Final Record of Decisions - May 18, 2017, Meeting with Groupement provincial de l'industrie du médicament (GPIM)
Health Canada - Health Products and Food Branch (HPFB)
Bilateral Meeting Program
Holland Cross, 1600 Scott Street, Tower B Room 2048, Ottawa, Ontario
May 18, 2017
(1:00 p.m. to 3:00 p.m.)
- Pierre Morin, Co-Chair
- Pranav Pandya (Accord Healthcare)
- Alexandre Ostiguy (Atlas)
- Maïssa Babouder (Euro-Pharm)
- Bruno Zauhar (Euro-Pharm)
- Esther Tremblay (ERFA)
- Patrizia Franco (Jamp)
- Viken Afarian (Lernapharm)
- Yuka Fukushima (Omega)
- Marie-Ève Latendresse (Omega)
Health Canada Participants
- Marion Law, Director General, Therapeutic Products Directorate (TPD), Co-Chair
- Sandra Alderdice, Biologics and Genetic Therapies Directorate (BGTD)
- Ratna Bose, Natural and Non-prescription Health Products Directorate (NNHPD)
- Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
- Michèle Chadwick, BGTD
- Mandy Collier, OPPRS, TPD
- Martin Duplessis, NNHPD
- Émile Geoffroy, OPPRS, TPD
- Celia Lourenco, Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD), TPD
- Vincent Panetta, BGTD
- Bruce Randall, Bureau of Pharmaceutical Sciences (BPS), TPD
- Donna Watt, OPPRS, TPD
- Margaret Zimmermann, Marketed Health Products Directorate (MHPD)
1. Welcome and introductions
Marion Law, Director General of the Therapeutic Products Directorate (TPD), welcomed everyone to the meeting. She announced various organizational changes: Christine Donoghue has taken on the role of Associate Deputy Minister at Health Canada; Tina Green is now A/Assistant Deputy Minister of the Regulatory Operations and Regions Branch; Kendal Weber is A/Associate Assistant Deputy Minister; and Bruce Randall, formerly of the Natural and Non-prescription Health Products Directorate, has returned to TPD as Director of the Bureau of Pharmaceutical Sciences.
Earlier this year, a new Bureau of Medical Sciences Directorate was created in TPD. The Bureau is modeled on other Clinical Review Bureaux and is led by A/Director Kathy Soltys. The Bureau's mandate is to provide medical review expertise, guidance, and the Canadian medical practice context to the regulation of pharmaceutical drugs.
Pierre Morin, GPIM Co-chair, provided an update on an item he had mentioned at two previous bilateral meetings. GPIM had originally indicated concerns that the Minister of Health and Social Services planned to remove the 15% cap on professional allowances that may be paid by generic manufacturers to pharmacists when buying their prescription drug products. The cap on professional allowances was suspended at the end of January 2016. GPIM indicated that while there were a few obstacles, generic companies have passed through this period without a significant negative effect.
A roundtable of introductions followed.
2. Review of agenda
There were no changes to the agenda.
3. Approval of meeting notes of June 16, 2016 / action items
The December 8, 2016 meeting notes were approved.
4. Improving access and use of therapeutic products
Michèle Chadwick, Biologics and Genetic Therapies Directorate, provided an overview of the work underway on the regulatory review of drugs and devices initiative where the goal is to improve access to necessary therapeutic products that meet a health care system need. This initiative is a clear government priority as part of the commitment to work with provinces and territories in the development of a new Health Accord that was outlined in the Health Minister's Mandate Letter.
Specifically, there is a focus on key priority areas where change would yield the biggest results. One of those areas is improved access to necessary prescription medications. Budget 2017 also earmarked support for this initiative.
Key areas of focus for the Health Products and Food Branch include:
- Health care system collaboration and international engagement;
- Timely and appropriate access to therapeutic products;
- Real-world evidence throughout the product lifecycle; and
- Modernized cost recovery and business systems.
Projects under each of these areas of focus include:
Health care system collaboration and international engagement
- Aligning regulatory and health technology assessments
- Providing early advice by Health Canada and health technology assessors
- Enhanced use of foreign reviews to encourage submission filing for products that would not otherwise be available for sale in Canada
- Sharing workload with international regulatory counterparts with regulatory colleagues
Timely access to therapeutic products
- Expanding priority review pathways for drugs that meet health care system needs
- Enhancing reviews of generic drugs, medical devices and biosimilars
- Improving reviews of digital health technologies
- Modernization of the Special Access Programme (SAP)
Enhanced use of real-world evidence
- Using more real-world safety and effectiveness data for drugs and devices across a product's life cycle
Modern and flexible operations
- A robust and agile cost recovery regime
- Modernized business systems-a common submission intake system
- Sharing of data that is not considered confidential business information
Health Canada is interested in receiving feedback from CGPA regarding all of these projects. CGPA indicated that these would be good topics for future bilateral meetings.
