Consultations on improving the regulatory review of drugs and devices

From: Health Canada

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

Summer 2017 to March 2018
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.

April to June 2018
Topic Date Target Audience Location Status
Publication of a Notice of Intent to draft regulations on strengthening the use of real world evidence and regulations for medical devices 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.

July to August 2018
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.

September to December 2018
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)
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.

January to March 2019
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
Consultation open until 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.

April to June 2019
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 Consultation open until 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 Consultation open until 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 Consultation open until July 19, 2019
Use of Foreign Reviews Spring / Summer 2019 All interested / affected
stakeholders
Online: request for comment on draft guidance document Upcoming

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 Upcoming

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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