Guidance Policy - Use of Positron Emitting Radiopharmaceuticals (PERs) in Basic Research Policy (POL-0053)

(February 24, 2006)

Contact Name: Drug GMP Inspection Unit
Tel: 613-952-9319
Fax: 613-957-6709
E-Mail: GMP_Questions_BPF@hc-sc.gc.ca

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Health Products and Food Branch
Inspectorate
Graham Spry Building, 2^nd Floor
250 Lanark Avenue
Address Locator # 2002B
Ottawa, Ontario
K1A 0K9

February 24, 2006

06-103780-406

To: Associations

An amendment to Part C, Division 3 of the Food and Drug Regulations with respect to the use of positron emitting radiopharmaceuticals (PERs) in basic research has been initiated by Health Canada, in recognition of the fact that the application of the current regulations for clinical trials under Part C, Division 5 to PERs research studies is placing an undue regulatory burden on the researchers in this field and may be impeding basic research involving PERs in Canada. The proposed regulatory amendments will take into account the size and nature of the affected basic research community, the established safety profiles of some commonly used PERs, the models of review used by other competent regulators and, most importantly, assessment and management of the risk to which human research subjects are exposed.

In the interim period, a new compliance policy, entitled Use of Positron Emitting Radiopharmaceuticals in Basic Research, will be in effect. This policy is accompanied by the guidance document Factors Considered in the Assessment of Risks Involved in the Use of Positron Emitting Radiopharmaceuticals in Basic Research Involving Humans, which outlines the criteria under which the compliance policy will apply.

The compliance policy is now available on the Compliance & Enforcement website of Health Canada at the following address:
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/
drugs-drogues/docs/index-eng.php

The companion guidance document is available at the following address:
http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/
guides/index-eng.php

Inquiries about the compliance policy can be addressed to the Drug GMP Inspection Unit by telephone at (613) 952-9319, by fax at (613) 957-6709, or by e-mail at GMP_Questions_BPF@hc-sc.gc.ca

Original signed by

Diana Dowthwaite
A / Director General

Cover Page

Our Mandate:

To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Health Products and Food Branch Inspectorate

Guidance Policy

Use of Positron Emitting Radiopharmaceuticals
(PERs) in Basic Research

Policy-0053

Supersedes:
New document

Date issued:
February 24, 2006

Date of implementation:
February 24, 2006

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