Record of Decisions: November 25, 2009, Groupement Provincial de l'industrie du médicament (GPIM)

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Contact: Office of Business Transformation

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

Record of Decisions: Groupement provincial de l’industrie du médicament (GPIM)

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

Date: Wednesday, November 25^th, 2009

Start Time: 1:30 p.m.

End Time: 3:30 p.m.

Participants

GPIM Participants

Pierre Morin, GPIM, Co-Chair

Viken Afarian, Lernapharm

Drakhshan Ahman, Lernapharm

Gerald Allport, GPIM

Amina Baljic, Solumed 3M

Ali Khamessan, Euro-Pharma

Richard Marchand, GPIM

Alexandre Ostiguy, Atlas

Esther Tremblay, Erfa

Teleconference

Johanne Lussier, Health Products and Food Branch (HPFB)-Inspectorate

Health Canada Participants

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

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

Jacques Bouchard, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD

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

Adam Gibson, Director General’s Office (DGO), TPD

Natasha Kuran, BGIVD, TPD

Denise Quesnel, Liaison Unit, OBT, TPD

Jean Saint Pierre, HPFB-Inspectorate

Brigitte Zirger, Bureau of Policy, Science and International Programs (BPSIP), TPD

Observers

Thea Mueller, BPSIP, TPD

Bruce Randall, OBT, TPD

Hieu Vu, OBT, TPD

Regrets

Supriya Sharma, Director General, TPD

1. Welcome and Introductions

Barbara J. Sabourin, Senior Executive Director, TPD, welcomed everyone. She extended Dr. Supriya Sharma’s regrets.

Pierre Morin, GPIM, thanked Health Canada for the opportunity to meet and also for providing a bilingual Agenda.

GPIM wanted to add two items to the Agenda:

1. Quarterly Report on Performance; and
2. Final Draft Guidance Document on Antiseptics.

A roundtable of introductions followed.

a) Quarterly Report Performance
GPIM was concerned with TPD’s performance, compared to the Biologics’ side. Barbara J. Sabourin explained the current financial situation. She mentioned that it has been a difficult year for TPD, and that the Branch was running a deficit. She commented on some of the factors that are contributing to the backlog.

Andrew Adams, Director, Bureau of Pharmaceutical Sciences (BPS), TPD, acknowledged the backlog problem and explained what has been done to address the performance issue. He stated that for some periods of time for which performance statistics have been reviewed about 50% of BPS submissions missed target by a few days. This has had a significant effect on overall performance statistics for the Bureau. BPS staff has started to work overtime, but this is not a long term solution and should generally be a response for peak workload periods.

The Bureau is also working with its maximum capacity of contractors. The Bureau will reduce other non-review related activities over the short to medium term including training for example. In 2008-2009, there was a significant commitment to training with universities. While training is important and will continue, it will be at a lower level than in 2008-2009. In January 2010, BPS hopes to be in a position to engage additional contractors. This will depend in part on establishing a training program and orientation sessions. BPS is now focussing on core review activities. At the present time, because of reductions of other activities, there are 2 additional full-time equivalents (FTE) of review time. Mr. Adams stated that when the current assignments expire, they will not be renewed and staff will be returning to BPS.

BPS needs to evaluate the impact of process changes such as integrated review. The evaluation will address the cost to the Bureau, the workload resources balance, analysis of workload and time needed to perform daily activities. This will help build the case to justify additional resources if needed. In terms of timing to notice improvements in performance, Mr. Adams did not commit to timelines.

b) Final Draft Guidance Document on Antiseptics
This item was addressed under Item 6.

2. Review of Agenda

Approved

3. Approval of the Meeting Notes of May 27^th, 2009

Approved

Follow-up from Previous Meeting:

(Item 4) Proper Timing for Listing a New Facility on Establishment License
Andrew Adams, Director, BPS, mentioned that in terms of stability batches, there is opportunity for flexibility. A batch has to come from a Good Manufacturing Practices (GMP) compliant facility. Mr. Adams invited GPIM to contact his Bureau for clarity if needed.

4. Cross License Documentation and Responsibilities

GPIM would like the ambiguities issue around cross licenses and inspections to be resolved.

Brigitte Zirger, Director, Bureau of Policy, Science and International Programs (BPSIP), mentioned that the Office of Business Transformation had kindly provided the resources to do the issue analysis. This person is now on maternity leave, and BPSIP does not have the resources to move forward on this issue at the present time. Barbara Sabourin added that, the issues have been identified, but given the current financial situation, it is not considered a priority.

5. Notifiable Changes (NC): Better Timing

GPIM would like TPD to find a way to obtain No Objection Letters (NOL) in about the same time that the product is ready to be marketed instead of more than 90 days after the end of the first lot.

Andrew Adams, Director, BPS, mentioned that BPS recognizes that the submissions requirements of the Post-Notice of Compliance (NOC) Changes Guidance Documents (September 30^th, 2009) may result in a situation where companies have to manufacture product that cannot be marketed for 90 or more days while a submission is filed and reviewed. With the issuance of the Post-Notice of Compliance (NOC) Changes Guidance Documents earlier this year, TPD is only asking for the submission of information to support a change, and is only requiring approval of a change prior to implementation, when it is necessary to protect the health and safety of Canadians. Under the new guidance documents, some changes that were previously submitted as an NC are now subject to annual notification.

Mr. Adams encouraged manufacturers to use the new guidance documents and update their procedures accordingly.

The issue of drug shortage, especially when no alternative medication is available was raised. Could patients rely on the Special Access Program (SAP)? Adam Gibson, Senior Advisor, Director General’s Office (DGO), mentioned that the SAP has been used on a case-by-case basis, but would be the last resource.

