10. Roadmap of the Submission Process of a Clinical Trial

10.1 Clinical Trial with Investigational Medicinal Product

The Canadian Association of Professionals in Regulatory Affairs has collated Health Canada’s proposed modernization of its regulatory framework for clinical trials, described in the following schematic illustration.

The areas which Health Canada proposes to modernize are described in Figure 2 below.

Table 1 below elaborates on the Categories of trials that would not require authorization once Health Canada assumes a risk-based approach.

https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16

10.2 Pediatric Investigation Plan

Health Canada has launched a voluntary policy pilot encouraging sponsors to submit pediatric studies for drugs that have already been approved for adults. This initiative which began on February 26, 2024, and will continue for at least two years, applies to new drug submissions and supplements to a new drug submission for any: new indication, new dosage form, or new route of administration. Below are some key points about the Canadian Pediatric Development Plan (C-PDP):

1. Scope: Sponsors who do not have an initial pediatric study plan (iPSP) or a pediatric investigation plan (EU-PIP) can participate in the policy pilot by including a Canadian Pediatric Development Plan (C-PDP) with their submissions. The C-PDP should be relevant to the drug and within the scope of this guidance.
2. Content: The C-PDP should provide details of any ongoing or planned pediatric studies. Sponsors are encouraged to consider the needs of all pediatric populations, including neonates, when developing their plans. Additionally, they may propose studying the potential therapeutic benefits of the drug’s active ingredient in pediatric populations beyond existing and proposed adult indications.
3. Submission Requirements: The C-PDP should include information such as the drug’s brand name, proper/common name, dosage form, therapeutic classification, approved indication(s), proposed indication(s), age groups for which studies will be undertaken, and control numbers for any previous submissions related to the C-PDP.
4. References: All data sources should be supported by references included with the submission. Sponsors are encouraged to review relevant guidelines issued by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other foreign regulators.

10.3 Clinical Study (Interventional or Observational)

Please refer to Section 10.1 above. The determination of whether a study requires regulatory authorization will depend on its scope and the category into which it may fall.