Record of Decisions - October 5, 2011, Consumer Health Products Canada (CHP Canada)

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Contact: Office of Business Transformation

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

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

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

Date: Wednesday, October 5, 2011

Start Time: 1:15 p.m.

End Time: 4:15 p.m.

Participants

• CHP Canada Participants
  • David Skinner, Consumer Health Products Canada, Co-Chair
  • Todd Breedon, Johnson & Johnson Inc.
  • Jennifer Denommé, GlaxoSmithKline Consumer Healthcare Inc.
  • Tessa Hogerwaard, McCarthy Consultant Services Inc.
  • Carol Newell, Pfizer Consumer Healthcare, Division of Pfizer Canada Inc.
  • Nicki Smith, Procter & Gamble Inc.
  • Robert White, Consumer Health Products Canada
  • Kristin Willemsen, Consumer Health Products Canada
  • Julie Woo, Schering-Plough Canada Inc.
• Health Canada Participants
  • Barbara J. Sabourin, Senior Executive Director, Therapeutic Products Directorate (TPD), Health Products and Food Branch (HPFB), Co-Chair
  • Andrew M. Adams, Bureau of Pharmaceutical Sciences (BPS), TPD
  • Ratna Bose, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
  • Jacques Bouchard, BGIVD, TPD
  • Mandy Collier, Bureau of Policy, Science and International Programs (BPSIP), TPD
  • Louise Déry, Policy, Planning and International Affairs Directorate (PPIAD)
  • Gail Gervais, Liaison Unit, Office of Business Transformation (OBT), TPD
  • Katie Greenwood, BPS, TPD
  • Nashwa Irfan, Marketed Health Products Directorate (MHPD)
  • Lisa Lange, BPSIP, TPD
  • Denise Quesnel, Liaison Unit, OBT, TPD
  • Barbara Rotter, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD
  • Sonia Roussel, BGIVD, TPD
  • Kim Dayman-Rutkus, Health Products and Food Branch (HPFB)-Inspectorate
  • Hieu Vu, OBT, TPD
  • Osama A. Wahid, BPSIP, TPD
• Observers
  • Andy Hua, OBT, TPD
  • Christine Leroux, OBT, TPD
  • Paul Litowitz, Director General's Office (DGO), TPD
  • Heather L. MacDonald, BPSIP, TPD
  • Virginie Mongeon, Office of Consumer and Public Involvement (OCAPI), HPFB
  • Genevieve Moore, Food and Drugs Act Liaison Office (FDALO)
  • Isabel Renart-McGowan, BPSIP, TPD
• Regrets
  • Supriya Sharma, Director General, TPD, HPFB, Health Canada

1. Welcome and Introductions

Barbara J. Sabourin, Senior Executive Director, Therapeutic Products Directorate (TPD), welcomed everyone, and a roundtable of introductions followed.

Organizational Update:

Barbara J. Sabourin announced that Dr. Supriya Sharma, Director General, TPD, would be leaving Health Canada at the end of the month, to take on a position at the Ivey Centre for Health Innovation and Leadership at the University of Western Ontario.

Katie Greenwood is the Associate Director of the Bureau of Pharmaceutical Sciences. Sonia Roussel is the Associate Director of the Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD.

David Skinner, President, Consumer Health Products Canada (CHP Canada), mentioned that there have been no organization changes within the association. He added that some internal consultations are underway on Regulatory Renewal.

In terms of activities at the TPD, Ms. Sabourin provided the following updates:

• The new user fees have been implemented in April, as part of the cost recovery initiative;
• There is an audit of pharmaceutical programs being conducted by the Auditor-General.
• There are various accommodations changes at TPD:
  • The Nonprescription Drug Evaluation Division (NDED), Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD, moved from the Finance Building, Tunney's Pasture to Holland Cross, Tower A; and
  • Medical Devices Bureau (MBD) moved from the Main Stats Building, Tunney's Pasture to Qualicum, on Baseline Road.

2. Review of Agenda

Some Agenda items were moved in order to accommodate speakers. The Agenda was then approved.

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

Approved as presented.

4. Therapeutic Products Directorate Forward Planning Initiatives

Lisa Lange, 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. Where possible, the anticipated timing of the projects was provided to facilitate the coordination of member input by CHP Canada.

Consumer health products are regulated either as Over-the-Counter (OTCs) by TPD; or natural health products by the Natural Health Products Directorate (NHPD). CHP Canada would like Ms. Lange to touch base with NHPD, to ensure that activities involving consumer health products have the full involvement of both TPD and NHPD in order to promote consistency of approach.

Action: TPD holds regular monthly meetings with NHPD to discuss both policy and operational issues relevant to both Over-the-Counter products and natural health products.

