Record of Decisions - May 2, 2012, Canadian Generic Pharmaceutical Association (CGPA)

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

• Record of Decisions: Canadian Generic Pharmaceutical Association (CGPA)
• Location: 1600 Scott Street, Holland Cross, Tower A, 2^nd Floor, Boardroom 2121, Ottawa, Ontario
• Date: Wednesday, May 2^nd, 2012
• Start Time: 1:30 p.m.
• End Time: 4:00 p.m.

CGPA Participants

Len Arsenault, Sandoz, Co-Chair

Dawn Culp, Mylan

Gaetano Gallo, Pharmascience

Lul Ogba-Ghebriel, Taro

Sukhvir Hundal, Ranbaxy

Kent Major, Watson

Mathi Mathivanan, Teva Canada Limited

Rajeev Mathur, Ranbaxy

Jo-Anne Soltesz, Sandoz

Julie Tam, CGPA

Scott Tomsky, Ranbaxy

Health Canada Participants

Barbara J. Sabourin, Director General, Therapeutic Products Directorate (TPD), Co-Chair

John Patrick Stewart, A/Senior Executive Director, TPD

Andrew Adams, Bureau of Pharmaceutical Sciences (BPS), TPD

Robyn Blom, Office of Business Transformation (OBT), TPD

Janet Brunette, OBT, TPD

Gary Condran, BPS, TPD

Gail Gervais, OBT, TPD

Lynn Hefferton, OBT, TPD

Nashwa Irfan, Marketed Health Products Directorate (MHPD)

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

Satish Mallya, BPS, TPD

Eric Ormsby, BPSIP, TPD

Bruce Randall, OBT, TPD

Mary Raphael, MHPD

Hugh Scheuerman, OBT, TPD

Mike Ward, BPSIP, TPD

Observers

Marilena Bassi, OBT, TPD

Felicity Jameson, Therapeutic Goods Agency (TGA), Australia

Teleconference

Anne Bowes, Office of Patented Medicines and Liaison (OPML), TPD

Alice Hui, OBT, TPD

Bindu Islam, BPSIP, TPD

Stéphanie Parra, BPS, TPD

Joyce Pon, BPSIP, TPD

Craig Simon, BPS, TPD

Leslie Vrooman, BPS, TPD

1. Welcome and Introductions

Barbara J. Sabourin, Director General, TPD, HPFB, welcomed everyone, and a roundtable of introductions followed.

Len Arsenault, Sandoz, Canadian Generic Pharmaceutical Association (CGPA), mentioned that CGPA was happy to meet with Heath Canada. One of CGPA's main concerns is review performance of Generics Submissions and while improvements have been evident he is eager to hear about how this will be moving forward.

Barbara Sabourin provided an organization update and announced the following changes:

• Barbara Sabourin has now been appointed as Director General for TPD, and John Patrick Stewart, formerly Director of the Office of Clinical Trials (OCT), will be the Acting Senior Executive Director for the next few months. Celia Lourenco from OBT has accepted to act on his behalf. As of April 2nd, Marilena Bassi is the new Director for OBT and Barbara Rotter , Director of the Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD has retired. Kelly Robinson is now the Acting Director of BMORS.
• Barbara Sabourin mentioned that TPD came out fairly well in regard to the impact of Budget Implementation 2012. The new cost recovery fee structure put in place last year helped as did our core business priorities. In total, fifteen positions were affected in TPD, some of which were with Schedule F, Regulatory Amendment Group. After the budget, Schedule F will not exist anymore.
• The Policy functions have changed and will be divided into four areas at the Branch level and the best organizational structure will be determined.
• The whole process will unfold in about six weeks. Some employees are now competing for jobs, while those on the surplus list are either looking for another position, retiring or taking advantage of educational leave opportunities. Across the Branch, we are also aware of the decisions being made in other Directorates. Nashwa Irfan, MHPD informed the group that 11 employees were declared surplus. Kent Major, Watson requested if it was possible to ensure that government directories be updated to reflect these current changes.

2. Review of Agenda

The agenda was accepted as presented.