Health Canada is interested in receiving feedback from GPIM regarding all of these projects. Pierre Morin, GPIM indicated that this is a major undertaking.
Viken Afarian, GPIM, congratulated Health Canada on its forward thinking but cautioned that history should not be forgotten. He also requested information on what type of information would be considered to be Confidential Business Information (CBI). Health Canada responded that exactly what information is CBI is currently in the process of being defined. GPIM expressed a concern that if a study is done by Company A, then Company B will indicate that there is no need to do another full study if the results of Company A's study are already public knowledge. GPIM also noted that when a company's information is published other companies may copy it. Michèle Chadwick, Biologics and Genetic Therapies Directorate, will pass this information on the Resource Management and Operations Directorate as they are the project lead.
Health Canada has signaled that changes to cost recovery are underway so that Health Canada is in a better position to fund delivery of services. Consultations will be held by Webex on May 26, 2017. GPIM highlighted the importance of face-to-face meetings and indicated that GPIM is available to consult with Health Canada. GPIM added that it is willing to cover travel costs for face-to-face meetings.
5. Results of implementation of the Guidance Document on Human-Use Antiseptic Drugs: Antiseptics for Professional Use
The Guidance Document on Human-Use Antiseptic Drugs entered into effect in December 2009. At that time, GPIM was concerned about the requirements concerning antiseptics for professional use and the cost of meeting these requirements. The association indicated that many products labelled with "for professional or hospital use" are distributed on the Canadian market without meeting Canadian or U.S. requirements. For example, in some hospital settings, there are products that claim to be sterile but are not as determined by the United States Food and Drug Administration (FDA). GPIM indicated that there is substantial risk involved with this claim. Also, hospitals do not want to buy a Canadian-made product that does not have the "for professional or hospital use" label.
GPIM indicated that its main concern is that there are products on the market from companies who have never applied to have their products approved. GPIM expressed another concern about enforcement at the borders. Health Canada responded that when it receives a complaint it takes action but that it is difficult to police products on the pre-market side.
Ratna Bose, Manager, Non-prescription Drugs Evaluation Division, Bureau of Product Review and Assessment, Natural and Non-prescription Health Products Directorate addressed this item.
Health Canada's requirement for "for professional or hospital use" antiseptic drugs has not changed since 2009 publication of the Human-Use Antiseptic Drugs guidance document. Health Canada indicated that if GPIM notices that products that do not meet Canadian requirements are labelled with "for professional or hospital use" the association should contact the Regulatory Operations and Regions Branch. Pierre Morin, GPIM indicated that he has made two complaints. Although both have been acknowledged, he has not received any indication that action has been taken.
Action: Ratna Bose, Manager, Non-prescription Drugs Evaluation Division, Natural and Non-prescription Health Products Directorate requested that GPIM provide her with the communication with the Regulatory Operations and Regions Branch so follow up can be done.
Update: The Natural and Non-prescription Health Products Directorate (NNHPD) has been in touch with the Regulatory Operations and Regions Branch (RORB). They are actively working on the complaint to reach resolution.
6. Harmonization of information from the Drug Facts Table for Non-Prescription Drugs Guidance Document with labelling standards
A new guidance document containing Drug Facts Tables for Non-prescription Drugs was posted on February 20, 2017 for a 60-day consultation period to align with the implementation of Plain Language Labelling Regulations for Non-prescription Drugs taking effect June 13, 2017. GPIM indicated that some of the Drug Facts Tables contain more information than the corresponding Label Standard. The association requested information on whether a harmonization of Labelling Standards with Drug Facts Table information for all the Active Ingredients covered in this guidance is to be expected.
Ratna Bose, Manager, Non-prescription Drugs Evaluation Division, Bureau of Product Review and Assessment, Natural and Non-prescription Health Products Directorate addressed this item. The Drug Facts Table for Non-prescription Drugs Guidance Document will assist manufacturers, packagers, and distributors of non-prescription drugs in developing plain language labelling content for a Facts Table in a standardized format so that consumers can find important product information quickly and easily. The guidance document must be used in conjunction with the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products. The document outlines the formatting specifications to be applied by sponsors and the detailed implementation dates for the Facts Table requirement. The Plain Language Labelling Regulations will come into effect in June 2017 and will require the presence of the Drug Facts Table. The three labelling examples provided by GPIM for this item were determined to be very consistent.
7. Consultation on the Canadian Drug Facts Table (CDFT)
GPIM indicated that the Health Canada consultation on the introduction of the Canadian Drug Facts Table that took place from January 12 to April 5, 2017 deserves to be highlighted for its breadth, for the care with which the organizers listened to respondents, and for the participation of businesses. The association congratulated Pierre Sabourin, Assistant Deputy Minister of the Health Products and Food Branch, who supervised the consultation, and Margaret Zimmermann of the Marketed Health Products Directorate and the members of her team. GPIM noted that this consultation exercise should serve as a model for others as many of the currently proposed changes will have a major impact on existing methods.