5. Marketed Health Products Directorate (MHPD) Priorities

Nashwa Irfan, Associate Director, Marketed Pharmaceuticals and Medical Devices Bureau, Marketed Health Products Directorate (MHPD), indicated that the MHPD is currently developing its priorities to align with the HPFB priorities for the next three years. At the moment, the focus is on three proposed themes:

• A Modernized Regulatory Framework through Strengthened Post-Market Activities;
• Operational Excellence; and
• People.

The MHPD has a responsibility to collaborate with product specific premarket Directorates such as TPD, Biologics and Genetic Therapies Directorate (BGTD) and Natural Health Products Directorate (NHPD), as well as with other partners, such as Health Products and Food Branch-Inspectorate (HPFB-Inspectorate) and Public Health Agency of Canada (PHAC) on post-market surveillance related activities that include anything from the initial signal detection, signal assessment and risk management of marketed therapeutic products for human use.

The MHPD welcomes a good working relationship with CHP Canada, and ad hoc meetings could potentially be arranged whenever a sufficient number of post-market surveillance issues arise.

There is currently a consultation on the MedEffect Canada website on a Draft Guidance Document The Use of Foreign Reviews by Health Canada. The purpose of this document is to provide guidance to market authorization holders on how Health Canada uses foreign reviews, and how they can help facilitate this use. Recognizing that market authorization holders currently provide foreign reviews to Health Canada, the principles and practices described in this draft document may currently be used, and will serve to formalize the existing practices until such time as the guidance is finalized. This consultation is open for comment starting September 9, 2011 until March 31, 2013.

A public consultation on a Draft Guidance Document for Industry on the review of Health Product Names for "Look Alike, Sound Alike" (LA/SA) attributes is planned for this winter. The proposed document will strive to bring greater scientific validity, transparency, objectivity and predictability to the evaluation of health product names for LA/SA attributes. It will either replace or supplement the current Health Canada guidance for industry on LA/SA name review.

The Canada Vigilance Expert working group (WG) is currently being established (Fall 2011). The proposed mandate of this WG is to provide a conduit for stakeholder engagement in the Canada Vigilance Project, particularly in the electronic reporting of post-market and clinical trial adverse drug reaction information. Canada Vigilance Expert WG will be composed of representatives from HPFB, Information Management Services Directorate (IMSD), and thirteen external stakeholders (Canadian industry, industry associations and clinical trial sponsors).

MHPD is also coordinating an Inter-Directorate Working Group on Acetaminophen and CHP Canada's Acetaminophen Task Force seeks the opportunity to collaborate with this group.

In response to question regarding the role of social media in pharmacovigilance, MHPD indicated that the subject is being considered as it has been raised previously.

6. Health Products and Food Branch (HPFB)-Inspectorate Priorities

Kim Dayman-Rutkus, Director, Policy and Strategic Planning Division, HPFB-Inspectorate, addressed this item.

The Compliance Verification Review was launched last year to make recommendations concerning the efficiency and effectiveness of the program. At the present time, three employees are working on this file and work will continue for the next year. There have been internal cross-country consultations and recommendations should be available in the next year. The Inspectorate is also looking at regulators in other jurisdictions.

The implementation of the Good Manufacturing Practices (GMP) Review was launched last year. A key recommendation being implemented is the risk-based model of the site selection, which introduces a risk assessment of each establishment. The risk ratings that are assigned to establishments are based on an assessment of various factors. Higher risk rated establishments will be inspected more frequently and lower risk rated establishments will be inspected less frequently. In addition, a GMP Update Report will be introduced and tested during this pilot. It is a tool aimed at capturing changes in key personnel, products, processes, facilities, and equipment prior to the conduct of an inspection.

During the first 9 months of the implementation of this recommendation, a WG actively worked on designing the pilot and creating all the relevant documents and tools for industry and for inspectors. The pilot started on target the week of April 26, 2011 and will last for 9 months. The pilot is being run in the 4 western-most Canadian provinces.

The Inspectorate's Compliance and Enforcement Risk Evaluation Guide was developed to outline a structured and analytical approach to evaluate the health risk in support of compliance and enforcement activities. It proposes an evaluation of individual risk factors which contribute to an estimated overall health risk. The guide is intended to inform decision making pertaining to the evaluation of risk and selection of risk management approaches in response to individual incidents of non-compliance.

The Cost Recovery Implementation, including changes related to the establishment licence expiry date, has been a priority for the Inspectorate.

