The goal of drug development is to assess the value of innovative approaches to the treatment of diseases and disabilities. However, medicines have the potential for untoward effects and not all patients respond in exactly the same way to every medicine. Consequently, quality starts in the drug development phase and continues throughout the clinical use of an approved product.
First, the drug product(s) under investigation must consistently meet required standards such as those for purity, potency, packaging and stability testing.
The second stage of quality involves investigating the drug product(s) through the design and completion of studies specific to the treatment under examination. Such studies are carefully controlled and are conducted within established norms including those for the practice of medicine, research ethics in humans, and the Food and Drugs Act of Canada.
A successful development program ultimately results in a particular approach to drug treatment receiving a Notice of Compliance from Health Canada. As such the treatment can be made available to Canadians. Typically, new drug treatments are designated as prescription products and official labelling directs health care professionals when using the new treatment for individual patients with a particular medical need.