Groupement provincial de l’industrie du médicament (GPIM): Final record of decisions April 15, 2021

Health Canada, Health Products and Food Branch (HPFB)
Bilateral Meeting Program
Virtual
April 15, 2021, 1:00 p.m. to 3:30 p.m.

On this page

• Participants
• Meeting minutes
• Next meeting

Participants

GPIM participants

• Stéphane Lévesque, GPIM (Co-Chair)
• Pierre Morin, GPIM
• Regine Angers, April Pharma
• Ysabelle Foisy, Biomed Pharma
• Antoine Poncy, Ethypharm
• Clémence Odot, Ethypharm
• Bruno Zauhar, Euro-Pharm
• Nora Hachimi, Euro-Pharm
• Maria Helena Albornoz Vasquez, Groupe Sani Marc
• Isabelle Fortier, Groupe Sani Marc
• Françoise Moffette, Jamp Pharma
• Mary Dimitratos, Jamp Pharma
• Inès Ben Jebara, Laboratoire Omega
• Amina Bouzenoune, Laboratoire Omega
• Yuka Fukushima, Laboratoire Omega
• Houria Khelifati, Laboratoire Omega
• Marie-Éve Latendresse, Laboratoire Omega
• Marjaneh Sarir, Laboratoire Omega
• Danny Germain, Laboratoire Riva
• Jacques Lavoie, Laboratoire Riva
• Sophie Vincent, Laboratoire Riva
• Viken Afarian, Lernapharm
• Oksana Nedostup, Lernapharm
• Hind Ray, Mantra Pharma
• Vincent Brault, Nora Pharma
• Patricia Milani, Pharmalab
• Ghislain Domtue, Strides Canada /Pharmapar

Health Canada participants

• John Patrick Stewart, Director General, Pharmaceutical Drugs Directorate (TPD), Co-chair
• Bruce Randall, Senior Executive Director, TPD
• Ian Aldous, Bureau of Medical Sciences (BMS), TPD
• Scott Appleton, Bureau of Pharmaceutical Sciences (BPS), TPD
• Denis Arsenault, Biologic and Radiopharmaceutical Drugs Directorate (BRDD)
• Viviane Bergevin, Regulatory Operations and Regions Branch (ROEB)
• Isabel Brazeau, Regulatory Project Management Division (RPMD), TPD
• Janet Brunette, Office of Planning, Performance and Review Services (OPPRS), TPD
• Chris Chen, Marketed Health Products Directorate (MHPD)
• Heather Cherry, RPMD, TPD
• Mandy Collier, OPPRS, TPD
• Émile Geoffroy, OPPRS, TPD
• Christiane Grisé-Bard, BPS, TPD
• Catherine Hudon, ROEB
• Alice Hui, RPMD, TPD
• Melissa Hunt, Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS), TPD
• Carole Légaré, Office of Clinical Trials (OCT), TPD
• Marc Legrand, Bureau of Policy, Science and International Programs (BPSIP), TPD
• Paul Litowitz, MHPD
• Scott Myres, Assistant Deputy Minister’s Office (ADMO)
• Panyada Phandanouvong, Medical Devices Directorate (MDD)
• Chris Rose, BPS, TPD
• Craig Simon, MHPD
• Jeffrey Skene, Bureau of Cardiology, Allergy and Neurological Diseases (BCANS), TPD
• Elizabeth Toller, Policy, Planning and International Affairs Directorate (PPIAD)
• Donna Watt, OPPRS, TPD
• Bruce Wozny, MHPD
• Kristen Zorn, BPSIP, TPD

Meeting minutes

Welcome and introductions

John Patrick Stewart, Director General, Pharmaceutical Drugs Directorate (TPD), welcomed participants to the second virtual bilateral meeting between the Groupement provincial de l'industrie du médicament (GPIM) and Health Canada. He thanked participants for their flexibility with the continuing virtual format and for taking the time to participate in the meeting. COVID-19 has continued to be a major priority since the last bilateral meeting on October 10, 2020. As GPIM is aware, as part of the government's response to the pandemic, Health Canada has introduced innovative and agile regulatory measures through the use of Interim Orders. Prior to the expiry of all Interim Orders in the Fall of 2021, Health Canada will bring forward transition regulations that will allow many of the flexibilities to remain in place on a longer-term basis.