3. Approval of the Record of Decisions of November 23, 2011

The Record of Decisions was approved as presented.

4. Pipeline Forecasting / Financial Updates / Cost Recovery

A presentation was provided by Hugh Scheurerman, OBT, TPD on submission volumes (planned and actual); cost recovery revenues (planned and actual); and an explanation of how the Pharma submission volume forecasts are created, and the role of pipeline data in forecasts.

Pipeline Forecasting

Health Canada is continuing to solicit pipeline information from CGPA member companies. Responses have been received from several members; however there are still several companies from which information has not been received Bruce Randall, TPD, indicated the pipeline submission data that were received were of good quality and that the information provided would be used to support future workload planning, revenue forecasting and resourcing.

Kent Major, Watson, inquired in regard to how TPD plans their resource allocations. Is this a tool which will be used to assign resourcing? Barbara Sabourin responded by saying that this is exactly where we want to go. Last year, we used the Costing Model (volume projections) which gave us our workload projections for each Review Bureau to help determine the budgets. This does not tell us which areas are increasing or decreasing therefore we also used historical weighted averages along with specific pipeline information.

Kent Major indicated that this was a good initiative and would give TPD better planning tools and budgeting information.

5. Workload / Backlog / Quality of Supplement to an Abbreviated New Drug Submission (SANDS) Submissions

5.1 Workload/Backlog

Kent Major requested an update on workload and backlog of ANDS issues, and the plan and timelines to meet performance targets.

Andrew Adams, Director, Bureau of Pharmaceutical Sciences mentioned that a number of projects are ongoing which will have an impact on the backlog in BPS. The foreign review pilot, queue management, and increases in reviewers are all having a positive impact on the number of decisions made each month in BPS. In response to questions from the Senate and the support of Health Canada's senior management, a plan is being developed to eliminate the backlog.

Andrew Adams noted that in the Chemistry and Manufacturing area of BPS they have doubled the staff working on Generics. New staff has been hired for the satellite office in Toronto and are being trained.

We have already seen an increase in decisions made in the first 3 months of this fiscal year (30 per month versus 2011 when our average number of decisions made per month was around 17). Our goal is to continue to improve the number of decisions and we are well positioned to do so.

The use of foreign reviews will become more helpful as we will be able to use the 'work' someone else has done to help us make our decisions. We are also looking at the queuing of submission to see how this is operating and how we are sequencing submissions (for example, we may find benefits in grouping submissions together or perhaps have a team review a particular product).

Kent Major asked how long it may take to get out of back log? Andrew advised that we are working on a plan which we can share once it is completed.

Andrew Adams noted that pre-evaluation will be eliminated and replaced by screening. This is still being worked out.

Kent Major offered to meet with BPS to collectively look at screening and pre-evaluation issues.

Andrew Adams responded that this is interesting option and it may be useful to create a Working Group to go over this.

ACTION: BPS/CGPA to explore possibility of the creation of a working group to deal with this issue.

5.2 Quality of SANDS Submissions

Andrew Adams commented that they are losing time because the QOS is not properly completed. They would like to receive a good summary/analysis of the data (even with conclusions). The suggested bilats may deal with some of these challenges.

Len Arsenault asked when they may be able to provide the comments on queue management and what it might look like?

Andrew Adams advised that is was still early days and that we need to develop options and analysis. Since this may affect cost recovery we need to minimize any penalties and need to look at review efficiency.

Barbara Sabourin stated that plans need to be developed before the end of June in order for them to have any impact for this coming year. Our overall goal is to minimize penalties and decrease backlog.

6. International Collaboration in the Review of Generic Drugs, including the Generic Drugs Foreign Review Pilot

Gary Condran and Mike Ward provided an update and slide presentation on the status of use of Foreign Review.

Gary Condran indicated that the pilot was planned for 6 months (ending in July) and a company would have been advised if their submission was not accepted.

