Record of Decisions: March 31, 2010, Consumer Health Products Canada (CHP Canada)

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Contact: Office of Business Transformation

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

Record of Decisions: Consumer Health Products Canada (CHP Canada)

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

Date: Wednesday, March 31, 2010

Start Time: 1:15 p.m.

End Time: 4:10 p.m.

Participants

CHP Canada Participants

David Skinner, CHP Canada, Co-Chair
Don Beatty, Novartis Consumer Health Canada Inc.
Todd Breedon, McNeil Consumer Healthcare
Joseph Chan, Bayer Inc.
Narinder Grewal, Wyeth Consumer Health Care Inc., a Pfizer Company
Gerry Harrington, CHP Canada
Tessa Hogerwaard, McCarthy Consultant Services
Adam Kingsley, CHP Canada
Nicki Smith, Procter & Gamble Inc.
Robert White, CHP Canada
Kristin Willemsen, CHP Canada
Robert Zielinski, GlaxoSmithKline Consumer Healthcare

Health Canada Participants

Supriya Sharma, Director General, Therapeutic Products Directorate (TPD), Co-Chair
Barbara J. Sabourin, Senior Executive Director, TPD
Jacques Bouchard, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
Bruce Boulton, BGIVD, TPD
Vianney Caron, Submission and Information Policy Division (SIPD), TPD
Lucie Desforges, Office of Consumer and Public Involvement (OCAPI), HPFB
Anita Di Franco, Bureau of Pharmaceutical Sciences (BPS), TPD
Gail Gervais, Liaison Unit, Office of Business Transformation (OBT), TPD
Adam Gibson, Director General's Office, TPD
Natasha Kuran, BGIVD, TPD
Heather L. MacDonald, Bureau of Policy, Science and International Programs (BPSIP), TPD
Satish Mallya, BPS, TPD
Étienne Ouimette, Policy, Planning and International Affairs Directorate (PPIAD), HPFB
Denise Quesnel, Liaison Unit, OBT, TPD
Sarah Skuce, HPFB-Inspectorate
Brigitte Zirger, BPSIP, TPD

Observers

Ryan Benson, OCAPI, HPFB
Edward Gertler, Strategic Policy Branch (SPB)
Christine Leroux, OBT, TPD
Rose Ngo, OBT, TPD
Joyce Pon, BPSIP, TPD

1. Welcome and Introductions

Supriya Sharma, Director General, TPD, welcomed everyone, and a roundtable of introductions followed.

Dr. Sharma mentioned that there were no major staff changes at TPD.  She announced the following changes at the Branch level:

Siddika Mithani, Associate Assistant Deputy Minister recently left the HPFB to take the position of Assistant Deputy Minister of the Oceans and Science Sector at the Department of Fisheries and Oceans.

Michael Vandergrift, Director General of PPIAD, will be leaving HPFB effective April 16th to become Director of Operations (Planning), within the Priorities and Planning Secretariat, at the Privy Council Office.

2. Review of Agenda

Approved.

3. Approval of Meeting Notes, September 16th, 2009

Approved as presented.

Review of Action Item
(Item 12c) Guidance Document
Process for removing the Drug Identification Number (DIN) products that have transitioned to Natural Products Number (NPN) from the Drug Product Database.
Vianney Caron, Project Lead, TPD E-Review, SIPD, provided the update.  He mentioned that revised database will be available on the Health Canada website next week.

4. Cost Recovery

Etienne Ouimette, Director, HPFB Cost Recovery Initiative, PPIAD, provided an update on the status of the User Fees Proposal related to human drugs and medical devices.  He mentioned that the Proposal should be tabled in both Houses before the end of April 2010, and will be subject to a 20-sitting day review period.  Following the Parliamentary review, as fees are set in regulations, any changes will require publication in the Canada Gazette.  He mentioned that since the User Fees Act came into force in 2004, six fee proposals were tabled and reviewed by Parliament.  CHP Canada will gather questions/concerns from its members.  Mr. Ouimette concluded that the increase in revenues, in combination with the retention of current public funds, would provide a stable funding platform from which to provide service and meet performance standards.

5. TPD Forward Planning (next 18 months)

Brigitte Zirger, Director, Bureau of Policy, BPSIP, responded to CHP Canada's request for TPD to identify its policy priorities by outlining the regulatory proposals and guidance's that are expected to be published for comment or finalized in the next 18 months (April 1, 2010 - September 30th, 2011).