There have been a few organizational and senior management changes since the last bilateral meeting. Anik Michelle Chartrand has taken on a new position with the Canadian Coast Guard, and Chris Rose has been appointed to the position of Director of the Bureau of Pharmaceutical Sciences in TPD. Marilena Bassi has taken on the role of Director General, Veterinary Drugs Directorate, and Bruce Randall has become TPD's Senior Executive Director. Natalie Page is the new Director General of the Natural and Non-prescription Health Products Directorate.

Stéphane Lévesque, GPIM co-chair, noted that through the Interim Orders, Health Canada has implemented rapid regulatory changes since the beginning of the COVID-19 pandemic. GPIM indicated that its members found 14 drugs that were in shortage during the pandemic. The association requested that a clear purchasing process be implemented in case of another pandemic. GPIM noted that its member companies make their decisions in Canada so they can obtain products quickly. However, the association noted that Heath Canada's rapid pace of modernization is moving too quickly for the association's small member companies. GPIM requested that Health Canada decrease the rate of change or improve current procedures in small increments instead of overhauling the system. Health Canada responded that it has been trying to improve the process and to reduce roadblocks and offer flexibility. Even though Health Canada has tried to communicate these regulatory changes to stakeholders, it is aware that the changes are a challenge for all companies and particularly for small companies.

Review of agenda

There were no changes to the agenda.

Approval of meeting notes / action items of the October 20, 2020 meeting

The October 20, 2020 meeting notes were approved. The action items were completed.

Regulatory innovation

Elizabeth Toller, Associate Director General of the Policy, Planning, and International Affairs Directorate (PPIAD), and Executive Director, Regulatory Innovation, Health Products and Food Branch provided an update on the transition plans for the Interim Orders and also the Regulatory Innovation Agenda which aims to make Canadian health product regulations more flexible. The Interim Orders have played an important role by ensuring rapid access to products related to COVID-19, including medical devices, screening tests, vaccines, and therapeutic drugs. In addition to these Interim Orders, Health Canada's collaboration with stakeholders has helped to overcome major challenges in the distribution of COVID-19-related products on the market and to facilitate access to necessary products in the fight against the pandemic.

Before the Interim Orders expire in Fall 2021, Health Canada will present transition regulations which will ensure that the flexibilities introduced by these measures will be maintained over the long term. These regulations will ensure that products authorized under the Interim Orders will continue to be available for as long as needed and that clinical trials continue uninterrupted. The transition regulation that aims to replace the Interim Order for drugs has already been integrated into the Food and Drug Regulations at the end of March 2021. This allows the sale and marketing of drugs related to COVID-19 to continue past the Interim Order's September 2021 expiry date. Regulatory changes also allow a sponsor for any new drug or vaccine related to COVID-19 to submit an authorization request that can benefit from flexibilities similar to those of the Interim Orders.

The pandemic has demonstrated that it is important to have regulatory flexibility in order to allow quick access to necessary health products. This is why Health Canada will build on the application of the Interim Orders to advance its future modernization work. The clearest example of this is the application of Terms and Conditions on approvals. Health Canada will continue to engage with GPIM and will keep the association informed of the progress. Consultations on the modernization plans for clinical trials are planned for Spring 2021. Update: A consultation on Health Canada's Clinical Trials Regulatory Modernization Initiative was held from May 20 to July 4, 2021.

Substitution of the Active Substance Master File (ASMF)

Christiane Grisé-Bard, A/Manager, Bureau of Pharmaceutical Sciences (BPS), TPD addressed this item. TPD indicated that for a New Drug Submission (NDS) or an Abbreviated New Drug Submission (ANDS) for generics, only a Certificate of Conformity (CEP) is required to support the submission. It is not necessary to file an Active Substance Master File (ASMF) when a valid CEP is available except in the case where the company wishes to submit a change as an annual notification rather than a supplement. Sponsors of a drug product may also be required to provide an ASMF in cases where a CEP is provided in partial support of a submission.

For a change in manufacturing site and/or manufacturer of the drug substance, an ASMF is required if the site has not been previously authorized for another product. If a sponsor is filing a supplement, only a CEP is required. If a product has already been approved by Health Canada, it is not necessary to provide an ASMF. It is only in specific cases where a company is filing an annual notification that an ASMF must be provided. An ASMF ensures that Health Canada has the name and address of the manufacturer or the manufacturing site. In summary, an ASMF is required for a Level 3 annual notification with a CEP unless the product has already been approved.

