Consultations on improving the regulatory review of drugs and devices
Current Status: Open
We are improving the regulatory review process of drugs and medical devices in Canada.
We are committed to openness and transparency and we want you to have your say throughout the process.
We will host consultation sessions both in-person and online, ending in 2021.
Join in
From 2017 until 2021, we will hold consultations:
- in-person
- online via WebEx, electronic questionnaires and requests for comments on draft regulations published in Canada Gazette I
Who is the focus
- patients and patient groups
- health care professionals and partners
- industry and industry associations
- academia
- regulators at home and abroad
When and where
Consultation sessions began in September 2017. Please see our table below for information on dates and locations of upcoming consultations. Any added sessions or changes will be posted in the table.
Please visit regularly for updates.
How to participate
Dates and locations for upcoming consultations can be found in the table below, along with links to register (where applicable).
Space may be limited for some consultation sessions.
Consultation sessions dates, location and status
| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Publication of a Notice of Intent to solicit comments on possible changes to the Food and Drug Regulations regarding establishing equivalence between a proposed generic drug product and the Canadian Reference Product (CRP) | June to October 2017 | All interested / affected stakeholders | Online | Completed |
| Stakeholder and expert consultations on Public Release of Clinical Information | October 2017 to April 2018 | All interested / affected stakeholders and experts | Targeted in-person and online consultations | Completed |
| Public consultation on draft regulations for public release of clinical information | December 2017 to February 2018 | Public and all interested / affected stakeholders | Online |
Completed |
| Use of foreign decisions to support access to products that meet an unmet medical need and are not marketed in Canada | February 2018 | Targeted stakeholders | Teleconferences by invitation only / Request for written feedback | Completed |
| Concept of health care system need (to support drug review prioritization decisions) | March to April 2018 | Targeted stakeholders | Online questionnaire | Completed |
| Regulatory Review of Drugs and Devices: information sharing and consultations | March 20, 2018 | Biologics and Genetic Therapies Directorate (Health Canada) and BIOTECanada Biologics Regulatory Affairs Group (BRAG) | Ottawa BGTD-BIOTECanada Annual Regulatory Workshop |
Completed |
| Regulatory Review of Drugs and Devices: information sharing and consultations | March 22, 2018 | Canadian Organization for Rare Disorders (CORD) | Ottawa Workshop |
Completed |
Note: Dates are subject to change and additional locations may be added. When these become available, we will update them. |
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| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Publication of a Notice of Intent to draft regulations to strengthen the post-market surveillance and risk management of medical devices in Canada | April 2018 | All interested / affected stakeholders | Online | Completed |
| Publication of a Notice to Industry - Expression of Interest in Joint Reviews (with other international regulatory authorities) | April 2018 | All interested / affected stakeholders | Online | Completed |
| Public consultation on draft guidance document on Public Release of Clinical Information | April to June 2018 | Public and all interested / affected stakeholders | Online: request for comment on draft guidance | Completed |
| Regulatory Review of Drugs and Devices: information sharing and consultations | May 2018 | Canadian Association of Professionals in Regulatory Affairs (CAPRA) | Ottawa Workshop |
Completed |
| Regulatory Review of Drugs and Devices: information sharing and consultations | May 23, 2018 | Industry, academia and other interested / affected stakeholders | Toronto Joint Conference of the Canadian Society for Pharmaceutical Sciences (CSPS), Canadian Society of Pharmacology and Therapeutics (CSPT) and Canadian Chapter of Controlled Release Society (CC-CRS) |
Completed |
| Publication of a Notice to Industry on the process for aligned review of products | Spring 2018 | Industry and other interested/ affected stakeholders | Online | Completed |
| Stakeholder and expert consultations on Digital Health Technologies | June 2018 | Targeted stakeholders | Targeted in-person consultations |
Completed |
| Regulatory Review of Drugs and Devices: information sharing and consultations | June 27, 2018 |
Targeted stakeholders by invitation | Ottawa Health Products and Food Branch (HPFB), Health Canada Stakeholder Engagement Session |
Completed |
| Stakeholder consultation on usability and value of Health Canada's eLearning course on Premarket Medical Device Regulation | June 2018 | Targeted stakeholders | User accounts were created to allow participants to access eLearning portal | Completed |
Note: Dates are subject to change and additional locations may be added. When these become available, we will update them. |
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| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Publication of a Notice to medical device manufacturers for expression of interest - Device Advice: Health Canada launching a new pilot project to offer regulatory advice to medical device manufacturers | July 2018 | All interested / affected stakeholders | Online | Completed |
