Health Canada
Santé Canada
Biologics and Genetic Therapies Directorate
Building #6, Tunney's Pasture
Postal Locator: 0603D
OTTAWA, Ontario
K1A OL2
02-110025-953
July 3, 2002
To: Stakeholders
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 Q 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 analyze 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 must be
received by August 28, 2002 and should be directed 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
Acting Director General |