Action: Christiane Grisé-Bard, BPS, TPD to respond to GPIM's question whether a letter of access needs to be submitted with the ASMF when a valid CEP is available.

Update: Health Canada responded that a letter of access needs to be submitted with the ASMF. Response sent to GPIM by e-mail on April 16, 2021.

Health Canada is planning a process to allow reporting of a change to the drug substance manufacturing site within an Immediate Notification Category. This new category, which will allow the sponsors of the drug product to implement the change when there is a CEP without filing a supplement and without an ASMF. The immediate reporting category is scheduled for testing in September 2021.

GPIM noted that nitrosamine contamination is a challenge and that its members find it difficult to obtain information on drug substances and raw materials. GPIM noted that the Canadian market is small and sponsors are not willing to make extra investments and efforts to respond to Canadian specific requirements. TPD responded that the nitrosamine issue is a global concern. Health Canada chairs Nitrosamine International Strategic Working Group meetings and also a Technical International Working Group on nitrosamines to develop harmonized approaches for acceptable intake limits, risk mitigation and root causes. Health Canada is aware that it is difficult for manufacturers if each country takes a different approach to acceptable levels and ways to manage risks associated with the manufacturing process. The Department is making efforts to align with other jurisdictions but this is a challenge. Health Canada is continuing the dialogue with the United States and other countries.

Canadian Reference Product (CRP) status and identification

GPIM requested information as to whether a company is automatically the Canadian Reference Product (CRP) if it is the only manufacturer on the market. Scott Appleton, Manager, Bureau of Pharmaceutical Sciences, TPD addressed this item. TPD indicated that for the purposes of designating a reference product in bioequivalence studies, there is no official CRP status for a generic product when the innovator is no longer marketed. When a CRP is no longer marketed, paragraph b of C.08.001.1 of the Food and Drug Regulations permits generic drug sponsors to use any of the generics as long as they were compared to the CRP in a bioequivalence study. If there are multiple generic products that were approved based on comparison with the innovator, they could all potentially be considered acceptable to be used in comparative studies. In this case, a rationale provided in an Abbreviated New Drug Submission (ANDS) could be considered on a case-by-case basis.

GPIM noted that bioequivalence studies are not required for injectables. TPD responded that for injectables, if there are any safety updates for that product or that product line, then there would be a class labelling update that would follow. When there are multiple products, Health Canada cannot identify one particular product as the CRP because that would convey that it is endorsing that product. Health Canada cannot post an up-to-date list of all CRPs published on the website because CRPs are subject to change depending on the Drug Product Database (DPD) status of the innovator product. For specific questions relating to CRP, GPIM should contact the Bureau of Pharmaceutical Sciences, TPD.

Notice of Non-compliance (NON) process

Alice Hui, Manager, Regulatory Project Management Division, TPD addressed this item. GPIM indicated that according to the Drug Submission Tracking System (DSTS), several Notices of Non-compliance (NONs) for products under review were issued a few days before the scheduled date of their approval. GPIM indicated that industry makes a significant investment when preparing to manufacture a product. GPIM noted that in anticipation of an approval, its members purchase raw material which has an expiry date and prepare to manufacture the product. When a company receives a NON, it needs to restart the drug review process. GPIM noted that it would be helpful if the sponsor could receive an update on the status of a submission from the reviewer one month before the anticipated approval date. This could flag to the sponsor if there is going to be a problem with the submission that might result in a NON or a Notice of Deficiency (NOD). The sponsor would then be able to plan accordingly. GPIM asked if its members could be given the opportunity to discuss a NON before it is issued because misunderstandings are possible. TPD responded that it will have internal discussions about meeting with the company before a NON is issued to see if there is common ground to find a solution. TPD indicated that it would try to provide more information to sponsors regarding the status of the submissions after they have received a screening acceptance letter.

TPD indicated that since a Clarifax cannot be used to provide new information, a NON gives the sponsor an opportunity to provide the supplemental data. A Clarifax cannot completely replace a NON in the case where additional data is required. GPIM indicated that it received a NON that could have been addressed by a Clarifax. TPD noted that when a NON is issued, sometimes Clarifax comments are also included in order to be of assistance. TPD indicated that it will consider separating out the Clarifax and the NON comments to write them in a clearer way. GPIM requested that Health Canada provide a list of common factors that lead to a NON. As part of planning for next fiscal year, TPD will consider adding the Bureau of Pharmaceutical Sciences Guiding Principles: Communicating Deficiency Comments to Submission Sponsors document for consideration to be updated.

