Final Record of Decisions - October 19, 2017, Meeting with National Association of Pharmacy Regulatory Authorities (NAPRA)
Health Canada - Health Products and Food Branch(HPFB)
Bilateral Meeting Program
1600 Scott Street, Holland Cross, Tower B, 2nd Floor, Boardroom 2048, Ottawa, Ontario
October 19, 2017
(1:00 p.m. to 3:40 p.m.)
Adele Fifield, Executive Director, National Association of Pharmacy Regulatory Authorities (NAPRA), Co-Chair
Ray Joubert, Registrar, Saskatchewan College of Pharmacy Professionals
James Krempien, Complaints Director, Alberta College of Pharmacists
Manon Lambert, Directrice générale et secrétaire, l'ordre des pharmaciens du Québec
Sam Lanctin, Registrar, New Brunswick College of Pharmacists
Susan Lessard-Friesen, Registrar, College of Pharmacists of Manitoba
Nancy Lum-Wilson, Registrar, Ontario College of Pharmacists
Sarah Marshall, Manager, Professional and Regulatory Affairs, NAPRA
Bob Nakagawa, Registrar, College of Pharmacists of British Columbia and Chair, Council of Pharmacy Registrars of Canada
Michelle Wyand, Registrar, Prince Edward Island College of Pharmacists
Bev Zwicker, Registrar, Nova Scotia College of Pharmacists
Barbara Harvey, Registrar-Health Professions, Department of Health, Government of Nunavut
Sarah Jennings, Acting Manager, Professional and Regulatory Affairs, NAPRA
Sarah Marshall, Incoming Manager, Professional and Regulatory Affairs, NAPRA
Theresa Schopf, Manager of Gateway Operations, NAPRA
Health Canada Participants
Marilena Bassi, Director, Bureau of Policy, Science and International Programs (BPSIP), TPD, Co-chair
Janet Brunette, Office of Performance, Planning and Review Services (OPPRS), TPD
Kristen Beausoleil, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate
Rita Beregszaszy, Bureau of Cardiology, Allergy and Neurological Sciences (BCANS), TPD
Léo Bouthillier, BCANS, TPD
Michèle Chadwick, Biologics and Genetic Therapies Directorate (BGTD)
Mandy Collier, OPPRS, TPD
Émile Geoffroy, Regulatory Project Management Division, OPPRS, TPD
Lucye Galand, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
Jenna Griffiths, BPSIP, TPD
Tanja Kalajdzic, Marketed Health Products Directorate (MHPD)
Kelly McClellan, Director General's Office, TPD
Anna McCrum, OPPRS, TPD
Kelly Robinson, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD
Matthew Sanger, Resource Management and Operations Directorate (RMOD)
Donna Watt, OPPRS, TPD
Welcome and introductions
Review of agenda
Approval of meeting notes of September 23, 2016 / previous action items
Regulatory Review of Drugs and Devices (R2D2)
Marilena Bassi, Bureau of Policy, Science and International Programs, Therapeutic Products Directorate (TPD) welcomed everyone to the meeting and thanked the representatives who travel to these meetings as the effort made to participate face to face is appreciated. A roundtable of introductions followed.
A number of organizational changes have taken place within TPD since the last bilateral meeting was held in September 2016. Marion Law left TPD in June 2017 to accept a two-year assignment with the WHO in Geneva. John Patrick Stewart, former Director General of the Marketed Health Products Directorate became the new DG of TPD as of July 17, 2017. Celia Lourenco, formerly of the Bureau of Gastroenterology, Infection and Viral Diseases, is now the Interim Senior Executive Director; Bruce Randall has returned to TPD as Director of the Bureau of Pharmaceutical Sciences; Léo Bouthillier is Director of the Bureau of Cardiology Allergy and Neurological Sciences; Lucye Galand is Acting Director of the Bureau of Gastroenterology, Infection and Viral Diseases; Marilena Bassi is Director of the Bureau of Policy, Science and International Programs; and Mandy Collier is Director of the Office of Planning, Performance and Review Services.
Kendal Weber has returned to the Health Products and Food Branch as A/Associate Assistant Deputy Minister.
Adele Fifield, NAPRA co-chair, indicated that the association appreciates the opportunity to meet with Health Canada.
There were no changes to the agenda.
The meeting notes from the September 23, 2016 meeting were approved and the action items have been completed.
Michèle Chadwick, Lead, Regulatory Review of Drugs and Devices Initiative, Biologics and Genetic Therapies Directorate, presented this item. The Health Products and Food Branch (HPFB) is progressing on projects related to implementation of the Regulatory Review of Drugs and Devices initiative. As part of the Health Minister's mandate letter, there is the will to improve affordability, accessibility and appropriate use of therapeutic products. One means by which Health Canada will work to achieve this is by improving access to therapeutic products to better meet the needs of the health care system.