Note: Dates are subject to change and additional locations may be added. When these become available, we will update them. |
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| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Public consultation on draft guidance document on medical device cybersecurity | Fall 2018 | All interested / affected stakeholders | Online: request for comment on draft guidance | Completed |
| Public consultation on draft guidance document on 3D printing of medical devices | Fall 2018 | All interested / affected stakeholders | Online: request for comment on draft guidance | Completed |
| Regulatory Review of Drugs and Devices: information sharing and consultations | October 1-4, 2018 | All interested / affected stakeholders | Vancouver Regulatory Affairs Professionals Society (RAPS) conference |
Completed |
| Real World Evidence (RWE) Summit, in partnership with the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institute of Health Economics (IHE) | October 21, 2018 | Targeted stakeholders | Toronto | Completed (Summary Report) |
| Consultations on environmental scan on real-world data and evidence for medical devices in Canada | October 2018 | Targeted stakeholders | Online and telephone interviews | Completed (Environmental scan highlights) |
| Information session on proposed post-market regulatory changes for medical devices | November 22, 2018 | Targeted stakeholders | Web-based information session | Completed |
Note: Dates are subject to change and additional locations may be added. When these become available, we will update them. |
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| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Final consultation on a draft guidance document identifying software subject to Canada's Medical Devices Regulations | Winter 2019 | All interested / affected stakeholders | Online: request for comment on draft guidance | Completed |
| Public consultation on draft regulations regarding establishing equivalence of a proposed generic drug product and the Canadian Reference Product (CRP) and related terminology | Winter 2019 | All interested / affected stakeholders | Online: request for comment on draft regulations
|
Completed (consultation closed on May 31, 2019) |
| Public consultation on draft guidance documents: (i) Identifying and Labelling Medicinal Ingredients and (ii) Generic Drug Equivalence: Medicinal Ingredients | Winter 2019 | All interested / affected stakeholders | Online: request for comment on draft guidance documents | Completed (consultation closed on June 17, 2019) |
| Publication of a Notice of Intent to transition the product monograph to a structured format | Winter 2019 | All interested / affected stakeholders | Online | Completed |
| Public consultation on the draft guidance document: Preparation of Product Monographs in the Extensible Markup Language Format | Winter 2019 |
Industry and other interested / affected stakeholders | Online | Completed |
| Device Advice: Pre-Clinical Meeting Pilot Project | January to March 2019 |
By invitation only to targeted stakeholders who applied to the Expression of Interest Notice | Ottawa | Completed |
Note: Dates are subject to change and additional locations may be added. When these become available, we will update them.
| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Publication of a draft guidance document on concept of health care system need (to support drug review prioritization decisions) | Spring / Summer 2019 | All interested / affected stakeholders | Online: request for comment on draft guidance document | Completed (consultation closed on July 21, 2019) |
| Special Access Programme Renewal | Spring / Summer 2019 | All interested / affected stakeholders | Online: request for comment on draft guidance document and draft regulations | Completed (consultation closed on July 19, 2019) |
| Sale of Drugs - Public or Canadian Armed Forces Health Emergencies | Spring / Summer 2019 | All interested / affected stakeholders | Online: request for comment on draft guidance document and draft regulations | Completed (consultation closed on July 19, 2019) |
| Public consultation on the draft guidance document: Preparation of Drug Regulatory Activities in the Electronic Common Technical Document (eCTD) version 4 Format | Spring / Summer 2019 | Industry and other interested / affected stakeholders | Online: request for comment on draft guidance document | Consultation open until August 26, 2019) |
| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Consultation on Proposed Regulations Amending the Medical Devices Regulations (Post-market Surveillance) | Summer 2019 | Industry and patient groups | Online | Completed (consultation closed on August 26, 2019) |
| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Public consultation on the draft guidance document: Device Advice: Medical Device Meetings | Upcoming | All interested / affected stakeholders | Online: request for comment on draft guidance | Upcoming |
| Topic | Date | Target Audience | Location | Status |
|---|---|---|---|---|
| Discussions on the "Improving Access to Generics" regulatory package | December 4 and 9, 2020 |
Canadian Generic Pharmaceutical Association | Online: teleconferences | Completed |
Note: Dates are subject to change and additional locations may be added. When these become available, we will update them.
Contact us
Regulatory Review of Drugs and Devices
Health Products and Food Branch
Health Canada
100 Eglantine Driveway, Room 3303
AL 0603B
Ottawa, ON
K1A 0K9
Email: hc.regulatory_review-examen_reglementaire.sc@canada.ca
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