Dr. Sharma talked about TPD's financial situation and indicated that the Directorate Management Committee (DMC) was setting priorities and looking at operational planning.  She indicated that review was TPD's core activity.

CHP Canada's top priorities are the issues with the provinces, pre-consultation on natural health products, harmonization issues, and the impact of switching a product from prescription to consumer health products status.  CHP Canada also requested that it be consulted at the issue identification stage of policy and regulatory development.

6. Guidance Development Consultation Process

Gerry Harrington, CHP Canada, mentioned that CHP Canada would like TPD to examine its current consultation process.  CHP Canada is concerned about the lack of early stakeholder engagement at the issue identification/analysis stage, stressed the need for clear project objectives in terms of health outcomes and hopes for more fulsome dialogue around the evidence being considered.

Dr. Sharma agreed in principle, but mentioned that it can sometimes be challenging in terms of how to proceed, who to invite and defining the issue.  She added that when TPD has consultations with stakeholders, especially umbrella industry associations, it expects stakeholders to get opinions/consensus of its members.  There needs to be trust from both sides.  CHP Canada was invited to contact TPD if more information was needed.

7. Notifiable Changes (NC)

Narinder Grewal, Wyeth Consumer Health Care Inc., mentioned that CHP Canada members have experienced long delays for NC submission reviews in the BPS.

Satish Mallya, Senior Scientific Advisor, BPS, TPD, explained that some changes that were previously required to be filed as NCs have now been classified as annual notifications.  In the new guidance document, changes that require the filing of NCs are those that need to be reviewed and approved prior to implementation.  A 90 day default period is inconsistent with this philosophy, so reinstating a default period is not an option at this time.  A future review of submission/notification requirements for changes is not ruled out, but this should only come after the guidance document has been in place for some time.  TPD is still working to a 90 day review target for NCs.  This has not changed.

TPD understands the challenges industry is facing with the current review performance for NCs.  Mr. Mallya elaborated on the work that BPS undertook to address the issue since December 2009.  He added that BPS was currently considering other process changes that will increase the efficiency of the review process, but could not provide additional details at this time.

While addressing the backlog of NCs, BPS has also received a large number of requests for priority NC reviews.  The Bureau cannot agree to all requests to prioritize NCs, but does consider each request carefully.  The large number of legitimate requests for priority NC review are currently using most of the core NC resources.  The additional resources that were added in December continue to focus on routine NCs.

It is understood that industry needs predictable review times for NCs.  The Bureau is working towards consistently meeting the 90 day review target for NCs and will continue to explore efficiencies and resource re-allocation until this can be accomplished.

It was suggested that the NCs return to the HPFB-Inspectorate and Sarah Skuce, Compliance Specialist, Drug Good Manufacturing Practices (GMP) Inspection Unit, mentioned that her Directorate could not take them at this time, due to the lack of inspectors.

8. Submission Performance

Nicki Smith, Procter & Gamble Inc., expressed CHP Canada's concern on the performance targets and would like BPS to present a plan to address the backlog of nonprescription medicines.  CHP Canada is also concerned about TPD's budget constraint.

Anita Di Franco, BPS, TPD, presented the BPS Workload Update.  She mentioned that BPS continues to experience heavy workload for all submission types and cannot address review performance for one type of submission without affecting the review performance of other submission types.  BPS has however made progress on improving its review performance for DINs.  In addition, thirty-three DINA submissions that were not required to be submitted and should not have been included in workload have been removed from workload.  These submissions all had target dates of July and August 2008.

While BPS is still in backlog, the gap between review pick up and target date has been narrowed.  In 2008, submissions were being picked up in excess of 6 months after the target date.  That has been decreased by at least half.  If the present review rate is maintained, BPS expects to be consistently picking up DIN applications close to their target date by June 2010.

Natasha Kuran, Nonprescription Drugs Evaluation Division (NDED), BGIVD, presented the summary of the workload experienced by NDED for both Division 1 and Division 8 drugs from January- March 2010.  The backlog is skewed by the high percentage of Post-DIN Changes (PDC) submissions which did not meet target during this time.  The PDC backlog is driven by the Paediatric Cough and Cold initiative.  Resources had been set aside to deal with an anticipated early 2009 influx of PDC submissions related to the Paediatric Cough and Cold relabelling.  These submissions were not forthcoming at that time and this has affected subsequent performance by NDED.  There has also been a recent decrease in performance on the Category IV Monograph submissions, due to resource constraints.