A presentation was provided outlining key areas of focus for HPFB including:
- Health care system collaboration and international engagement (projects include: Alignment of HTA reviews with Health Canada reviews, Implementing a mechanism for early parallel scientific advice, Use of foreign reviews/decisions and International collaboration and work sharing)
- Timely and appropriate access to therapeutic products (projects include: Expansion of priority review pathways, Improving access to biosimilars and biologics, Improving access to generics, Building better access to digital health technologies, Pre-submission scientific advice for medical devices and Special access programme renewal)
- Real-world evidence throughout the product lifecycle (projects include: Leveraging data for assessing drug safety and effectiveness, and Strengthening post-market surveillance of medical devices); and
- Modernized cost recovery and business systems (projects include: Updating system infrastructure, Appropriate cost recovery framework and Public release of clinical information)
NAPRA asked a number of questions related to the scope of the initiative. Health Canada indicated that it would welcome any comments that NAPRA has on the definition of health care system need. Comments can be sent to Michele.email@example.com. There will be opportunities for consultation as projects develop and TPD will ensure that NAPRA receives all of the notices and proposals.
Michèle Chadwick confirmed that the Biosimilars Fact Sheet is posted on the Health Canada website.
Drug approval process
Émile Geoffroy, A/Manager, Regulatory Project Management Division (RPMD), Office of Planning, Performance and Review Services, TPD, Health Canada provided an overview of the drug submission approval process.
Action: Émile Geoffroy, TPD, to provide NAPRA with an updated presentation. Action Completed: Updated presentation was provided to NAPRA on October 19, 2017.
Opioid warning stickers and patient handouts
NAPRA had participated in the August 2017 consultation and requested the opportunity to discuss outstanding questions and concerns about opioid warning stickers and patient handouts.
Léo Bouthillier, Director of the Bureau of Cardiology, Allergy and Neurological Sciences, Kristen Beausoleil, Office of Legislative and Regulatory Modernization, and Tanja Kaladjzic, Marketed Health Products Directorate, addressed this item. An update was provided on the activities that the Health Products and Food Branch are undertaking as part of the Federal Action Plan on Opioids. These activities include but are not limited to:
i) better informing Canadians about opioid risks by requiring a mandatory warning sticker be applied on containers and an information handout be provided to patients, for all prescription opioids and by
ii) reducing easy access to unnecessary opioids by further updating information in Product Monographs (such as contraindications/warnings and precautions).
NAPRA requested a conversation about the topic and indicated that it would welcome a discussion on how to make pharmacists more effective in their communications to patients regarding opioids. However, NAPRA noted that it continues to feel that mandatory warning stickers and patient handouts are not the appropriate approach, as this solution is not patient-centered and does not allow pharmacists to exercise their professional judgment. NAPRA suggested that Health Canada review the guidelines that some of the provincial/territorial regulatory authorities have developed for their members regarding opioids. Health Canada indicated that it has read the comments that NAPRA submitted for the August 2017 consultation and is analyzing all of the feedback received.
Update on Mifegymiso
In May 2017 Health Canada issued a communication to health care professionals which specifically discussed Mifegymiso distribution and administration. NAPRA requested an update as some provinces have moved ahead with policies allowing pharmacist dispensing of Mifegymiso.
Kelly Robinson, Director, Bureau of Metabolism, Oncology and Reproductive Sciences, TPD addressed this item. Mifegymiso has been available on the Canadian market since January 2017 and several provinces/territories are now reimbursing it. Patients can receive Mifegymiso directly from their doctors. This is a common practice in other countries and was proposed by the manufacturer at the time of the approval. However, some provincial regulatory authorities have advised their members that Mifegymiso can be dispensed by pharmacists, similar to other medications. Doctors and other health care professionals may administer or distribute drugs outside of approved condition of use to treat patients under their responsibility. This is considered practice of medicine or pharmacy and is regulated by the provinces.
Health Canada continues to collaborate with key stakeholders including professional associations, researchers and the provinces to ensure safe and effective use of this drug. The submission to revise the indication and distribution for Mifegymiso was accepted into review by Health Canada in January 2017. The service delivery standard for this type of submission is 300 days. It is anticipated that the submission will be finalized in the near future.
NAPRA indicated that if any of Health Canada's work will affect the professional practice of pharmacists, the association should be consulted early in the process so that it can contribute to a solution. NAPRA also mentioned that, as Health Canada is looking at streamlining the review process, this may present an opportunity to allow for consultation with NAPRA earlier in the process when aspects of a review, such as the Product Monograph, Risk Management Plan or labelling, will affect the practice of pharmacy.
Health Canada noted that it meets regularly with the Patented Medicines Prices Review Board.
Public release of clinical information
Matthew Sanger, Resource Management and Operations Directorate, presented this item. Amendments to the Food and Drugs Act provide Health Canada with new regulation-making authorities to specify when information regarding a therapeutic product authorization is not or ceases to be confidential business information (CBI) and authorize the disclosure of the information.
