How does Health Canada’s Clinical Trial Application process compare to the USA and EU?
HOW DOES HEALTH CANADA’S CLINICAL TRIAL APPLICATION PROCESS COMPARE TO THE SUBMISSION PROCESSES IN THE US OR EU?
When the process is properly understood and the sponsor or the representatives have established contacts with Health Canada, the clinical trial application in Canada is relatively simple and so is the review process. The actual submission structure is also simple, and the content requirements are actually less than in the US and Europe.
There are no non-clinical, nor clinical study reports needed in the clinical trial application. What is needed is the administrative documents plus key scientific documents, which are the protocol, the informed consent form and the investigators brochure. There’s two Canadian specific templates required that we need to generate: the protocol summary as well as the overall quality summary. All of these are quite easy to prepare.
The review process is also efficient. A 30-day default review period applies. If questions are raised during the dossier review a response must be provided within two calendar days (exceptions may apply). And by way of comparison, in Canada there is no clinical hold period like in the United States. The review period is always 30 days, whereas in some European countries the review period can be as long as 60 days or more, and in the US it can vary.
Due to the standard 30-day review period in Canada, I believe it does facilitate the ethics review submission planning, which speeds up clinical trial start times. Also, there are efficient clinical trials start-up experts in Canada that can help with streamlining the study start-up process in parallel or after the clinical trials application approval.
Are Health Canada’s safety policies and guidelines more stringent than those imposed by the FDA?
The requirements are similar in Canada and in the U.S. for clinical trial applications as well as for post-approval initiatives.
For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.
With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.
Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.