9. e-Review of Drug Identification Number (DIN) Applications

Vianney Caron, E-Review Project Lead, SIPD, TPD, provided clarification on the electronic submissions initiative (E-Review) at Health Canada.  He talked about the Notice to Industry on electronic submissions published in February 25, 2008; the statistics for 2008/09 for paper-based DIN applications accompanied with electronic data; Health Canada Viewing Tool (docuBridge) for the management and review of electronic submissions.  Finally, he addressed the efficiencies gained with electronic data.

Robert White, CHP Canada, mentioned that not all CHP Canada's members use the Common Technical Document (CTD) format, therefore Health Canada should advise stakeholders when such information is contained in other guidances.  Mr. Caron agreed to provide the information when docuBridge is fully operational.

10. Annex 1 to the Good Manufacturing Practices (GMP) Guidelines

CHP Canada requested feedback from the HPFB-Inspectorate on the comments they submitted on the draft Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines for Selected Category IV Monograph Drugs (GUI-0066) in November of 2009.

Kristin Willemsen, CHP Canada, raised a question on Category IV product versus Labelling Standard product risk classification.  As Sarah Skuce, Compliance Specialist, Drug GMP Inspection Unit, HPFB-Inspectorate, did not take part in the original discussion, she will talk to Johanne Veenstra, and send her comments to the Liaison Unit.

Annex 1 (formerly Annex 3) to the current edition of the Good Manufacturing Practices Guidelines- Selected Category IV Monograph Products (GUI-0066) was available for a 90 day comment period via an electronic mail-out. Unanticipated circumstances caused delays in the posting of some information online. Notification that GUI-0066 was available "for comment" was posted online on August 7, 2009.  The actual document and comment form were released upon request to the Drug GMP Inspection Unit.  Concurrent to the web notification posting and to assist in the timely dissemination of the document, Health Canada continues to proactively send emails to all Drug Establishment Licensing holders and industry associations and contacts for which we have an email address.  No major changes were made to the document currently out for comment.  The comment period ended on November 5, 2009.

The Drug GMP Committee reviewed all the comments received from stakeholders, including the comments submitted by CHP Canada, during the November 2009 meeting.  There is one outstanding issue pertaining to stability that will be addressed at the April 2009 Drug GMP Committee meeting.  Afterward, the document will be finalized, translated, and posted on Health Canada's website early this fall.  Responses to comments will also be provided once the guidance document is published.

CHP Canada's recommendation to expand the application of the Good Manufacturing Practices Guidelines - Selected Category IV Monograph Products (GUI-0066) to Labelling Standard drug products was discussed by the Drug GMP Committee.  These products are deemed higher risk products than Category IV drug products, given the fact that most of the Labelling Standard drug products are intended to be taken by mouth or to be introduced in a body cavity.  Therefore, the scope of the document will not be modified.

Action:  Sarah Skuce to send comments to the Liaison Unit.
Update:  Comments were sent directly to Kristin Willemsen, CHP Canada, on April 19, 2010.

11. Establishment Licences for Foreign Sites

Sarah Skuce, HPFB-Inspectorate, addressed this item.  The issue is that currently in Canada, fabricators, packagers/labellers and testing laboratories are subject to a 2 year inspection cycle and importers, distributers and wholesalers are subject to a 3 year inspection cycle.

As per Health Canada's "Guidance on Evidence to Demonstrate GMP Compliance of Foreign Sites" (GUI-0080), should an inspection report not be available and depending on the nature and risk profile of the products, the Inspectorate recommends submission of a corporate or consultant audit report for sites dealing with ethical drugs, over the counter Nonprescription Drugs, medical gases, and sites performing sterilization of packaging materials for products which will be aseptically filled without undergoing terminal sterilization.  The information in section 3.2.1.2, subsections C to G of the above mentioned guide should also be provided.  The conditions that the audit report should meet were provided before the meeting.

A form entitled "Good Manufacturing Practices - Audit Report Form (FRM-0211)" has been developed and may be used to ensure that all of the criteria outlined in the audit report are met. This form is available on the Inspectorate website.  The use of this template does not guarantee that a compliant rating will be assigned to a foreign site, however it will ensure a more efficient and timely review by the Inspectorate.  Additional documentation may be requested depending on the nature of the submission.

Robert Zielinski, GlaxoSmithKline Consumer Healthcare, asked Ms. Skuce whether the Inspectorate had considered accepting Quality Assurance Reports (QARs) for GMP compliance evidence for sites dealing with Category IV low risk products as Natural Health Products Directorate (NHPD) does, rather than needing an audit report conducted against the Canadian GMPs.  Ms. Skuce committed to look into the QAR requirements and see if that would be an option for Category IV products as well.