Kent Major noted the United States Food and Drug Administration (FDA) reluctance to sharing some data and Barb agreed and stated we were currently looking for a 'work around' to this problem. Mike advised that we have met with senior management at the FDA and this issue is being look at for all products. The use of foreign review reports [including for drug master files (DMFs)] represents one of several cooperative mechanisms underway with the Heads of Agency Consortium and the larger International Generic Drug Regulators Pilot. Others include convergence on requirements, review report formats and staff exchanges. Dr. Felicity Jameson of the TGA was now with BPS and soon two senior reviewers from BPS would be visiting the TGA.

Barbara Sabourin indicated that we are appreciative of the helpfulness of the companies involved and we couldn't proceed as we are without their help. We currently have two approvals out using this process and after the pilot we hope to have some 'lessons learned'.

Len Arsenault offered his congratulations to everyone working on this and the momentum of this initiative was very exciting. He would like to keep this on the agenda for further updates at future bilateral meetings.

Julie Tam, CGPA offered special thanks to Mike for his leadership role.

Mike Ward mentioned that they were coming to the point where they would need to cooperate with industry and wanted them to think about points of contact for informal discussions as this moves forward.

CGPA suggested creating a working group for this project. Andrew Adams mentioned we need to let the pilot run to see what we have learned and how to move forward.

7. Review Consistency

CGPA believes that the weekly meetings for review team members and managers have led to some improvement in review consistency. CGPA members would like to continue to provide feedback by sending in questions that are believed to be not consistent with guidelines.

Andrew Adams, advised that the Bureau of Pharmaceutical Sciences has implemented several initiatives aimed at increasing the consistency of review including clarifax questions. Initiatives involve discussions at the senior level within the organization, and methods for disseminating outcomes to the review staff.

Andrew Adams advised that within BPS they have instituted a weekly review practices meeting to improve review consistency and efficiency. The Managers and Senior Advisors discuss issues and clarify the bureau's position. This is documented and communicated to all review staff.

While there is a long list to work through CGPA appreciated and thanked BPS for their efforts.

8. Post Notice of Compliance (NOC) Guidance Issues

CGPA would like to follow up on our suggestion that joint training for reviewers, inspection staff and company staff should be provided. In the last meeting, TPD offered a Question and Answer (Q and A) session to discuss the identified clarifications/inconsistencies in the current guidance. CGPA would also like a workplan to deal with the existing Notifiable change (NC) review. Has TPD seen an increase in SANDS applications and how will it plan for timely reviews in this area?

BPS provided an update on the number of chemistry and manufacturing NCs in queue, and current timelines for their review.

Bruce Randall, OBT, TPD provided data on the impact of the changes to the Post- Notice of Compliance Guidance Document on changes in the number of SANDS received. Andrew Adams and Satish Mallya (BPS) provided an update on the development of the Qs and As document.

Bruce Randall mentioned there was no noticeable spike in the filing of SANDS Chemistry and Manufacturing only since the revisions to the post-NOC policy was put into place, however he would see if this trend continued.

Andrew Adams informed CGPA that Satish is dealing with Drug Shortages at this time.

Andrew Adams responded in regard to the offer of training that he does value training, and asked CGPA to contact him directly.

ACTION: CGPA to contact Andrew Adams to discuss further.

Andrew Adams informed CGPA that BPS will look at what training CGPA would like. He also informed CGPA that more staff are working on Notifiable Changes (NC's).

Andrew Adams indicated that there have been some changes to API and they are hiring a contractor to do this work. They are open to discussions on post-NOC changes/training. They would like to create a Q and A document however this is not a priority at this time.

Kent Major wondered if they could be a conduit (via FSG Board of Directors) to help with organizational training?

Barbara Sabourin indicated that while this may be a good idea it would take time away from review staff to do the training.

9. Auditor General's Report

CGPA: What are the action items that have been developed to address the Office of Auditor General (OAG) report (and possibly Senate Report)? For example, CGPA would like to follow up on our suggestion that TPD provide a weekly list of brand monograph changes. Generic companies believe that this would greatly enhance the timeliness of generic monograph changes.

