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

 

Registration  

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    

 

ClinicalTrials.gov

 

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)

 

Databases

Disease Information

Data Reporting 


CADTH Search


Cochrane Library


NICE Clinical Knowledge Summaries

   

NLM Gateway

 

PubMed/Medline

 

 

Centers for Disease Control and Prevention

 

Merck Manual          

 

MedlinePlus.gov 



 


Impact factor

 

Key reporting guidelines EQUATOR Network

 

PubMed Central Journal List

 

Dictionaries & Glossaries

Statistics 

Clinical Practice Guidelines


Glossary - Medical Council of Canada

 

HTA Glossary_En

 

Language Portal of Canada

 

MedDRA

 

MeSH

 

 

 


 


Databank of Official Statistics on Québec

 

St@tRAMQ

 

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)

 

Jurisdiction

Formulary Drug Listings 

Submission Requirements

Health Technology Assessments & Recommendations

National

Common Drug Review

www.DrugCoverage.ca

 

Common Drug Review

The pan-Canadian Oncology Drug Review (pCODR)

CADTH/ACMTS Health Technology Assessments

CEDAC/CCCEM Recommendations 

Alberta

Health & Wellness Drug Benefit List

 

Alberta

 

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

Manitoba

Drug Interchangeability Formulary Regulation

Manitoba

Manitoba Centre for Health Policy

New Brunswick

Prescription Drug Program Formulary

Atlantic Common Drug Review

Horizon Health Network

Nova Scotia

Formulary

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

Ontario

Drug Benefit Formulary

 

Ontario

 

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

Québec

Liste des médicaments assurés

 

Québec

 

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)

Saskatchewan

Formulary

Saskatchewan

Health Quality Council

 


Links to Third Party Sites

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