The HPFB-Inspectorate also participated in the Red Tape Reduction Commission. Ms. Dayman-Rutkus talked about the Mutual Recognition Agreement (MRA) versus reviewing inspection reports of foreign sites generated by other national regulatory authorities.

Hieu D. Vu, Acting Director, Office of Business Transformation (OBT), TPD indicated that the Branch is working on a new Branch Strategic Plan, as the current one will expire in 2012. There will be consultations that will build on the current consultation on Regulatory Modernization. In terms of the Drug Master File (DMF) fees, the plan is to move forward with the revised fee as outlined in the consultation document at the end of the fiscal year.

7. Bureau of Pharmaceutical Sciences (BPS) Backlog Reduction Strategy for Over-the-Counter (OTC) Submissions

Katie Greenwood, Associate Director, Bureau of Pharmaceutical Sciences (BPS), addressed the strategy to reduce and eliminate the backlog. She mentioned that BPS does currently have a backlog of Abbreviated New Drug Submissions (ANDSs) and Notifiable Changes (NCs). The strategy to deal with the backlog is focussed on increasing review capacity through hiring and contracting as well as looking at process efficiencies. The elimination of chemistry and manufacturing NCs with the posting of the latest Post Notice of Compliance (NOC) Changes Guidance Documents will also have a positive impact on BPS workload. The Bureau's target is to reduce the ANDS backlog to 25% of workload by the end of the fiscal year.

The revised Post NOC Changes Guidance Documents were posted September 15, 2011, and become effective October 17, 2011. The revised guidance eliminates NCs for chemistry and manufacturing changes to marketed drugs by re-classifying changes as either annual notifications (approximately 60%) or supplemental drug submissions (approximately 40%). Industry's compliance with the requirements of the guidance for annual notifications will be verified via audit. The audit program is currently in the planning phase and will be communicated to industry as soon as it is finalised. The first audits of annual notifications are expected to occur starting in July or August 2012. Ms. Greenwood explained how companies will be affected by the implementation of the revised guidance.

BPS continues to hire new staff. The majority of new staff are chemists, but the Bureau is also hiring biologists and labelling reviewers to ensure there is sufficient capacity in these areas as well. BPS will hire twenty five additional chemists over previous staffing levels. BPS has been successful in hiring well qualified staff, but has been less successful in hiring staff with experience working in the pharmaceutical industry (manufacturing, formulation, etc.). As most of the pharmaceutical industry is located in Toronto and Montreal the Bureau will open a Toronto office on October 11, 2011, and a Montreal office later. Ensuring appropriate training, mentoring and integration into the Bureau of large numbers of new staff presents challenges. The training will address process improvement.

To streamline the contracting process, BPS issued a request for standing offer in July 2011. Bids were due by the end of August and are currently being evaluated. Pending evaluation of the bids and setting up of standing offers BPS continues to use current contractors.

Robert White, CHP Canada, mentioned that the OTC Committee sent a letter on Drug Master File/synthesis, to Health Canada. Andrew M. Adams, Director, BPS, expressed some reservations. Barbara J. Sabourin mentioned that the Guidance is out and this is the one that is being applied. Mr. Adams added that he will be looking at CHP Canada's suggestions and concerns, and explained the appeal process. He mentioned that it was important to have a feedback mechanism.

8. Therapeutic Products Directorate (TPD) Performance

Hieu D. Vu, Acting Director, Office of Business Transformation (OBT), TPD, was pleased to report that the backlog has decreased significantly since last year. He provided comparisons from 2010 to 2011, for Drug Identification Numbers (DIN) Application Workload. DIN Applications backlog by bureaux were also discussed.

Dr. Ratna Bose, Manager, Nonprescription Drug Evaluation Division (NDED), Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD, indicated that during early 2011, the Drug Identification Number Application (DINA) Form and Supporting Data (SD) backlog was mainly driven by sunscreen applications, and some due to inclusion of nanomaterials in formulation. These submissions were causing the most "to-ing and fro-ing" through clarifax.

It would certainly be helpful if information is shared with the industry regarding submission requirements. NDED has been actively communicating with individual sponsors and has delivered presentations on data requirement to different associations hoping to educate the sponsors in increasing the frequency of high quality submissions that would enable NDED to prevent and eliminate backlog.

The number of 'DINA Form and Supporting Data' submissions received has gone up over the years, and NDED has been making every effort to bring down the backlog. The additional data components of these submissions are reviewed by clinical reviewers in NDED. NDED has added one clinical reviewer in its staff this year. The backlog of 30% in the beginning of the year has now been eliminated in NDED.