9.1 Nashwa Irfan, MHPD

Two recommendations were listed by the OAG in regard to post-market surveillance. The first recommendation spoke about the need for improvement in timelines of safety assessments - in December 2011 a review of performance standards was completed, and the signal prioritization process was also revised so that the time decreased between the identification of a signal and the risk mitigation strategies. The second recommendation requested a more systematic process to implement results from safety assessments. In this regard SOPs are being created.

9.2 Bruce Randall, TPD

Ten recommendations were listed by the OAG. The main focus was on improved Health Canada processes. There was also mention of increasing transparency (decision-making). Management did provide a response and an action plan and been developed and is being put into place.

9.3 Monograph Changes

With respect to CGPA's suggestion that the TPD provide a list of brand monograph changes, TPD is working to move ahead with notifying stakeholders of brand monograph changes by posting a chart to the Health Canada website on a monthly basis. The chart will include all brand monographs that have been updated, and it will list the Product Monograph sections that have changed which relate to safety. This type of notification system will require a large amount of manual effort so it is being piloted while TPD develops a more automated and long term process. TPD is looking at options to address the increase in workload generated by the notification system.

Mathi Mathivanan, Teva Canada, inquired about Product Monograph (PM) updates and if TPD would post this on a monthly basis?

Robyn Blom, TPD indicated that the plan was to post these monthly with the safety section identified. We will also need to develop a process on how to deal with incoming notifications starting in 2013.

10. SAC Pharmaceutical Sciences and Clinical Pharmacology

CGPA would like an update on the status of this committee. Has a mandate and timeline been developed yet? Two issues that CGPA would like to be addressed, in-situ salt issue, and Identical Medicinal Ingredient Issue. What is the process for CGPA to engage in discussion on these issues? How can CGPA identify future issues for the committee?

Eric Ormsby, Manager, Office of Science, TPD provided the following updates:

A draft Terms of Reference, which includes the committee's mandate, has been posted on the Health Canada's web site. The inaugural meeting is tentatively scheduled for June 2012.

The Committee will be looking at the issues surrounding the Identical Medicinal Ingredients Policy.

The SAC-PSCP will be holding a two day meeting. There will be opportunity for direct stakeholder involvement, by presentations to the committee, on the first day of the two day meeting. Issues for this committee can be identified at the bilateral meetings or by letter to the Director General.

Len Arsenault inquired on the process to suggest items to the agenda.

Eric Ormsby indicated that the membership has been finalized and will be posted on the Health Canada website. The next meeting is scheduled for June 26-27, with an open session planned for stakeholders. He asked that anyone wishing to present or participate as an 'observer' let him know. Also if anyone had any questions for this Committee to let him know.

Barbara Sabourin stated that this would give us a broader base of expertise whenever we have a complex issue to work on.

11. Canada Vigilance / Electronic Gateway

Mary Raphael, MHPD, spoke on MHPD's initiative - the Canada Vigilance system for ADR where information is currently provided by fax and then data entry. The new system has two components:

1. Electronic gateway: They are currently moving software/hardware and conducting user acceptance testing. The pilot project should begin by the end of June/beginning of July and is targeted towards industries with a large volume of reports. A company would need its own gateway to be able to submit these to us. Health Canada provides them with access keys to establish this connection, then would try some sample reports for a quality check. After this a duplicate system would be in place for a while (fax and electronic) before gradually moving to an on-line system.
2. Web initiative: MHPD is one year away from a Spring 2013 launch. This involves a smaller volume of reports and is a gateway to access Health Canada. MHPD has established a working group with 14 industries represented. Two meetings have taken place so far as they work through the pilot project with plans to finalize this at another meeting planned for the end of May. A communication plan with regular updates is also in the works.

12. Round Table

1. Therapeutic Products Directorate (TPD) Forward Planning Initiatives
   Lisa Lange, Acting Director, Bureau of Policy, Science and International Programs (BPSIP), outlined the initiatives that are currently active and which will require industry input in the near future (a handout was provided at the meeting).

13. Adjournment

Meeting adjourned at 4:00 p.m.

14. Next Meeting

Wednesday, December 5^th, 2012, at 1:30 p.m.

Original signed by

Barbara J. Sabourin
Director General
Therapeutic Products Directorate