The Therapeutic Product Directorate (TPD) is Canada’s federal authority responsible for regulations of prescription drugs and medical devices for human use. In order to sell a prescription drug or medical device 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 seven operational directorate under the Health Products and Food Branch, a branch of Health Canada. There are 12 offices and bureaus under TPD that are responsible for regulating the products as well as the analysis of Regulatory affairs pertaining to them within the country.

What does the TPD do?

  • Evaluates the safety, efficacy, and quality of a prescription drug or a medical device by reviewing the scientific information related to it
  • Examines the potential risks of the prescription drug or a medical device 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, TPD ensures that the non-marketed drugs and medical devices 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

Are you planning to market a product in Canada? Make sure you are aligned with the requirements of TPD. Contact Regulatory experts to know more about TPD pre-requisites at sales@freyrsolutions.com