The importance of working with Canadian Regulatory Consultants

The Importance of working with Canadian regulatory experts.

 

WHY IS IT IMPORTANT TO WORK WITH EXPERTS IN CANADIAN REGULATORY AFFAIRS?

Having a Canadian regulatory expert is important to facilitate the global Canadian submission process and all post-approval activities. It’s also important to know that Health Canada prefers speaking with individuals that understand the Canadian medical as well as regulatory environment, whether they are the sponsors or their representatives. The support of a Canadian regulatory consultant is key for the submission of clinical trial applications, New Drug Submissions, or other regulatory initiatives. But it is most important for the global product development strategy, particularly when dealing with niche products used for treating orphan or life-threatening diseases. By understanding Canadian as well as foreign regulatory environments, a Canadian consultant can provide the best strategic initiative for timely access to the Canadian market, keeping the global regulatory initiatives in mind.

The regulatory paths for market access in Canada are essentially threefold. First there is the standard regulatory new drug submission path, then there is the notice of compliance with conditions (NOC/c) path, usually applicable for oncology or other niche products, and finally there is the priority review path. The latest two have shorter review standards at Health Canada.

 


 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 



2021 Covid-19 Vaccines Update

2021 Covid-19 Vaccines Update

In December we published a report on up and coming Covid-19 Vaccines from around the world. This month we are publishing an update on approved Covid 19 Vaccines and promising Covid-19 Vaccine candidates that have reached phase 3 clinical trials. We have indicated background information, Trial Design, their status for each.


This report is co-published with the Clinical Research Consultancy CRO, McDougall Scientific and provided to you in a format that is hopefully useful to digest. All clinical trial data, summaries, content and references have been referenced directly from clinicaltrials.gov provided by the National Institutes of Health, by the Regulatory Affairs Professionals Society (RAPS),  the New York Times Coronavirus Vaccine Tracker, and by CNN Health.

Download the 2021 Covid-19 Vaccines report

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