The Therapeutic Product Directorate (TPD) is Canada’s federal authority responsible for regulations of prescription drugs for human use. In order to sell a prescription drug in Canada, scientific evidence for the product must be obtained from the directorate, as per the Food and Drug Regulations. It is a part of the Ten operational directorate under the Health Products and Food Branch, a branch of Health Canada. There are nine (9) offices and bureaus under the TPD that are responsible for regulating the products, as well as analyzing the Regulatory affairs pertaining to them within the country.

What Does the TPD Do?

  • Evaluates the safety, efficacy and quality of a prescription drug by reviewing the scientific information related to it
  • Examines the potential risks of the prescription drug and the risks associated with them
  • Reviews clinical trial applications for prescription drugs and investigational testing applications
  • In case of failure or unavailability of conventional therapies, the TPD ensures that the non-marketed drugs are available to the health professionals
  • Helps residents of Canada to make well-informed decisions by providing scientific medical information
  • Reviews adverse reaction reports ensuring the safety of the drugs under development

Would you like to gain more insights on the role of TPD and its Regulatory obligations? Consult a regional Regulatory expert like Freyr.