Association Bilateral Meeting - BIOTECanada - Meeting Minutes - 2011-03-25

BIOTECanada and the Biologics and Genetic Therapies Directorate (BGTD)

Friday, March 25, 2011
9:30 - 11:30am
200 Tunney's Pasture Driveway, Room 0105
Ottawa, Ontario

Attendance:

Health Canada Participants

Elwyn Griffiths, Director General, BGTD (Co-Chair)
Catherine Parker, Office of Policy and International Collaboration (OPIC), BGTD
Stephanie Hardy, OPIC, BGTD
Agnes Klein, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, BGTD
Georgette Roy, Office of Regulatory Affairs (ORA), BGTD
Christopher Antonio, ORA, BGTD
Maria Baca-Estrada, Centre for Vaccine Evaluation, BGTD
Carole Legare, Marketed Health Products Directorate (MHPD)
Karen Timmerman, Office of Legislative and Regulatory Modernization (OLRM), Policy, Planning and International Affairs Directorate (PPIAD)
Randy Duhaime, OLRM, PPIAD

BIOTECanada Participants

John Cockhill, Talecris (Co-Chair)
Graeme Fraser, BIOTECanada
Maria Klapka, Pfizer
Lise Lotter, Sanofi Pasteur
Cathy Lau, Janssen
Jennifer Chan, Merck
Loretta Del Bosco, Abbott
Maria Perrotta, Novartis
Peter Brenders, BIOTECanada
Anita Hammer, Amgen
Larry Colero, Novo Nordisk
Sheila Critchlow, Nycomed
Lynn Buchanan, BIOTECanada
Rocelyn DelCarmen, AstraZeneca
Susan Drohan, Genzyme

1.0 Welcome and Opening Remarks

The co-chairs welcomed everyone to the meeting and gave opening remarks.

E. Griffiths updated BIOTECanada members on recent meetings and activities.

• BGTD met with BIOTECanada's Vaccine Industry Committee last fall and is committed to meeting with them biannually. 
• In December 2010, BGTD, in partnership with the Canadian Stem Cell Network, hosted a Stem Cell Therapies Workshop. A workshop report will be issued and a guidance document to communicate data requirements for stem cell therapies is being drafted.
• The directorate continues to work hard to remain out of backlog and is in the process of implementing a Quality Management System. 
• Mr. Paul Glover, formerly of Health Canada's Healthy Environments and Consumer Safety Branch, took over the role of Assistant Deputy Minister of HPFB earlier this year, replacing Meena Ballantyne.

J. Cockhill gave opening remarks on behalf of BIOTECanada highlighting the priorities identified by BIOTECanada's Health Advisory Board for 2011. These priorities include (1) supporting regulatory modernization initiatives, which includes work on subsequent entry biologics (SEBs) and supporting an orphan drugs policy; (2) improving market and patient access to innovative biotechnology products; and (3) engaging partners, such as the Patented Medicine Prices Review Board (PMPRB) to ensure there is appropriate intellectual property protection for biotechnologies.

P. Brenders informed BGTD that Abbott and GSK recently joined BIOTECanada's Vaccine Industry Committee.

2.0 Regulatory Performance

G. Roy provided an update on BGTD's regulatory performance. While the directorate remains out of backlog, processes are continually being improved in order to be able to make earlier decisions. BGTD is not issuing 15-day clarifaxes when submissions are within 30 days of the target deadline. The use of other communication mechanisms, such as teleconferences and emails are being considered by BGTD and pre-submission meetings are encouraged.

In the future, performance reports will only be posted for one quarter at a time. All other reports will be removed from the website. Additional details on the format of the reports should become available over the next couple of months.

BGTD's Office of Regulatory Affairs (ORA) will continue to alert sponsors as to when a submission is picked up for review, when a clarifax can be expected, and how the review is going so that sponsors can have their teams ready to respond to any questions. Sponsors would like to receive submission project plans upon request. As suggested, BGTD will also discuss internally the different approaches used for clarifaxes (e.g. storing up questions versus raising questions as they arise).

BGTD confirmed that the proposal to eliminate the Notifiable Change category is only applicable to quality pharmaceutical submissions and does not apply to biologic drugs.

3.0 Update on Legislative and Regulatory Modernization

R. Duhaime and K. Timmerman provided an update on legislative and regulatory modernization initiatives.  BIOTECanada was thanked for the comments they provided during the technical discussions on regulatory modernization. All of the comments received, including parking lot items are currently being analyzed by OLRM.

The current focus is on prioritizing which pieces will move forward as regulation in the absence of legislative change. Within BGTD, priority is being placed on modernizing Division 3 (radiopharmaceuticals) and Division 4 (Schedule D biologic drugs) within Part C of the Food and Drug Regulations. If it is decided that regulatory changes are needed to address SEBs or orphan drugs, this would involve amendments to Divisions 1 and 8 (new drugs) and the changes would move forward as a branch level initiative.