Michèle Chadwick, Biologics and Genetic Therapies Directorate, and Ratna Bose, Manager, Non-prescription Drugs Evaluation Division, Natural and Non-prescription Health Products Directorate, addressed this item. Health Canada thanked GPIM for its positive comments regarding the consultation approach used by the team to revise the specifications for the Canada Drug Facts Table. These revisions aim to reduce the need for existing non-prescription drug products to increase package sizes or introduce innovative labels while still maintaining the spirit and integrity of the plain language labelling regulations. They are included in the revised Good Label and Package Practices Guide scheduled for posting on May 31, 2017.
Update: the revised document.
The consultation approach included a number of technical sessions to share information and exchange ideas between Health Canada, industry stakeholders and the packaging industry. Conversations continue regarding a user-friendly and feasible approach to introduce the option of accessing information via a URL for Category IV Monograph products, mouthwash and toothpaste.
Pierre Morin, GPIM, indicated that he wrote to Health Canada recently because the Food Directorate had put together a series of patterns and suggested what could be done. Health Canada responded that a series of fillable templates will be made available. There will be discussions as to what would be involved logistically in order to accomplish this in the future.
Health Canada indicated that a list of Q&As and a form will be posted on the Health Canada Website by mid-June 2017. Pierre Morin, GPIM, noted that this project is a major undertaking. Health Canada will continue to work with industry on the topic.
8. Draft Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs: Reporting Chemistry and Manufacturing (CMC) updates from licensor by licencee in the administrative submissions process
A new guidance document "Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs" was posted on the Health Canada website on February 17, 2017 for a 60-day consultation period. In the case of a licensing agreement where a Drug Identification Number (DIN) submission from a Licensor is referenced by a Licensee, it is stated that any updates to the chemistry and manufacturing (CMC) information and product formulation will be communicated to the licensees to allow them to remain in compliance. GPIM requested guidance regarding the obligation from a Licensee to inform Health Canada of any changes made on the "Original" Licensor DIN submission.
Sandra Alderdice, Office of Regulatory Affairs, Biologic & Genetic Therapies Directorate, addressed this item. To be eligible for administrative processing, all aspects of the submission and application pertaining to the drug product, except for the manufacturer name and/or product name must be identical to those previously authorized for that product. These include, but are not limited to, the submission type, all clinical data, chemistry and manufacturing data, product formulation, strength, route of administration, dosage form, authorized indication(s) and condition(s) of use as well as all product labels.
In addition, licensors are expected to keep licensees up-to-date on any labelling information in order to allow them to file identical updates with Health Canada. With respect to chemistry and manufacturing (CMC) information, the licensor is expected to communicate any relevant CMC updates or issues to the licensee that may affect the approval or marketing of the licensed product. For example, should there be any issues with manufacturing, importation, stability, storage, release or any other general site issues that would affect the safety of the product, or the licensee's ability to source, obtain approval, and market the product, it is expected that the licensor would keep the licensee well informed of these issues.
9. Health Canada update on International Council for Harmonisation (ICH) activities
Celia Lourenco, Director, Bureau of Gastroenterology, Infection and Viral Diseases, TPD, ICH Management Committee Member provided a presentation about the activities and progress made at ICH. Health Canada was an observer at ICH since its inception in 1990, and more recently became a standing member of the new ICH Association. As part of its commitment to ICH, Health Canada will continue to implement ICH guidelines once routine administrative steps have been completed at ICH and within Health Canada.
Health Canada will continue to engage with stakeholders in Canada during the ICH guidance development process. Guidance documents that are at the Step 2 (consultation) stage will be posted on Health Canada's website for a consultation period with a notification sent to stakeholders once published. The Regulatory Cooperation Council initiative with the United States Food and Drug Administration will also continue to be an opportunity for stakeholders to remain aware of the progress of guidance development, and submit questions and comments on ICH guidance documents under revision or development.
Technical and regulatory implementation issues will be addressed as early as possible during the guidance development process with input from stakeholders. Any barriers to implementation will be communicated to stakeholders. (A full listing of Health Canada implemented ICH guidelines.)
Bruce Randall, Director, Bureau of Pharmaceutical Sciences, TPD updated that the consultation for the Quality Guide has ended and TPD is in the process of reviewing the many comments that were received. The Guidance Document is expected to be posted on the Health Canada website in July 2017.
11. Closing remarks and meeting adjournment
Marion Law and Pierre Morin thanked everyone for participating in the meeting. Pierre Morin indicated that while he plans to attend the next bilateral meeting in Fall 2017, GPIM will have a new president by that time. He also highlighted the importance of these bilateral meetings.
The meeting was adjourned at 3:00 PM.
12. Next meeting - November 16, 2017
Original signed by:
Interim Executive Director
Therapeutic Products Directorate
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