6. Draft Guidance on Human Use Antiseptics

GPIM received a copy of the draft Guidance on Human use Antiseptics and extends commendations to the drafters for the coherent and comprehensive approach. It does, however, raise reservations specifically about the section on antiseptics for professional use. These are of two different orders: the first being that, in GPIM’s opinion, allowing a label to carry the statement that the product “is effective against HIV or hepatitis C” is conducive to creating a false sense of security with the user when it is well established the pathogens causing these afflictions are not transmitted in that manner. The second reservation deals with the requirements for in vivo testing that are deemed excessive, and carry a financial burden that exceeds the capacity of most Canadian companies and which may no longer be relevant.

6.1 Pierre Morin commented on the current H1N1 flu pandemic has raised awareness on the use of antiseptic products and created unexpected demand for products. Would Health Canada consider approving new products on in vitro data only?

Given that disinfectants and sanitizers are generally sourced by general purchasing, GPIM would like Health Canada to remind health establishments about the risks of disinfectants and sanitizers. Hospitals should be encouraged to purchase products with a Drug Identification Number (DIN) or a Natural Product Number (NPN).

Dr. Jacques Bouchard, Director, BGIVD, mentioned that Sanitizer Notices have been developed. He added that Health Canada approves the product to be used by a professional in a hospital setting. Health Canada’s focus is to ensure that the claims are real.

Natasha Kuran, Non Prescription Drugs Evaluation Division (NDED), BGIVD, mentioned that Health Canada distributed the final version of the Human-Use Antiseptic guidance document to key stakeholders, including GPIM, on November 10, 2009. The document will be posted to the Health Canada website by the end of November 2009, and will be effective once posted.

Health Canada requires that products demonstrate efficacy and safety under the conditions of use outlined for the product. Further, in vitro data does not necessarily correlate to efficacy in vivo. As such, human use antiseptics must demonstrate efficacy against organisms in vivo and not based solely on in vitro data.

6.2 How does Health Canada plan to implement the new guidance on Human Use Antiseptic products in the future? Will the guidance document apply to the same level for products that are currently on the market? Will the same review cost structure be applied as well?

Natasha Kuran, NDED, BGIVD, mentioned that it was Health Canada’s expectation that manufacturers of professional use products would seek the new enhanced labelling outlined in the guidance, for example - the in vivo test methods (example “Meets EN 1500”) may now be reflected on the label in cases where the data requirements have been met. Health Canada will be communicating the updated expectations and labelling to healthcare practitioners and food handlers. In addition, the Drug Product Database and the Licensed Natural Health Products Database will now reflect which products have been authorized for professional, commercial and/or personal use. Products authorized for use in professional food premises are listed on the Canadian Food Inspection Agency (CFIA) website.

Ms. Kuran mentioned that if Industry wants to upgrade a product, data will have to be provided, and demonstrate that the current label meets standards. It is a case-by-case basis. The drug product database will recognize if the product has been authorized for its use.

The guidance document is final. Health Canada will consider GPIM’s comments and see if they can provide additional clarification.

Manufacturers of authorized products intending to upgrade to the enhanced labelling outlined in this guidance should file according to the relevant sections of the Post-DIN Changes guidance document or the Post Licensing Guidance Document as appropriate. There are currently no cost recovery fees for natural health products. Cost recovery fees for drugs will be dependent on the type of data provided for assessment, and are as outlined in TPD’s Submission Fee Form.

6.3 How does Health Canada intend to use the data to police claims that now require data, but were in a grey area in past.

Jean Saint Pierre, Manager, Drug Compliance Verification and Investigation, HPFB-Inspectorate, addressed this issue.

Although the Inspectorate does some proactive compliance monitoring of products on the Canadian market, the majority of the work accomplished is from concerns or complaints received by Health Canada (1). Heath Canada’s Inspectors are responsible to initially assess the risk to health associated with a complaint and product. A Health Hazard Evaluation can be requested to quantify the risk and guide, along with other relevant information, the Inspector’s follow-up actions. Enforcement of noncompliant products is done on a case-by-case basis, and is relative to the risk posed by the product in question.

Note 1. Two guides are available on Health Canada’s website to help to relay all required information to the Inspectorate.

Regulated parties that market drugs, including disinfectants, have the responsibility for the safety of the product they sell, manufacture, import or distribute to the Canadian public. The parties must comply with all requirements. When non-compliance is brought to the attention of the regulated party, it is the regulated party’s responsibility to take timely and appropriate action to comply with legislative and regulatory requirements.

Compliance is normally achieved through cooperative approach among the regulated party. Compliance actions may include a stop sale or a recall, forfeiture, detention and product disposal.

Additional regulatory measures include customs targets, issuance of regulatory letters, and issuance of public communications, licence suspensions, searches and prosecutions.

Finally, a number of enforcement options are available in instances when a regulated party is unable or unwilling to correct non compliance associated with the products of the regulated party.

7. Roundtable:

a) Guidance on Health Canada website
Jean Saint Pierre, Manager, Drug Compliance Verification and Investigation, HPFB-Inspectorate, explained the procedure for submitting a complaint. Mr. Morin asked if there was a mechanism to answer for reconsideration on risk assessment when there is a request for recall and provision for reconsideration. Mr. Saint Pierre stated that there was usually a dialogue with the company to fully comprehend the risks. GPIM was invited to write to Health Canada if it feels that there was an information gap.

8. Adjournment: Meeting adjourned at 3:30 p.m.

9. Next meeting:

Wednesday, May 5^th, 2010 at 1:30 p.m.

Original signed by

Barbara J. Sabourin
Senior Executive Director
Therapeutic Products Directorate