Health Canada Response Letter to FDA on Proposed MOU Amendments
April 18 2008
Murray M. Lumpkin, M.D.
International and Special Programs
Department of Health and Human Services
Rockville, MD 20857
Dear Dr. Lumpkin:
I have the pleasure of replying to your proposal to adopt the following amendments to the Memorandum of Understanding Between the Food and Drug Administration, Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada Regarding Sharing and Exchange of Information About Therapeutic Products signed November 18,2003 (MOU), to include, among other things, foods and natural health products. It is understood that specific activities to be undertaken will be elaborated in work plans by our two organizations.
- The MOU Title is amended by deleting the last three words, “About Therapeutic Products.”
- The Preamble is replaced by an Introduction, which reads, “The Food and Drug Administration (USFDA), Department of Health and Human Services of the United States of America and the Health Products and Food Branch (HPFB), Health Canada of Canada (collectively “the Participants”) recognize the importance of timely and effective communication and collaboration between U.S. and Canadian governmental authorities. The Participants share a mutual high regard for the critical role of one another’s regulatory systems. Therefore, the Participants to this Memorandum of Understanding (MOU) intend to establish mechanisms by which the sharing and exchange of documents and/or information between staffs would be facilitated as decided by the Participants.”
- Section I. “Purpose” is amended by deleting the last nine words, “related to the regulation of the specified therapeutic products.”
- In Section II “Scope,” the first sentence of the first paragraph (chapeau) is amended to read, “This MOU covers products regulated by, and activities under the mandate of, both Participants.”
- In Section II “Scope,” the second sentence of the first paragraph is amended to read, “The Participants intend to develop specific procedures for the sharing and exchange of regulatory, safety, emergency management, and public health information related to these products and activities.”
- The word “therapeutic” is deleted everywhere it occurs in section II(A), (C), (D), (F), and (J).
- Section II(K) is amended by replacing the last four words, “substances and counterfeit drugs” with “substances, counterfeit drugs, and other areas of mutual interest.”
This reply and your letter constitute an amendment to the MOU effective on the date of receipt of this reply, and the attached consolidation, in English and French, reflecting these amendments, becomes the official text of the arrangement.
Assistant Deputy Minister
Signed Memorandum of Understanding (2003)