ARCHIVED - Laboratory Research and Testing

Health Canada undertakes the following laboratory activities devoted to supporting evidence-based regulatory decision-making regarding the review and testing of biotechnology-based biologics (including gene therapies):

• Research, both basic and evaluation-related; and
• Product testing.

The research and testing activities help ensure that biotechnology-based biologics are efficacious, pose minimized risk to Canadians and are of high quality.

Research Activities

The laboratory research conducted is designed to:

• Provide a better understanding of the methods used in assuring the quality of biotechnology-derived biologics;
• Develop new testing methods and techniques for the regulatory process
• Gain more knowledge about how different classes of biotechnology-based biologics work; and
• Generate credible scientific evidence to support effective decision-making.

Read more about the Biologics Research Program.

Product Evaluation Activities

In these laboratories, we undertake a variety of activities related to product evaluation. An important safeguard for Canadians is that we test batches (called "lots") of biotechnology-based biologics, before they are "released" for sale in Canada. Tests are done in both pre- and post-market stages of the product life cycle. We also test products to ensure the consistency of manufacturing as part of the approval process for new products; and engage in collaborative studies with other national and international organisations to establish methodology and standards to support testing activities internationally.

Biologics require different regulatory oversight than drugs made from chemicals. In addition to being sensitive to a variety of factors, including storage, handling, and temperature changes, they are also sensitive to variations in source materials and manufacturing processes. This means it is more difficult to ensure that biological health products are consistent from one lot to the next. Lot release testing is an extra check on the quality of these products.

Each lot of a Schedule D (biologic) drug is subject to the Lot Release Program before being authorized for market in Canada. The risk-based Lot Release Program covers both pre- and post-market stages. Products are assigned to one of four Evaluation Groups, with each group having different levels of regulatory supervision (testing and/or protocol review) based on the degree of risk associated with the product. This approach to testing and supervision allows Health Canada to focus ongoing testing on products for which greater surveillance is required such as vaccines and blood products. The criteria used to determine the appropriate Evaluation Group include, but are not limited to, the nature of the product, the target population, the lot testing history in Health Canada, and the manufacturer's production and testing history.

Read more about the Lot Release Program for Biologics in Guidance for Sponsors. This document explains how the Program works. It also outlines the extent of testing of biologics prior to their release for sale in Canada.

Related Information

We also operate a Laboratory Programme which focusses more on pharmaceutical health products as part of our national Compliance and Enforcement program.