In March 2017, Health Canada published a consultation paper for public consultation on its proposed policy and regulatory approach to public release of clinical information (PRCI). NAPRA participated in this consultation, including providing written comments on the consultation paper. There was a good response to the consultation paper, with over 40 different submissions from a large number of groups. There was no opposition in principle to the policy objective. Some concern was expressed about creating a burden on industry as compared to other jurisdictions. Industry would like Health Canada to be aligned internationally. A summary of this consultation paper will be posted on the Health Canada website.
There will be a public consultation on the draft regulations. The target is to be operational by November 2018. As part of the draft guidance that is currently being developed, a stakeholder engagement process has been initiated. A call was made in early Summer 2017 which generated a lot of interest. A stakeholder group was formed and it is expected that meetings will be held every four to six weeks. Sarah Marshall will be replacing Sarah Jennings as the NAPRA member on this group.
The stakeholder engagement process focuses on the technical aspects of implementation, and how Health Canada consults with the sponsor. The aspect that is likely to be of the most interest to NAPRA is how user needs are identified in terms of accessibility. The stakeholder group will look at how to measure impacts on the health system. It is anticipated that the results of the stakeholder meetings will be published.
NAPRA indicated that it is interested in obtaining access to as much information as possible as quickly as possible. Health Canada noted that there will be an opportunity to provide more comments when the proposed regulations become available in Canada Gazette 1.
New prescription status for hydroquinone
Lucye Galand, Bureau of Gastroenterology, Infection and Viral Diseases, TPD presented this item. Health Canada has posted a Notice of Intent to Amend and an Information Update on its website on August 29, 2017 confirming its intent to exclude hydroquinone from the Natural Health Products Regulations at concentrations greater than 2 % in products for topical use, once they are added to the Prescription Drug List.
This revision will come into effect 12 months from the date of this Notice, in August 2018. A one-year transition period has been granted to existing products on the Canadian market to allow market access to products for healthcare professionals and patients while the regulatory status of these products is changed. Health Canada intends to regulate these products under Division 1 of the Food and Drug Regulations.
A general guidance letter template was provided to impacted industry stakeholders. Sponsors wishing to maintain market authorization in Canada should submit a (Drug Identification Number) DIN application to TPD in order to obtain a valid DIN number. A formal notice will be released shortly before the August 2018 deadline.
a) Notice of intent for pharmaceutical alternatives
Health Canada is presently consulting about possible changes to the Food and Drug Regulations that aim to create greater alignment and convergence with the practices of other major regulatory jurisdictions and to standardize their use with those applied internationally.
The consultation serves to solicit comments around establishing pharmaceutical equivalence between a proposed generic drug product and the Canadian Reference Product (CRP). Health Canada also proposes to define the meaning of "medicinal ingredient" and other key terms (e.g., therapeutic moiety and drug product). A key element is that generic drug products which contain the same therapeutic moiety in the medicinal ingredient as the reference product, but for which the medicinal ingredient is in a different physicochemical form (e.g., salt form), as approvable under an Abbreviated New Drug Submission (ANDS) provided the differences do not result in a difference in safety or effectiveness.
The full text of the consultation proposal is available on-line and comments are due Oct. 27, 2017. Health Canada would welcome NAPRA's feedback as to whether the proposed changes would impact on the activities or practices of pharmacists in dispensing drugs. NAPRA indicated that it had already submitted feedback on this consultation.
b) Antimicrobial ingredients
There have been minor changes to the "Products for Human Use" portion of the Prescription Drug List (PDL) that have resulted from the switching of 14 antimicrobial ingredients from non-prescription to prescription status by the Veterinary Drugs Directorate. The consultation ended on September 18, 2017 and the comments that were received are being analyzed. A 'Notice of Intent to Amend' is expected to be posted in December 2017. NAPRA indicated that while it routinely comments on PDL notices on the "Products for Human Use" portion, it did not provide comments for this particular notice given its primary relevance was to the "Products for Veterinary Use" portion. NAPRA indicated that they are also engaged with the Veterinary Products Directorate (VDD) regarding VDD's broad anti-microbial resistance initiatives.
c) Professional use products
Health Canada is currently analyzing proposals as to where professional use products will fit once the self-care framework is in place. TPD will be asking NAPRA for input regarding an appropriate balance of oversight and any potential unintended access. NAPRA indicated that it is interested in discussing the scheduling of professional use and self-care products and suggested a meeting between NNHPD, TPD and NAPRA. TPD agreed to NAPRA's request for a meeting to discuss further.
Action: NAPRA to contact Marilena Bassi, Bureau of Policy, Science, and International Programs, TPD to set up a meeting with TPD and the Natural and Non-Prescription Health Products Directorate (NNHPD) to discuss professional use and self-care products.
Closing and adjournment
Marilena Bassi thanked everyone for participating in the meeting.
The meeting was adjourned at 3:40 p.m.
Next meeting - Spring 2018
Original signed by:
Director, Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
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