The Administrative DINA submission is for changes to product name and/or manufacturer name only. Any other change to the labelling falls outside the scope of this type of DIN submission. However, sponsors submitting Administrative DINA submissions continue to ignore the guidance and are being rejected. Dr. Bose outlined the deficiencies that result in submissions being rejected. CHP Canada will arrange a webinar with the goal of improving submission quality. Once the meeting is confirmed, Mr. White will contact Dr. Bose.

Mr. Vu indicated that CHP Canada will be asked to provide data on pipeline to help with improving forecast planning with respect to bureaux workload, revenue and resources.

Action: CHP Canada to arrange a webinar with the goal of improving submission quality.
Update: The webinar took place on December 12, 2011, at 1:30 p.m.

9. Nonprescription Drug Evaluation Division (NDED) Performance

Dr. Ratna Bose, Manager, NDED, BGIVD, TPD, provided a summary of current submission performance for Division 1 and Division 8 OTCs.

During 2011 (January to August), NDED has processed 664 Division 1 and 41 Division 8 submissions. NDED received a large number of Division 1 submissions before the cost recovery came into effect effective April 1, 2011. Due to this very heavy workload, as well as due to resource constraints, the number of submissions not meeting the review target was high. However, Dr. Bose was pleased to report that NDED is now out of its backlog situation and the submissions are being picked up in a timely manner. Dr. Bose asked sponsors to let her know when to expect a large number of Post-DIN Changes at one time, in order to have resources aligned and work distribution.

The review performance for DIN submissions, as well as New Drug Submission/Supplement to New Drug Submissions (NDS/SNDS) is on target from NDED's perspective.

10. Consumer Health Products Development Process

Robert White, CHP Canada, presented the steps industry follows in developing new consumer health products. The presentation included the various steps until it reaches the market, from how a product is created, identified, manufactured, monitored, marketed and launched.

11. Emerging Regulatory Requirements

Osama A. Wahid, Policy Analyst, Bureau of Policy, Science and International Programs (BPSIP), TPD, addressed this item.

The Non-Medical Ingredient Labelling (NMI) regulatory amendment will come into force on May 13, 2012. Currently there are approximately 3,100 non-prescription drug products on the market that may be required to be NMI labelled although many companies currently voluntarily put NMIs on their product labels.

Since July 2011, the number of companies complying with the attestation letter request is growing. Others are using this as an opportunity to inquire about the emerging regulatory requirement and implementation details.

Attestation data will be entered into the Drug Product Database (DPD) for tracking purposes, and the attestation letters will be scanned and stored into another database. Enforcement actions relating to non-compliance are based on Health Product and Food Branch Inspectorate resources and priorities.

Several options were examined by Health Canada to determine the most effective approach for implementing this regulatory requirement. Requesting an attestation letter is an option that seeks to establish a balanced approach in reducing paper burden on companies while providing Health Canada with the ability to track products eligible for NMI labelling and consequently their sponsoring company. In addition, it is less burdensome than reviewing all revised labels which could be costly for industry and for Health Canada. Overall, the request for attestation is deemed an appropriate implementation response in this particular situation, as it establishes early communication with drug sponsors, and tracks products eligible for NMI labelling based on companies' attestation.

The NMI labelling attestation request does not have a clear detrimental effect on growth, competitiveness and innovation. In addition, it is not a long-term compliance burden. Finally, by providing Health Canada with the ability to track products eligible for NMI labelling and consequently their sponsoring company. It supports the health and safety of Canadians.

Barbara J. Sabourin, Senior Executive Director, added that attestation was a more pro-active way to move forward. David Skinner, CHP Canada, would like Health Canada to find ways to reward compliance.

12. Roundtable

1. Use of Foreign Reviews (Pilot)
   Louise Déry, Acting Director, Policy, Planning and International Affairs Directorate (PPIAD), briefly addressed this item.
   
   The goal is to optimize the use of foreign regulatory information in Branch marketing authorization review process, and provide HPFB with consistent and transparent approaches.
   
   The scope of this pilot will include all product line except natural health products and veterinary vaccines. There will be a technical briefing with industry via teleconference in the fall. CHP Canada noted that there was little information provided on the application of foreign documents to support OTC approvals. Barbara J. Sabourin invited CHP Canada to submit their concerns in writing. David Skinner, CHP Canada, suggested adding "OTC" more often in the document.
   
   Action: PPIAD to arrange a teleconference call in the fall.
   Update: The webinar took place on December 12, 2011, at 10:00 a.m.

13. Adjournment

Meeting adjourned at 4:15 p.m.

15. Next Meeting

Wednesday, March 28, 2012 (1:15 p.m.)
Holland Cross, Tower B, Boardroom 2048

Original signed by

Barbara J. Sabourin
Senior Executive Director
Therapeutic Products Directorate