BGTD confirmed that there is no intent to implement a regulatory requirement for barcoding of products; compliance will remain a voluntary measure. Industry barcode standards must not interfere with Health Canada label requirements.

The following other updates were shared by HPFB:

• Broader consultations are planned in support of the plain language labelling initiative.
• The scope of the use of foreign reviews pilot project is currently under review.

4.0 Update on Cost Recovery

C. Parker provided an update on the cost recovery initiative. The updated fee regime is expected to come into force on April 1, 2011. It is unknown how a potential election could impact the regulations, but delays are not anticipated.  HPFB has hired additional staff in order to meet the demands of the new cost recovery regulations. Several guidance documents are being updated to reflect the updated fees. These are administrative changes that do not require consultation.

BGTD also signalled that they were evaluating a "stop the clock" initiative, but that the timeline for this initiative would be well after implementation of the new fee structure (2012 or 2013). Different options are being analyzed and industry will be consulted on any proposals.

5.0 Certified Product Information Document (CPID)

BIOTECanada agreed with BGTD's proposal to implement a change in procedure whereby the full CPID is no longer automatically sent with the Notice of Compliance or No Objection Letter. The rationale for this is that the sponsor already has a copy of the revised CPID as it was submitted to BGTD for review and the proposed change will enhance the security of these documents. At the time of authorization, BGTD will send the sponsor a copy of the cover page with the approved date and the control number as well as confirming, via email, that the document on "date" and "version" has been authorized. A full copy of the CPID will be available upon request.

6.0 Risk Management Planning

A. Klein and C. Legare led a discussion on risk management plans (RMP) for biologic drugs. In 2009, MHPD posted a notice on the Health Canada website regarding the implementation of risk management planning and the adoption of the ICH guideline (topic E2E). The notice includes key components of an RMP and outlines criteria which could be used to request an RMP. The European Medicines Agency (EMA) format for RMPs may be used. The use of RMPs helps Health Canada in its move toward a life-cycle approach to regulation and also helps to direct monitoring efforts for specific products. RMP that are submitted as part of an NDS or S/NDS are being reviewed by MHPD. BIOTECanada was also informed that MHPD will be invited to pre-NDS meetings, so that questions on RMP can be addressed.

It was noted that HPFB review of supplemental educational materials, if applicable to a particular product, differs from the focus of the Pharmaceutical Advertising Advisory Board (PAAB) review. HPFB focuses on the safety aspects and the benefit/risk profile of the product.

HPFB is interested in results from any surveys conducted by industry to evaluate the effectiveness of risk management tools, such as educational materials. This information could help to define appropriate thresholds for the determination of the effectiveness of risk management tools and understanding by physicians/health care providers of the product monograph. BIOTECanada members were strongly encouraged to share any such survey results with BGTD.

7.0 Subsequent Entry Biologics (SEB) - EMA guideline on biosimilar monoclonal antibodies

BGTD sits as an observer on the EMA Biosimilar Medicinal Products Working Party that developed the guideline. Health Canada does not intend to formally adopt the EMA guideline, only refer to it. The Health Canada SEB guidance document already recommends that sponsors refer to the product class specific guidelines developed by the EMA. Any specific Canadian adaptations will be communicated on a product-by-product basis.

It was noted by BIOTECanada that the guideline focuses more on differences than similarities. BIOTECanada will share their comments on the draft guideline with BGTD. BGTD is seeking more active participation on the EMA Biosimilar Working Party. Internationally, BGTD has learned that the Pan American Network for Drug Regulatory Harmonization (PANDRH) Biotechnology Working Group is also interested in SEBs.

Action Item
BIOTECanada to provide BGTD with their comments on the draft EMA guideline on biosimilar monoclonal antibodies.

8.0 Roundtable

• The timelines for BGTD's pre-filing effectiveness project are yet to be determined. During pre-submission meetings, BGTD will make an effort to identify what data are essential for regulatory filing purposes versus what is nice to have. 
• BIOTECanada is in the process of responding to a drug shortages letter that was received from the Minister of Health.  It is expected that responses to the letter will help define the department's role in drug shortage issues.
• The pilot project to see how CADTH can work with BGTD pre-approval is still at the exploratory stage.  Both TPD and BGTD have completed one pilot project. There is agreement that this work should not impact on regulatory performance targets and that any requests for information from CADTH would first go through the manufacturer. There are similar concerns internationally related to roles and responsibilities and differences between regulatory authorization decisions and value assessments.

The next bilateral meeting is scheduled for November 16, 2011 (to be confirmed).