Record of Decisions - May 16, 2012, Canadian Consumer Specialty Products Association (CCSPA)

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Contact: Office of Business Transformation

Health Canada - Health Products and Food Branch - Bilateral Meeting Program

• Record of Decisions: Canadian Consumer Specialty Products Association (CCSPA)
• Location: 1600 Scott Street, Holland Cross, Tower B, 2^nd Floor, Boardroom 2048, Ottawa, Ontario
• Date: Wednesday, May 16, 2012
• Start Time: 1:30 p.m.
• End Time: 3:30 p.m.

CCSPA Participants

Cheryl Fougere, Director of Policy, CCSPA

Heather Barker, SC Johnson and Son, Ltd.

Shan Chaudhuri, Clorox

Shannon Coombs, CCSPA

Teleconference

Stephen Chambers, Dell Tech

Teri Jenner, Dell Tech

Mike Gilbrook, SC Johnson and Son, Ltd.

John Hobbs, Procter & Gamble

Taniya Mann, Reckitt Benckiser

Melissa Klamerus, Ecolab

Mannalee Johnson, Ecolab

Health Canada Participants

Barbara J Sabourin, Director General, Therapeutic Products Directorate (TPD)

John Patrick Stewart, Acting Senior Executive Director, TPD

Ian Chisholm, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD

Gail Gervais, Liaison Unit, Office of Business Transformation (OBT), TPD

Sonia Roussel, OBT, BGIVD

Jacques Bouchard, OBT, BGIVD

Lisa Lange, Bureau of Policy, Science and International Programs (BPSIP), TPD

Janet Brunette, OBT, TPD

Hugh Scheuerman, OBT, TPD

Bruce Randall, OBT, TPD

Rene-Pierre Charron, Marketed Health Products Directorate (MHPD)

Kim Dayman-Rutkus, HPFB-Inspectorate

Observers

Marilena Bassi, OBT, TPD

Carolyn Bourque, MHPD

Dalia Haddad, OBT, TPD

Karin Hay, BPSIP, TPD

Lynn Hefferton, OBT, TPD

Heather L. MacDonald, BPSIP, TPD

Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)

1. Welcome and Introductions

Barbara Sabourin, Director General, TPD, HPFB, welcomed everyone and led roundtable introductions.

Organizational Update

Barbara Sabourin provided the following staffing updates at the Directorate level:

• Dr. John Patrick Stewart joined the Director General's Office as the new Acting Senior Executive Director.
• Heather L. MacDonald is the new Acting Associate Director of BPSIP, TPD.
• Marilena Bassi is the new Director of OBT, TPD.
• Dr. Barbara Rotter has retired from her position as Director of the Bureau of Metabolism, Oncology and Reproductive Sciences.

2012 Federal Budget Update

Barbara Sabourin summarized the impact of the 2012 Federal Budget on TPD. She reported that, while review resources were largely protected, there were still impacts within the Directorate. Some functions within TPD were combined or reorganized to create internal efficiencies. The federal budget decisions translated to a loss of 15 positions within TPD.

The other major change outlined in the budget relates to Schedule F, which will be eliminated and replaced by an administrative list of prescription drugs. The process for drug submissions will be unchanged and all drug submissions to Health Canada will continue to be subject to rigorous scientific assessments prior to the assignment of prescription or non-prescription status. Current processes will be upheld until such time that the changes are published in Canada Gazette II and the regulations are updated. It is hoped that these will be ready to implement by spring 2013.

2. Review of Agenda

Item number 8 was moved forward - prior to 3 pm at the request of Lisa Lange.

3. Approval of the Meeting Notes of November 29, 2011

Approved with two clarifications - re Item 12 - remove fifth paragraph re social media/Lucie Desforges. Also same item bar code issue should be replaced by Quick Responses code.

4. Forward Planning Initiatives

Lisa Lange, A/Director, BPSIP, TPD provided an update and handout on several upcoming program policy initiatives within the Directorate.

5. Social Media/MedEffect Canada

Rene-Pierre Charron, Marketed Health Products Directorate (MHPD) provided a presentation giving an overview on the use of social media and the current tools as part of Health Canada and MedEffect™ Canada Initiative as well as providing an overview on MedEffect™ Canada's approach to social media.

