Variations in the drug development and approval processes across different countries can impact the availability of therapies for patients. A comparative analysis of data between 2002 and 2016 (Rawson, 2018) found that new drugs were often submitted for approval to the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) prior to seeking Health Canada (HC) approval. However, HC is a major global regulatory authority, the requirements of which sponsors should consider when aiming to bring a new medication to market.
As in any country, the drug development and drug approval process in Canada is a long and complex process that requires a significant investment of time, effort, and resources. Although navigating the regulatory submission requirements in Canada for clinical drug trials can be a daunting task, it is essential for ensuring the success of the trial and the eventual approval of a drug in Canada.
Health Canada’s Role in Regulating Clinical Drug Trials
HC is a federal department responsible for ensuring the safety and efficacy of drugs, medical devices, and other health products by strictly regulating clinical drug trials conducted in Canada. This agency’s regulatory requirements for clinical drug trials are designed to protect the health and safety of trial participants, ensure the integrity of trial data, and provide evidence of a drug’s safety and efficacy.
In addition to reviewing and approving clinical trial applications (CTAs), HC also monitors ongoing trials for compliance with regulatory requirements. These requirements for drug studies include the submission of a detailed clinical trial protocol, informed consent forms for trial participants, and regular reporting of trial data to the department.
Types of Clinical Drug Trials and Their Regulatory Requirements
There are several types of clinical drug trials, each with its own regulatory requirements. Phase I trials, which are typically conducted in healthy volunteers, focus on assessing the safety of a drug and require a detailed clinical trial protocol and informed consent forms. Phase II and phase III trials, which involve larger numbers of patients and assess the efficacy of a drug, require additional documentation, including a detailed statistical analysis plan and a clinical trial report. Even after a drug is approved and sold on the market, monitoring by HC will often continue through phase IV studies to collect long-term usage, safety, and efficacy data; unlike phase I-III trials, these trials do not need to be submitted under a CTA, unless otherwise requested by HC.
Clinical Drug Trial Application and Approval Process
The first step of the clinical drug trial application process in Canada involves submitting the Canadian CTA dossier, which typically includes administrative forms, a detailed study protocol, the protocol summary in HC’s template, the Informed Consent Form, and Investigator’s Brochure (IB). Once a CTA is submitted, there is a 30-day default review period from the date of receipt by HC’s review team who may request additional information or clarification before approving the trial to proceed. Once a clinical trial is authorized, the NOL is issued to the sponsor, permitting them to begin study activities in Canada.
Once all required data demonstrates a drug’s potential therapeutic benefit outweighs its potential risks, the sponsor can then file a New Drug Submission (NDS) to HC. This must include all results of the quality, preclinical, and clinical studies, whether conducted in Canada or not. As HC reviews all provided safety and efficacy data, a risk/benefit analysis is conducted prior to reaching their approval decision on a new drug. The NDS review process can range from 7 months for an accelerated application to approximately 1 year for standard submissions.
Ethical Considerations and Review Process
In addition to regulatory requirements, clinical drug trials in Canada must also comply with ethical considerations and undergo an ethical review process. The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS-2) provides guidelines for the ethical conduct of clinical drug trials, including informed consent, confidentiality, and privacy. Additionally, clinical drug trials must undergo review by the Health Canada Public Health Agency of Canada (HC-PHAC) research ethics board (REB) to ensure compliance with ethical guidelines.
Post-Approval Requirements and Monitoring
Once a clinical drug trial is approved, the sponsor must comply with ongoing post-approval requirements and monitoring. This includes regular reporting of trial data to HC, compliance with regulatory requirements, and ongoing monitoring of trial participants for adverse events or side effects. Sponsors must also report any changes to the protocol or clinical drug supplies in the form of an amendment (CTA-A), as well as other updates such as IB changes or premature trial discontinuation decisions.
Importance of Understanding Regulatory Requirements for Success
By following the regulatory requirements and ethical guidelines for clinical drug trials, sponsors can ensure the success of their trials and contribute to the development of safe and effective drugs for the Canadian population. Although navigating the regulatory submission requirements for clinical drug trials in Canada is a complex process, sponsors can rely on a global contract research organization’s (CRO’s) trained team of regulatory experts to remain compliant with Health Canada regulations.
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