Medical Writing • Clinical Research • Scientific Affairs

Rédaction scientifiqueRecherche cliniqueAffaires scientifiques

You will find in this section links to information on regulations and requirements for the development, approval, promotion, and reimbursement of drugs in Canada.

Please scroll down to see the various topics.


Clinical Research – Drug Products

How Drugs are Reviewed in Canada



Acts and Regulations

Clinical Trials – Guidance & Guidelines


Drugs and Health Products

Health Products and Food Branch (HPFB)


Therapeutic Products Directorate (TPD)

Patent Register

Food and Drugs Act and Food and Drug Regulations


Patent Act


Patented Medicines (Notice of Compliance) Regulations


Patented Medicines Regulations, 1994


Canadian Intellectual Property Office: Patent

Health Canada Guidance documents


International Conference on Harmonisation (ICH)


Good Clinical Practice: Consolidated Guideline


Declaration of Helsinki

NIH Clinical Trials Toolkit

SPIRIT Statement

ICF Research Branch

Ethical Conduct for Research Involving Humans

Clinical Trials – Registries 

Drug Information 

Drug Classification

Health Canada Clinical Trials Database


Current Controlled Trials


EU Clinical Trials Register

Canada Trials

Drug Product Database


Notice of Compliance Database


Summary Basis of Decision


American Hospital Formulary Service (AHFS)


Anatomical Therapeutical Chemical (ATC) Classification System / defined daily dose (DDD)



Disease Information

Data Reporting 

CADTH Search

Cochrane Library

NICE Clinical Knowledge Summaries


NLM Gateway





Centers for Disease Control and Prevention


Merck Manual      


Impact factor


Key reporting guidelines EQUATOR Network


PubMed Central Journal List


Dictionaries & Glossaries


Clinical Practice Guidelines

Glossary - Medical Council of Canada


HTA Glossary_En


Language Portal of Canada









Databank of Official Statistics on Québec




Statistics Canada


WHO Statistical Information System





Alberta Toward Optimized Practice


British Columbia's Guidelines and Protocols Advisory Committee


Canadian Practice Guidelines


Canadian Task Force on Preventive Health Care


Guidelines Advisory Committee


Institute for Clinical Evaluative Sciences


Public Health Agency of Canada -Disease Prevention and Control Guidelines


Market Access


Canadian Pharmaceutical HTA and Reimbursement Processes (Note that information needs to be updated; Last update Feb 2011)



Formulary Drug Listings 

Submission Requirements

Health Technology Assessments & Recommendations


Common Drug Review


Common Drug Review

The pan-Canadian Oncology Drug Review (pCODR)

CADTH/ACMTS Health Technology Assessments

CEDAC/CCCEM Recommendations 


Health & Wellness Drug Benefit List




Institute of Health Economics (IHE)

Alberta Health Services Health Technology Assessment and Innovation

University of Alberta/Capital Health Evidence-Based Practice Center

University of Calgary/The Institute for Advanced Policy Research

Health Technologies and Services Policy Unit

British Columbia

Pharmacare Drug Benefit List


British Columbia


Centre for Health Services and Policy Research  

Assessment of Technology in Context

Centre for Clinical Epidemiology & Evaluation


Drug Interchangeability Formulary Regulation


Manitoba Centre for Health Policy

New Brunswick

Prescription Drug Program Formulary

Atlantic Common Drug Review

Horizon Health Network

Nova Scotia


Atlantic Common Drug Review


Prince Edward Island

Drug Cost Assistance Programs Formulary

Atlantic Common Drug Review


Newfoundland and Labrador

Interchangeable Drug Products Formulary

Atlantic Common Drug Review

Newfoundland and Labrador Center for Applied Health Research


Drug Benefit Formulary




Institute for Clinical Evaluative Sciences

Ontario Health Technology

Advisory Committee and Medical Advisory Secretariat

Institute for Clinical Evaluative Sciences

London Health Sciences center/High Impact Technology Evaluation

Evidence-Based Practice Center/University of Ottawa

Evidence-Based Practice Center /McMaster University

Toronto Health Economics and Technology Assessment Collaborative/ University of Toronto

Technology Assessment at Sick Kids /Toronto Sick Kids Hospital


Liste des médicaments assurés




Institut national d'excellence en santé et en services sociaux

Centre hospitalier de l'Université de Montréal (CHUM)

Centre hospitalier universitaire Sainte-Justine (CHU Sainte-Justine)

Centre hospitalier universitaire de Québec (CHUQ)

Centre hospitalier universitaire de Sherbrooke (CHUS)

Centre universitaire de santé McGill (CUSM)

Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)

Consortium en évaluation des technologies et des modes d'intervention en santé et services sociaux en première ligne (CETMISSS-PL)

Institut de réadaptation en déficience physique de Québec (IRDPQ)




Health Quality Council


Links to Third Party Sites

This website contains links to third party websites. These links are provided solely for your convenience and reference, and do not constitute an endorsement by MedStrategis. MedStrategis can neither be held responsible for nor guarantee the accuracy of the information or material in third party sites. Anyone using the links does so at their own risk.



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