Action:  Ms. Skuce to look into the QAR's requirements.
Update:  Information was sent to CHP Canada on April 20, 2010.

12. GMP Program Review

Sarah Skuce, HPFB-Inspectorate, provided an update on the status of this project.  She mentioned that during the fall of 2009, the HPFB-Inspectorate held stakeholder consultations on its GMP Review.  This consisted of an online workbook and face-to-face consultations held in Vancouver, Edmonton, Winnipeg, Toronto, Ottawa and Montreal.  During the process, the Inspectorate was able to meet with more than 250 stakeholders and received 80 online submissions.  A consultation report is now in the approval stages and will be sent to all industry associations and drug establishment license holders in the coming weeks; it will also be posted on the Health Canada website.  In addition to the consultation report, stakeholders will receive an electronic update on the project including information on pilot projects which will commence this spring, and plans to transition the project into the implementation phase.

It will be up to the operational centres to decide on which companies will be subject to the pilot project activities.

13. Switch Times

CHP Canada would like a streamlined descheduling process where proposed switches are published within 3 months of the Drug Scheduling Status Committee (DSSC) decision and Canada Gazette Part II is published between 6 to 8 months from the date of publication of the Notice of Intent (NOI).

Heather L. MacDonald, Unit Manager, BPSIP, addressed this item.  She mentioned that the regulatory process has not changed.  This issue was discussed at previous meetings and it was then reported that TPD was working towards having the Schedule F amendments completed within 14 months of the receipt of the file from the DSSC.  Each stage of the Schedule F process is tracked and efforts are made on an ongoing basis to ensure the process is as efficient as possible.  Further streamlining of the regulatory process, such that Schedule F amendments would be completed in less than 14 months, is not realistic at this point in time given the requirements of the federal regulatory process and the Government's other regulatory priorities.

Therefore, the target is 14 months, 13 months or lower would be the exception.
Ms. MacDonald provided a flowchart of the regulatory process to amend Schedule F.

14. Status of the Labelling Guide

Bruce Boulton, Assessment Officer, BGIVD, Chair, Working Group on the Labelling Guidance, mentioned that the documents has been translated, but not available yet in Hyper Text Markup Language (HTML) format.  The translation is being verified by TPD Francophone clinical evaluators to determine its acceptability.  Following this verification, both versions will be presented to TPD DMC for approval to proceed with distribution on the Health Canada website for external comment in the Spring/Summer 2010.

Robert White, CHP Canada, suggested that TPD allows more time if the comment period falls during the summer holidays.

15. Update on activity for Product Assessment Against Criteria (PAACs)

Natasha Kuran, NDED, provided the update on this initiative.  In December 2009, Health Canada finalized and published the Transition Plan for Antiperspirants.  Since that time, Health Canada has been working on the next set of Products of the Cosmetic-Drug Interface (PCDI) categories: Antidandruff Products, Acne Treatments and Antiseptic Skin Cleansers.  Draft PAACs for these product categories and prospective transition plans (if and when applicable) are anticipated for release in Summer 2010.

The following is a list of categories Health Canada has identified for future assessment:

• Scar Treatment Products
• Skin Whiteners
• Skin Peels
• Sunscreens
• Toothpaste (anti-caries)
• Tooth Desensitizers
• Tooth Whiteners

With respect to sunscreens, Health Canada plans to conduct an exposure research survey in summer 2010.  Given the complexity of their perception and use, the survey will support decision-making on the classification of these products, including differences between usage and expectations of primary and secondary sunscreens.

Ms. Kuran mentioned that the Healthy Environments and Consumer Safety Branch is responsible for this project.

16. Roundtable

a) Look-alike/Sound-alike (LA/SA) Health Products Names

Barbara Sabourin, Senior Executive Director, mentioned that there is a responsibility to ensure that there is no confusion when naming a drug.  On the pre-market side, TPD is looking at recent risk issues associated with nonprescription drugs.  TPD will evaluate the potential phase-in of name assessments for nonprescription drugs as per the LA/SA guidance.

CHP Canada reiterated their request for an Annex for nonprescription products and natural health products be built into the planned revision of the LA/SA guidance.

17. Adjournment

Meeting adjourned at 4:10 p.m.

18. Next meeting:   

Wednesday, September 29th, 2010 (1:15 p.m.)
Holland Cross, Tower B, Boardroom 2048

Original signed by

Supriya Sharma
Director General
Therapeutic Products Directorate