products in the Drug Product Database (DPD) to be more up to date and would also be beneficial for sponsors as they would have a complete list of all their DINs in one report on an annual basis.

With the implementation of this change, OSIP would stop the DIN Assigned Project where every 2 years, manufacturers of products with DIN Assigned status were asked to clarify the status of their products on the Canadian market.

Action: At the request of Keith McIntosh, Rx&D, Anne Bowes, OSIP, is to provide a letter to Rx&D about encouraging companies to cancel DINs that will not be marketed.
Update: Action item complete.  A letter from Anne Bowes was sent to DIN owners in November 2014.

5. Guidances and Policies

Rx&D requested an update on guidances and policies as the association is interested in understanding Health Canada's plan for issuing these documents.

Alexandra Bray, Senior Policy Analyst, Bureau of Policy, Science and International Programs, TPD indicated that TPD and Biologics and Genetic Therapies Directorate jointly developed the Draft Guidance for Industry: Drug Submissions Relying on Third-Party Data [Literature and Market Experience]. A stakeholder consultation was launched for a 90 day period from June 13th to September 13th, 2014. The Working Group is currently addressing the external comments and revising the guidance accordingly. Discussions with the Australian Therapeutic Goods Administration (TGA) will inform the finalisation of the Guidance. The Guidance is expected to be completed by summer 2015. Rx&D had raised some concerns with the guideline during the consultation period, including the data requirement. Rx&D suggested that Health Canada consider conducting consultations on the intent and scope prior to finalizing the document.

6. Changes to the Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions

Marilena Bassi, Director, Office of Planning, Performance and Review Services, TPD presented an overview of the Food and Drug Act Liaison Office's new role in the reconsideration process and related changes within the Health Products and Food Branch.

Action: At the request of Keith McIntosh of Rx&D, a follow-up meeting is to be organized with the Food and Drugs Act Liaison Office.

Other Health Canada Guidance Documents

Mandy Collier, Bureau of Policy, Science and International Programs thanked Rx&D for their comments on the Plain Language Labelling Questions and Answers Consultation, which provided information to industry on how the branch intends to implement the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use). Comments will be taken into consideration in the finalization of the Q&A document, which is anticipated to be web-posted in early 2015. Rx&D expressed concerns regarding the new requirements for mock-ups in both official languages and at the time of filing. It was agreed that a separate meeting would be set up to discuss.

Also under the Plain Language Labelling initiative, stakeholders will have the opportunity to comment on proposed revisions to the Product Monograph Guidance, Part I: Health Professional Information and Part II: Scientific Information, before the end of 2014.

Action: Rx&D (Sandra Usik of Eli Lilly) requested an update on the Draft Guidance Document: Quality (Chemistry and Manufacturing): New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) from the Bureau of Pharmaceutical Sciences, TPD. Update: Action item complete.

Action: The Bureau of Policy, Science and International Programs to follow up with Rx&D to discuss the new plain language labelling requirements for mock-ups in both official languages. Update: Action item complete.

7. Consumer Health Products Framework

Adam Gibson, Director General, Natural and Non-prescription Health Products Directorate (NNHPD) presented the latest information on the department's work on the consumer health products framework. In November 2014, Health Canada will launch consultations on the consumer health products framework, including the separation of lower-risk products from the framework for prescription drugs. NNHPD is interested in hearing from Rx&D on perspectives. Adam Gibson invited Rx&D to comment on the framework.

The CHP Framework Consultation document can be found on the Health Canada website.

8. Key International Initiatives

Rx&D appreciated the Summary Table of Key International Initiatives introduced as a Roundtable item at the May 2014 bilateral meeting and requested that updates to the table be provided at future bilateral meetings. The association would like to better understand Health Canada's overall priorities and approach as it works with international organizations.

Mike Ward, Manager, International Programs Division (IPD), Bureau of Policy, Science and International Programs provided Rx&D with an updated Summary Table of Key Initiatives which included next steps for the International Conference on Harmonization (ICH), the Regulatory Cooperation Council (RCC) with the US, the Regulatory Cooperation Initiative (RCI) with Australia, and the Pan-American Network for Drug Regulatory Harmonization (PANDRH), along with various other international initiatives that involve Health Canada participation.

Rx&D requested that a smaller meeting be organized with the Bureau of Policy, Science and International Programs (BPSIP), TPD to enable them to ask more detailed questions about key international initiatives. Patrice Lemyre, Director of BPSIP, TPD indicated that he would look into the best format for the meeting and that Rx&D should contact him in the second half of November 2014.

Action: Barbara J. Sabourin, Director General, TPD, requested that Rx&D keep Health Canada in the loop about any contact the association has with the FDA.

Action: Rx&D to contact Patrice Lemyre, Director of BPSIP, TPD regarding the best format for the smaller meeting the association requested about key international initiatives.

9. Modifications to the Pristine Product Monograph Process

Kristen Zorn, Senior Regulatory Project Manager, Regulatory Project Management Division (RPMD), Office of Planning Performance and Review Services, TPD introduced this item. Effective December 1st, 2014, TPD will be changing the process for final approved/pristine Product Monographs (PMs).

In the current process, pristine PMs are requested after the completion of all review streams and must be received by TPD prior to the issuance of the No Objection Letter (NOL)/Notice of Compliance (NOC). Moving forward, TPD will no longer be waiting to receive the pristine PM prior to the issuance of the NOL/NOC. TPD will be using the last reviewed non-annotated PM as the approved PM. Sponsors will be notified via email of the PM version that is considered to be the final approved version for posting on Health Canada's Drug Product Database (DPD). The date on the first and last page of the PM will be revised to match the date of the email notification.