GPIM expressed concern about the number of submissions that require a second cycle review. TPD indicated that it closely follows the number of submissions that need to go through a second review and that there is an issue with the quality of submissions. For its part, Health Canada is making efforts to improve the review time for submissions and has hired more scientists over the last year in order to help with the increased workload due to COVID-19 and drug shortages. Health Canada noted that industry also has a certain amount of responsibility to provide submissions that have the best chance of passing the evaluation. TPD suggested that for a discussion relating to NONs issued for specific submissions, GPIM should contact Chris Rose, Director of the Bureau of Pharmaceutical Sciences, TPD.

GPIM noted that if Health Canada also had the opportunity to pause the review clock, the regulator would have more time to review the submission and this would decrease the chance that a NON would be issued. TPD responded that if GPIM has reason to believe that a NON was issued without a good reason, the association should provide Health Canada with examples. TPD noted that, in general, stakeholders have indicated that they do not want Health Canada to have the ability to pause the review of submissions. During Pause the Clock consultations, stakeholders expressed concern that a pause in review would result in a delay in the approval of submissions. GPIM noted that it believes that its members would agree to the idea of Health Canada being able to Pause the Clock. TPD clarified that Pause the Clock is an option for sponsors who need more time to respond to Clarifaxes and it is not intended to be used by sponsors to avoid receiving a NON, a NOD or to avoid a second review cycle.

Pause the Clock regarding the Management of Drug Submissions and Applications

GPIM requested an update on Pause the Clock in relation to Establishment Licence Applications and the Management of Drug Submissions and Applications. Viviane Bergevin, Manager Drug Establishment Licensing Unit, Health Product Inspection and Licensing, Regulatory Operations and Enforcement Branch (ROEB) addressed this item. For Drug Establishment Licencing (DEL) Applications, Pause the Clock is used to measure performance against the 250 calendar day service standard. As of April 1, 2020, the new "Pause the Clock" mechanism allows for the DEL application clock to be formally paused under specific circumstances.

There are four main triggers which allow the DEL application clock to be paused: deficiencies; applicant requests to delay and inspection; meeting requests; and the opportunity to be heard. Deficiencies refer to any application that lacks information and therefore does not meet the requirements of the Food and Drug Regulations or the intent/scope of the application is not clear. If an inspection is required to process an application, a licence applicant may request a pause in order to delay the inspection. When Health Canada proposes to render a negative decision with respect to a DEL application, a notice is issued to provide the applicant an opportunity to be heard. More information can be found at the following Health Canada links: Management of Applications and Performance for DELs (GUI-0127) and Guidance on Drug Establishment Licences (GUI-0002). GPIM noted that this type of Pause the Clock is optimal because it allows for productive discussions and is more likely to result in the approval of the Establishment Licence.

Management of Drug Submissions and Applications

Denis Arsenault, Co-Lead, Pause the Clock Working Group, Office of Policy and International Collaboration, Biologic and Radiopharmaceutical Drugs Directorate (BRDD) and Heather Cherry, Regulatory Project Management Division, TPD presented this item. As of April 1, 2020, sponsors can use the "Pause the Clock" mechanism that enables the review clock to pause and resume during the pre-market review process. A sponsor can request an extension to pause the review clock, giving the sponsor additional time to respond to a Clarification Request, and thus changing the performance standard date. Pauses cannot be less than five days or more than 90 days per pause. Less than five days would be considered to be an extension without a clock pause. The non-active review time (clock pause period) is not counted against performance target standards. Pause the Clock information is available on the Health Canada website at the following link: Guidance Document: Management of Drug Submissions and Applications. This is a separate Pause the Clock mechanism from the Establishment Licensing process that is used by ROEB.

The scope includes all human drugs (pharma, biologics, radiopharmaceuticals, non-Rx, disinfectants, including submissions under Priority Review/Notice of Compliance with Conditions), veterinary drugs and medical devices. The following are out of the scope of this initiative: administrative submissions (such as name changes); applications for veterinary health products; any submissions in screening; acceptance of additional data during the review process; and joint reviews with other regulatory authorities. Post meeting note: As of July 7, 2021, joint reviews with other regulatory authorities are considered within scope of Pause the Clock. If advice from an External Advisory Body is required, the review clock will pause once the sponsor is notified by Health Canada. This is currently the only situation when the pause would be initiated by Health Canada. BRDD indicated that Pause the Clock appears to work as planned together with the new cost recovery structure and penalty model. All Pause the Clock requests have been granted.

