Consultations on improving the regulatory review of drugs and devices

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 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.

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)
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.

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	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.

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	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)

July to December 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)

January to June 2020

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

July to December 2020

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