Biologics, Radiopharmaceuticals and Genetic Therapies
Before a biologic can be considered for approval, sufficient scientific evidence must be collected to show that it is safe, efficacious and of suitable quality. Biologics differ from other drugs for human use in that they must - in addition to the information required for other drugs - include more detailed chemistry and manufacturing information. This is necessary to help ensure the purity and quality of the product, for example to help ensure that it is not contaminated by an undesired microorganism or by another biologic.
As part of the New Drug Submission process, biologic manufacturers must also supply Product Specific Facility Information that outlines the method of manufacture of the biologic in significant detail, since slight variations can result in a different final product. Further, an inspection of the manufacturing facility, known as an On-Site Evaluation (OSE), is completed to assess the production process and facility since these aspects also have a significant impact on the safety and efficacy of the product.
If there is sufficient evidence to support safety, efficacy or quality claims for a New Drug Submission (NDS) or a Supplement to a New Drug Submission(S/NDS), the product is issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) indicating that the biologic is approved for sale in Canada.
Biologics are then monitored by being placed on a lot release schedule tailored to their potential risk, manufacturing, testing and inspection history to date. With higher risk biologics, each lot is tested before being released for sale in Canada. Moderate risk biologics are periodically tested at the discretion of Health Canada while manufacturers of low risk biologics usually only need to contact Health Canada regarding lots being sold or for providing certification of complete and satisfactory testing. Products are carefully scrutinized before they are placed in any level of the lot release process, and at any time the testing regime for a biologic may be altered.
Health Canada, in collaboration with the Public Health Agency of Canada, also monitors biologic adverse events, investigates complaints and problem reports, maintains post approval surveillance, and manages recalls, as required.
Some examples of Biologics and Genetic Therapies include:
- Blood and blood products,
- Cells, tissues and organs, including xenografts (living cells, tissues and organs from animal sources),
- Gene therapies,
- Viral and bacterial vaccines,
- Therapeutic products produced through biotechnology, and
- Radiopharmaceuticals which include drugs either of chemical or biological origin which are intentionally made radioactive for the purpose of diagnosing illness, as well as kits that are used for the preparation of radiopharmaceutical and radionuclide generators. Radiopharmaceuticals are used as diagnostic or therapeutic agents and are always prepared and administered by health care professionals; they are never self-administered.
What Information Can You Find Here?
In this section, you can find links to the Food & Drugs Act and Food and Drug Regulations, an updated list of biologics and genetic therapies that have been granted a Notice of Compliance, research programs, news releases, proposals, reports, executive summaries, information kits and related Web sites. Biologic and genetic therapies manufacturers and establishments can find guidance documents, for example Good Clinical Practices, Good Laboratory Practices, and Good Manufacturing Practices.
Information about Biosimilars.
Information about nanotechnology-based health products and food.
The Progressive Licensing Project has been initiated to develop a drug regulatory system for the future, and gives details of the plan for developing a new framework, and provides an opportunity for discussion with Canadians regarding drug licensing.
For information on drugs approved for use in Canada you can access the Drug Product Database.
Find more information about biotechnology-based health products in the Science and Research section of our Web site.
Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device.
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