Following Health Canada's presentation, GPIM strongly recommended that Health Canada evaluate the possibility of expanding the triggers for interrupting the review cycle. Expanding these triggers would take pressure off of the time required in the standards and would also lead to greater collaboration between Health Canada and industry. This could avoid a second review cycle and reduce time, resources and workload for both Health Canada and GPIM. Health Canada noted that Pause the Clock has been the subject of consultations with stakeholders and that the intent of this mechanism is not only to avoid a second review cycle but also to provide sponsors with more time to respond to requests for clarification.

Good pharmacovigilance practices as seen through the small business lens

GPIM requested that it be made mandatory to add the name of the Market Authorization Holder (MAH) in Health Canada's Canada Vigilance Adverse Reaction Online Database. The association noted that since the name of the MAH of the product is not always indicated, companies must evaluate all of the adverse reactions for products belonging to other companies. GPIM indicated that doing pharmacovigilance for other companies represents an enormous workload for its small companies and suggested that it would be more useful if companies could focus on their own products.

Paul Litowitz, Manager, Health Product Surveillance and Epidemiology Bureau, and Bruce Wozny, Senior Policy Officer, Office of Policy, Risk Advisory and Advertising of the Marketed Health Products Directorate (MHPD) addressed this item. MHPD indicated that the consultation on Reporting Adverse Reactions to Marketed Health Products – Draft guidance document for industry was open until April 25, 2021 and that MHPD would welcome any comments from GPIM on the topic. MHPD indicated that it is sensitive to concerns related to administrative burden. However, regulatory obligations exist for MAHs to report serious adverse reactions associated with their marketed health products and certain ones that have the same combination of active ingredients which can be sources of safety signals. They contribute to the overall risk benefit safety profile of a health product. MHPD requests that due diligence be exercised when collecting key data elements such as the manufacturer name. Recently, hospitals have been mandated to report serious adverse drug reactions. Health Canada also continues to encourage consumers and health professionals to report the name of the MAH in voluntary adverse reaction reports.

The annual summary report (ASR) required in section C.01.018 of the Food and Drug Regulations includes a concise critical analysis of adverse reaction reports. For the preparation of any ASR, Health Canada expects MAHs to verify the completeness of their records with the Canada Vigilance Database. The ASR includes the MAH's adverse reactions and other information to determine whether there has been a significant change in the benefit-risk knowledge about their product. It is not meaningful to assess the status of a product without knowledge of the molecule in general. As burdensome as it might be, the company's ASR needs to consider all the relevant adverse reactions in the Canada Vigilance Adverse Reaction Online database, and not only their own. MHPD indicated that it will be re-examining the annual summary report mechanism and will be interested in receiving GPIM's comments. GPIM noted that artificial intelligence could be used to identify any trends related to a particular molecule and any potential dangers with upcoming molecules. The association indicated that the European Union is exploring the idea of leveraging Artificial Intelligence in medicines regulation. TPD noted that it would consider GPIM's comments.

Product Monograph Brand Safety Update table

Alice Hui, Manager, Regulatory Project Management Division (RPMD), TPD presented this item. As of February 21, 2013, Health Canada implemented a process to inform generic drug manufacturers of safety labelling changes to the Product Monographs (PM) of brand name pharmaceutical drugs. As a result, Health Canada regularly posts a Product Monograph Brand Safety Update table on its website which reflects updated and/or new safety information in PMs of brand name pharmaceutical drug products (those regulated under Division 8 of the Food and Drug Regulations only). This table identifies the section of the PM that was updated pursuant to a Supplemental New Drug Submission, and is aimed to inform generic drug manufacturers about new safety information for pharmaceutical drug products so that they can update their PMs for health care professionals and Canadians.

There is now a new main model for the Product Monograph and a table of recent significant labelling changes. TPD would like to confirm if this posting continues to be useful, and understand if it is regularly used by GPIM members. For example, TPD is interested in finding out whether it is still necessary to identify the Product Monograph section and update it in monthly tables. TPD assured GPIM that no changes are being proposed at this time. Any comments related to the Product Monograph Brand Safety Update Table can be sent to Alice Hui (Alice.Hui@hc-sc.gc.ca) or the RPMD generic account (rpmd-dgpr@hc-sc.gc.ca).

