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Clinical Trial Applications

Clinical Trial Applications - Getting Health Canada Authorization

If you intend to conduct clinical trials in Canada with a pharmaceutical, a biologic or a radiopharmaceutical drug, you must prepare and submit a Clinical Trial Application (CTA) to Health Canada, which includes the required paperwork for review by Health Canada for the purpose of obtaining authorization to proceed with your clinical trial.

  • It will take Health Canada as little as 30 days to review (target review)
  • Sponsors have two days to respond to questions from Health Canada. This to secure their efficient 30-day review target; exceptions may apply.

The global development process can be both lengthy and complex because it involves in-depth research and key document preparation such as the Protocol, Investigator Brochure (IB), and Informed Consent Form (ICF), as well as some related summaries. It also requires rigorous regulatory submission preparation and submission to the regulatory authorities. 


The CTA Process with SPharm – from complex to streamlined

As Regulatory Affairs experts, SPharm is ideally suited to handle the CTA process required by Health Canada as well as its Investigational New Drug (IND) application equivalent at the Food and Drug Administration (FDA) in the United States.

Our experienced and highly regarded team can help make the regulatory process relatively straight forward, less timely and more cost efficient. We are trusted to navigate and prepare CTAs because our team of experts delivers on the following:

  • It can take SPharm as little as two weeks to prepare a dossier for submission, when all needed information is at hand
  • SPharm streamlines the CTA process and has a long-standing history of increasing the probability of obtaining a CTA authorization by Health Canada
  • Provide timely information and insight on regulatory requirements & develop short and long-term regulatory strategies with market access in mind
  • Provide regulatory guidance in protocol preparation and study design
  • Participate in preparation of Investigator’s Brochure & Informed Consent Forms
  • Liaise with experts as needed
  • Coordinate Pre-CTA Meeting when needed and prepare related minutes
  • Prepare complete CTAs
  • Prepare eCTD or non-eCTD electronic-only publications, and secure submissions
  • Ensure study regulatory lifecycle management

Please review our guide on the regulatory process in Canada for further insight into the requirements.

Clinical Trial Applications in Canada

In Canada, the federal department responsible for the country’s public health is Health Canada (HC). It is the regulatory body in charge of ensuring that clinical studies adhere to the strictest safety and efficacy requirements. Its goal is helping Canadians maintain and improve their health, while respecting individual choices and circumstances.

The Food and Drugs Act and the Food and Drug Regulations (the Regulations) govern the sale and importation of drugs for use in human clinical trials in Canada, specifically, Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects.

The CTA application process can involve multiple rounds of guidance, review and revision requiring patience and perseverance. 

SPharm is trusted by companies globally to drive the CTA process from start to authorizaton and regulatory lifecycle management of the study.

Find out what SPharm can do for you.

Learn how our proven expertise can help reach your objectives faster. Contact us today.