Resource Library

    Canadian Drug Regulatory Guides

    eGuide - Overcoming Obstacles in the Canadian Drug Approval Process

    eGuide - Drug Review & Approval Process in Canada

    Infographic - Drug Review & Approval Process in Canada

    Drug Regulatory Articles

    About the Drug Regulatory Process in Canada

    New Drug Submission Process in Canada

    How to Determine your Regulatory Affairs Needs

    How long does it take a drug product to be approved in Canada?

    The Ultimate Glossary of Drug Regulatory Terms for Canada

    Celebrating 25 year anniversary in Regulatory Affairs

    Overcoming Obstacles in the Drug Approval Process in Canada

    The Drug Regulatory & Approval Process in Canada - FAQ

    Myths of clinical trial and drug approval process in Canada

    About Working with Regulatory Experts

    Celebrating 25 year anniversary in Regulatory Affairs

    How to Pick a Drug Regulatory Affairs Consultant

    Top Traits of an Excellent Drug Regulatory Affairs Consultant

    The importance of working with Canadian Regulatory Consultants

    About Health Canada Regulations

    New Drug Submission Process in Canada

    Are separate Clinical Trial Applications required for each protocol?

    Does Health Canada require all documents be translated to French?

    Are Sponsors required to have a legal representative reside in Canada?

    Notice of Compliance with Conditions versus Priority Review

    Clinical Trial Site Information Forms - a Health Canada update

    What adjustments are made for Targeted Therapeutics?

    Will Health Canada approve Trials with multiple investigational products?

    Does Health Canada prefer early phase or late phase trials?

    Why does Health Canada ask for Foreign Reviews?

    Health Canada news on formatting of regulatory submissions

    Does Health Canada give approvals based on foreign decisions?

    Health Canada issues a new guidance GUI-0064

    What is a Drug Identification Number?

    Are drug labels to be submitted during the Clinical Trial Application?

    About Canada as a Clinical Trials Destination

    How does Canada's Application process compare to USA and EU?

    Has Regulatory Affairs in Canada changed from a decade ago?

    How does Canada rank as a country for conducting Clinical Trials?

    What type of Market Protection exists for new Drugs in Canada?

    Looking for something specific?

    Contact our Regulatory Experts

    Free Download – In this guide, you will learn what we have encountered as the most common obstacles in the Canadian Drug Market Access industry and how to side-step or overcome them.

    Read this guide before you start the regulatory approval process in Canada. SPharm will help turn a seemingly complex or intimidating regulatory approval process into a more manageable and predictable one.