Bioequivalence clinical trials review timelines

Carole Légaré, Director of the Office of Clinical Trials, TPD presented this item. Bioequivalence (BE) studies are typically used to establish evidence of a high degree of similarity in the bioavailabilities (BA) of two pharmaceutical products (e.g. a generic and innovator) and are used as a basis for market authorization applications for generic drugs. By regulations, all Clinical Trial Applications (CTA) are subject to a 30-day default review period from the date of receipt of a complete application in Health Canada. In 2001, Health Canada introduced a 7-day expedited review process with the goal of reducing administrative burdens and attracting more clinical trials to Canada. Note that the 7-day review period is an administrative target only. Despite the initial increase in BE/BA trials following the introduction of the 7-day target in 2001, the number of Phase I Bioequivalence CTAs that Health Canada has received has decreased rapidly over the course of the last five to ten years.

Health Canada has also noted that there is currently a greater proportion of studies that relate to products that are not intended for the Canadian market. It is becoming more and more difficult for Health Canada to prioritize these requests over studies aimed at meeting unmet Canadian medical needs. During Health Canada's upcoming consultation on Modernizing Clinical Trial Regulations, there are plans to revise the timelines for all types of clinical trials (drugs, medical devices, natural health products, etc.). A consultation document will be made available and GPIM is invited to provide comments.

Update: A consultation on Health Canada's Clinical Trials Regulatory Modernization Initiative was held from May 20 to July 4, 2021. GPIM indicated that bioequivalence studies, like drugs, were transferred to other countries because of the cost savings. GPIM noted that it is important to have bioequivalence studies in Canada in order to be able to study the effects on Canadians. The association also noted that its members need to be able to conduct them quickly when they need to address a Notice of Deficiency.

Update on the Improving Access to Generics regulatory package

Marc Legrand, Manager, Bureau of Policy, Science and International Programs, TPD provided an update on the guidance documents that will accompany the amendments to the Food and Drug Regulations for the Improving Access to Generics regulatory package. Work on the regulatory dossier for improving access to generic drugs supports Part II of the Canada Gazette and related guidance documents. This dossier indicates what Health Canada finds acceptable as an Abbreviated New Drug Submission (ANDS) for which a declaration of equivalence can be issued. This dossier also clarifies the regulatory requirements within the framework of the ANDS for generic drugs containing different forms. For example, there could be different forms of salt or medicinal ingredients compared to the Canadian Reference Product (CRP). For all drugs regulated by Division 8, the regulatory dossier also includes revisions to the labelling provision and indicates that a reference to a medicinal ingredient is a reference in the present form, in the dosage form. Two guidance documents will be published in Part II of the Canada Gazette II. They will demonstrate the guidelines, identification and labelling of medicinal ingredients and the strengths of new pharmaceuticals. The link to Canada Gazette Part I for the Improving Access to Generics regulatory package was published on March 30, 2019: Canada Gazette, Part I, Volume 153, Number 13: Regulations Amending the Food and Drug Regulations (Improving Access to Generics). For any questions on this topic, GPIM can contact Marc Legrand (Marc.Legrand@hc-sc.gc.ca).

Roundtable

There were no roundtable items.

Closing remarks and meeting adjournment

GPIM thanked Health Canada for its patience and indicated that the meeting was constructive. The association is interested in making recommendations and seeking solutions to problems. GPIM noted that its members have been particularly active over the last 14 months in order to find products to ensure that they reach the market. GPIM indicated that Canadian companies should be encouraged to continue to develop products in Canada and this will allow Canadians to become autonomous. GPIM noted that Canada does not want to depend on drugs from other countries and it needs to plan for the possibility of future pandemics. TPD thanked GPIM for its comments and noted that the Canadian federal government places significant importance on increasing the capacity to manufacture products in Canada so that they are always available. TPD indicated that the exchanges during this meeting were very useful and that GPIM's perspective is important. TPD added that it tries to be receptive to the perspectives of manufacturers and associations while maintaining the health of Canadians.

The meeting was adjourned at 3:30 PM.

Next meeting

Fall 2021

Update: Due to the September 20, 2021 federal election, the Fall 2021 TPD/GPIM bilateral meeting will be postponed until Spring 2022.

Signed by:
John Patrick Stewart
Director General
Therapeutic Products Directorate