Biologics and Genetic Therapies Directorate
Building #6, Tunney’s Pasture
OTTAWA, Ontario
K1A 0L2
June 10, 2002
To Associations:
Subject: Regulatory Policy for Positron-Emitting Radiopharmaceuticals-Draft Issue Analysis
The purpose of this note is to inform you that a draft Issue Analysis Summary on the regulation of Positron-Emitting Radiopharmaceuticals is available for comment.
Positron-emitting radiopharmaceuticals (PERs) are required for Positron Emission Tomography (PET), an imaging technology used to study bodily functions. In PET imaging, the PER is injected into the blood stream of, or inhaled by, a human. The person is positioned inside a special camera that tracks the course of the PER in the body, thus providing information about cellular metabolism and function in normal or diseased states. The PERs most commonly used with PET decay very rapidly (physical half-life is typically minutes to <2 hours), and require administration to a subject shortly following synthesis. PERs and PET have been used in Canada for the research and study of bodily functions, but their introduction into routine clinical use as a diagnostic tool has not yet been realized partly because there are no approved PERs for sale for PET imaging in Canada.
There currently is a framework in place for the regulation of radiopharmaceuticals. Similar to other radiopharmaceuticals, the sale or use of PERs in respect of a claim such as, but not limited to, the diagnosis, treatment, mitigation or prevention of a disease in humans, is enforced by the Food and Drugs Act and its associated Regulations. A Working Group was formed by the Biologics and Genetic Therapies Directorate to assess the flexibility of the current regulatory framework and analyse its suitability with respect to PERs, given some of the unique characteristics of PERs in relation to other radiopharmaceuticals.
The accompanying Draft Issue Analysis Summary has been prepared by the Working Group and reflects options available with respect to regulatory policy for PERs in Canada. This Issue Analysis is available as a draft for comment only. Changes to this document will be made on the basis of comments received from both external and internal parties.
Comments on this draft Issue Analysis Summary should be forwarded to:
Greg Monsour
Policy and Promotion Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate
Health Canada
Address Locator 3104A2
1600 Scott St
Ottawa, Ontario
K1A 1B6
Internet: greg_monsour@hc-sc.gc.ca
Phone: (613) 957-4241
Fax: (613) 952-5364
Yours sincerely,
Julia Hill
Associate Director General |