Please note that pristine PMs will no longer need to be submitted via email. Additionally, a PM certification form will no longer be required.

For eCTD submissions: In order to complete the submission electronically, a pristine PM sequence will still be required, and should be submitted as soon as possible following the email notification.

10. Update on Project Planning and Review Progress for Sponsors

Kristen Zorn, Senior Regulatory Project Manager, Regulatory Project Management Division (RPMD), Office of Planning Performance and Review Services (OPPRS) indicated that TPD would like to begin using the Submission Status Update Form as a means of communicating a submission's status to sponsors. Much of the information contained within the form is currently being shared with industry, but this new template will help to ensure that updates are provided in a consistent and predictable manner. The initial feedback, provided following the Kickoff Meeting, is intended to be a baseline plan. The intent of the Submission Status Update Form is to flag upcoming Clarifaxes and any other issues, if possible. Rx&D was provided with a copy of the template for the Kickoff/Progress Meeting Sponsor Feedback form. Please send any comments about the Submission Status Update Form to Robyn Blom.

Rx&D appreciated the work that goes into the Submission Status Update Form and offered to share best practices with Health Canada. Rx&D suggested that the Regulatory Project Management Division, TPD share the template with the Biologics and Genetic Therapies Directorate (BGTD). Kristen Zorn, Regulatory Project Management Division (RPMD), TPD agreed that sharing the template with BGTD would be a good idea.

Action: Robyn Blom, Regulatory Project Management Division, Office of Planning, Performance and Review Services, TPD is to share the Submission Status Update Form template with BGTD. Update: Action item complete.

11. "Pivotal" Biostudy Requirements at Screening

Kristen Zorn, Senior Regulatory Project Manager, Regulatory Project Management Division (RPMD), Office of Planning Performance and Review Services, TPD provided Rx&D with examples of situations as to when a bioavailability study is considered to be pivotal at screening.

12. Update on Summary Safety Reviews

Matthew Bown, Associate Director, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate provided an update on the publication of summary safety reviews. If a potential safety issue is identified, Health Canada assesses all available information through a safety review to determine if there is a change in its benefit and safety profile. A summary of these findings is developed for all pharmaceutical and biologic safety reviews and can be found on the Health Canada website.

The sponsor will be notified 24 hours before the review is released. Summary Safety Reviews will be expanded to include natural health products and medical devices in 2015. Full safety reviews are made available upon request (redacted for personal and confidential information prior to release). The Marketed Health Products Directorate is always open to receiving feedback about this topic.

Action: Rx&D (Alison Maloney of Bayer Inc.) requested that more than 24 hours of notice be provided to sponsors before a Summary Safety Review is released in order to allow preparation of Q&As or other communications; and that any reviews of Natural Health Products be shared when completed. Matthew Bown, Marketed Health Products Directorate to look into this topic.

Action: Rx&D (Alison Maloney of Bayer Inc.) requested the opportunity for sponsors to review confidential business information. This will be flagged to the Policy, Planning and International Affairs Directorate.

13. Risk Communication Template

Matthew Bown, Associate Director, Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate indicated that a single, streamlined template has been developed to replace multiple risk communication templates. In addition to simplifying the selection of tools to use, the streamlined template offers the following benefits:

  1. Only one document per risk communication needs to be created and translated by industry and Health Canada;
  2. Health professionals and consumers receive similar/consistent information, with additional details tailored to each group;
  3. The "red box" header can be used to provide information as to the urgency of the risk communication (Alert, Important Safety Information);
  4. Enhanced dissemination of information on the web by leveraging the technology (e.g., use of collapsible headings).

Rx&D (Alison Maloney of Bayer Inc.) thanked Health Canada for the transparency and requested a consultation where the association could input to the template and other aspects.

Action: MHPD will follow-up to Rx&D's request for a consultation on the risk communication template.

14. Round Table

a) Plain Language Labelling

Keith McIntosh, Rx&D, indicated that companies will be preparing labels for the July 1, 2015 deadline and need to know Health Canada expectations.

Action: The Bureau of Policy, Science and International Programs will be following up with clarifying information relating to plain language. Update: Action item completed.

Action: TPD will provide Rx&D with a contact in the Policy, Planning and International Affairs Directorate for this topic.

b) Bilateral Meeting Documentation

Keith McIntosh, Rx&D, indicated that Rx&D needs more lead time to review documentation for bilateral meetings. Barbara J. Sabourin responded that TPD is looking at making changes to the Bilateral Meeting Program. One of these changes is that TPD will be requesting that presentations be made by associations at the bilateral meetings.

c) Tamper Resistance

Kimby Barton, Bureau of Cardiology, Allergy and Neurological Sciences indicated that a tamper resistance concept paper is being developed.

d) World Dementia Council

Kimby Barton, Bureau of Cardiology, Allergy and Neurological Sciences shared that Health Canada will be participating in the World Dementia Council meetings in November and December 2014 and in March 2015. Pharmaceutical regulators from ten countries will discuss ways of using existing laws and regulations to support dementia research.

15. Closing Remarks & Adjournment

Barbara J. Sabourin indicated that there is value in these meetings. Rx&Ds meet-and-greet with HPFB's new ADM, Anil Arora, will take place soon.

The meeting was adjourned at 3:30 PM.

16. Next Meeting

The next bilateral meeting with Rx&D will be held in Spring 2015.

Original signed by
Barbara J Sabourin
Director General
Therapeutic Products Directorate

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