Proposals to Amend the Food and Drug Regulations with respect to radiopharmaceuticals

September 20, 2011

Dear stakeholders,

Health Canada is considering two regulatory amendments which may be of interest to your organization. This letter is meant to inform you about the status of these two regulatory proposals as well as to solicit feedback from your members.

In February 2006, the Health Products and Food Branch brought in interim measures to address the use of positron emitting radiopharmaceuticals (PERs) in basic research studies. The intent of the 2006 interim compliance policy and guidance document was to address stakeholder concerns surrounding the requirement to file clinical trial applications, as per Division 5 of Part C of the Food and Drug Regulations until appropriate regulatory amendments could be made.

Proposed changes to the Food and Drug Regulations regarding the use of PERs in basic research were initially published in  Canada Gazette, Part I, in March 2009. Due to unforeseen circumstances, the regulatory proposal was stalled and we are now in the process of re-submitting for publication in Canada Gazette, Part I. The comments submitted during that consultation phase were taken into account and incorporated into this new proposal.

The absence of drug identification numbers (DINs) assigned to radiopharmaceuticals has made the tracking of the market status of these products difficult. Therefore, the second proposal would remove the exemption for radiopharmaceuticals from the DIN requirements. It would also outline new labelling requirements for radiopharmaceuticals such as replacing the Establishment License number on labels with the DIN. To this effect, a Notice of Intent was published on July 28, 2007 in Canada Gazette, Part I with a 30-day comment period. There would be a phase-in period of one year after these amendments are enacted during which time manufacturers would file their applications for DINs for their currently marketed products as well as update their labels in order to comply with the proposed requirements.

We intend to publish both proposed regulatory amendments in Canada Gazette, Part I, sometime in Fall 2011. In advance of the publication, we invite your input in the following areas:

1. In your opinion, would minor changes in radiopharmaceutical labelling pose any undue burden on your organization?
2. Do you have additional comments concerning the regulatory proposal for the use of PERs in basic research studies?

Your responses will be reviewed and considered in the development of the proposed regulatory amendments. Please forward your responses, preferably in electronic format, within 30 days from the date of this letter to:

• Office of Policy and International Collaboration
  Biologics and Genetic Therapies Directorate
  Health Products and Food Branch
  Health Canada
  Building 7, Tunney's Pasture
  Ottawa, ON K1A 0K9
  Address Locator: 0702B
• Fax number: (613) 952-5364
  Email address: BGTD.OPIC@hc-sc.gc.ca

Thank you in advance for playing an active role in these important regulatory projects. We are committed to keeping you updated as these initiatives develop.

Yours sincerely,

Original signed by:

Elwyn Griffiths
Director General