There was discussion with regard to US versus Canadian websites (.com versus .ca) and that Health Canada does not monitor what information others put on their websites. This information may vary from country to country.

6. Compliance and Transparency Initiative

Kim Dayman-Rutkus, HPFB Inspectorate provided an update on this initiative. HPFB's strategic direction has, as a key element, an increased focus on transparency. The Inspectorate's current thinking on compliance transparency is focused on achieving the best balance among:

• Effectiveness, for example, positive impact on compliance from information made public;
• Operational feasibility; and
• Technological and legal supportability.

The US-Canada Regulatory Cooperation Council is currently resulting in more emphasis on compliance transparency in the Good Manufacturing Practices (GMP) area however the Inspectorate is looking across all its activities for where its efforts are best directed.

7. Update of the Guidance Document/Regulatory Modernizaton/Additions to the Frequently Asked Questions (FAQ)

Cheryl Fougere, CCSPA indicated that further to the presentations made at the CCSPA Annual Government Interface, they have a number of outstanding concerns that they would like to have addressed. While the Guidance Document Update, Regulatory Modernization and the Update of the FAQ seem to be three separate issues, they feel they are very closely linked and would like to address all of them at the same time.

At the CCSPA Interface, it was communicated that a draft of the Guidance Document (GD) will not be available for review until the end of 2012. This is later than the original timeline for completion of the document. As such, CCSPA offered assistance by way of a CCSPA technical working group to move it forward.

In April 2012, CCSPA President Shannon Coombs met with ADM Paul Glover, Dr. Jacques Bouchard and others to discuss the regulatory modernization agenda within Health Canada. It was communicated in that meeting that the exemptions that CCSPA has been requesting could be put into practice prior to the regulatory changes being completed. Given the timelines for revisions to the guidance document, CCSPA proposed a policy statement be posted on the TPD website. CCSPA offered to provide TPD with language for this statement.

CCSPA also discussed additional items they would like to see addressed in the FAQ, specifically withdrawal of Canadian General Standards Board (CGSB), "Kills Germs" claims and common industry errors.

Jacques Bouchard, BGIVD added that under the current climate when TPD revises documents a great deal of internal consultations and justifications are required. Our goal is to combine everything into one guidance document and have one consultation to review changes so that there is less of a delay for posting.

Ian Chisholm advised that TPD would be willing to share once TPD has received all comments and the document is then revised.

ACTION: TPD to touch base with CCSPA and advise when a document may be available for review after completion of all internal consultations.

8. Pipeline Forecasting/ Performance Statistics

Bruce Randall and Hugh Scheuerman, OBT, provided information on TPD's current pipeline forecasting initiative along with information on performance statistics.

Pipeline data: Currently, TPD is collaborating with industry associations to streamline a mechanism to capture and present drug product pipeline information in a useful way. Although sponsors have been providing pipeline information for several years, the lack of a common approach to providing this information makes it difficult to collate and use the information for planning.

TPD wishes to expand this project by developing a template and soliciting and maintaining drug pipeline information. Using this information TPD will project future workload for the drug Bureaux in a manner similar to the TPD's Workload Management reports (which reflect actual workload). The idea is to implement a template that can be populated by industry and submitted to TPD which can collate all the information received and use it to plan for future workload.

TPD would like to work with CCSPA to refine the approach and template to ensure that quality information can be obtained in a manner that is not overly burdensome to either the industry or TPD. The proposed approach is to have sponsors submit updated pipeline information via the excel template every 6 months (January and July). Knowing that this information can change within the 6 month timeframe, TPD has created an email address to which companies can provide updated information on individual submissions (within certain criteria).

Cost Recovery update: Submission volumes (planned and actual); Cost Recovery revenues (planned and actual); an explanation of how the Pharma submission volume forecasts are created; and role of pipeline data in forecasts was discussed.

Cheryl Fougere, CCSPA indicated that the data would be circulated and feedback solicited to see if the template works for them and will get back to TPD.

ACTION: CCSPA to provide TPD with feedback in regard to their participation in pipeline forecasting.

9. Roundtable

Item 8 - Forward planning was previously discussed.

10. Adjournment

Meeting adjourned at 2:45 pm

11. Next Meeting

Wednesday, November 21, 2012, at 1:30 pm

Original signed by
Barbara J. Sabourin
Director General
Therapeutic Products Directorate