Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to

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The NHPD Monthly Communiqué is a publication of Health Canada s Natural Health Products Directorate (NHPD), the federal department responsible for the regulation of natural health products sold in

1 The NHPD Monthly Communiqué is a publication of Health Canada s Natural Health Products Directorate (NHPD), the federal department responsible for the regulation of natural health products sold in Canada. The communiqué is released to the Canadian public the first week of each month via the NHPD s electronic bulletin. Subscription to this e-bulletin is available at Questions or comments regarding the content of the NHPD Monthly Communiqué may be addressed to NHPD_DPSN@hc-sc.gc.ca. TABLE OF CONTENT: Each NHPD Monthly Communiqué is separated into five sections for ease of reference. These are: Product Licensing Information, Site Licensing Information, Compliance Corner, Clinical Trial Information and Other Information. PRODUCT LICENSING INFORMATION: New and Revised Natural Health Product Monographs P. 2 Product Licence Applications for Fish Oil Products P. 3 Upcoming release of the new PLA form and the Quality Overall Summary-Natural Health Products Template for Product Licence Applications (QOS-NHP-PLA) P. 4 SITE LICENSING INFORMATION: P. 4 COMPLIANCE CORNER: P. 4 CLINICAL TRIALS INFORMATION: P. 5 OTHER INFORMATION: P. 5 Page 1 of 5

2 PRODUCT LICENSING INFORMATION: New and Revised Natural Health Product Monographs Recognizing the important role monographs can play both in facilitating the review and processing of product licence applications and as reliable sources of product information for consumers, over the course of the next year, several new monographs will be added to the Compendium of Monographs. In addition, the majority of existing monographs will be revised and updated to reflect new research and evidence. Revised Monographs Revisions have recently been made to the monographs for Glucosamine, Hyssop and Cascara sagrada. The revised versions are currently available on-line in the Compendium of Monographs along with their previous versions, which have been archived for comparison purposes. 1. Revised Glucosamine Monograph: 2. Revised Hyssop Monograph: 3. Revised Cascara sagrada Monogprah: New Monographs The NHPD has recently completed two product category monographs for Corn and Callus Removers and Wart Removers. Product category monographs, as opposed to single ingredient NHP monographs, provide detailed information and guidelines for a wide range of products falling within a specific product category. Individuals and companies seeking approval to market these types of products may now attest to one of these monographs in their product licence applications. Those applications satisfying the criteria listed in the monograph will be processed within sixty (60) days. 1. Corn and Callus Remover Monograph: 2. Wart Remover Monograph: Page 2 of 5

Product Licence Applications for Fish Oil Products When submitting a product licence application for a fish oil product, unless the finished product contains only EPA (eicosapentaenoic acid) and/or

3 Product Licence Applications for Fish Oil Products When submitting a product licence application for a fish oil product, unless the finished product contains only EPA (eicosapentaenoic acid) and/or DHA (docosahexaenoic acid), applicants should indicate fish oil as the medicinal ingredient and present the pertinent medicinal ingredient information in the following manner: Column C and D of the PLA form: The proper and common name should be presented as "fish oil". Column H of the PLA form: If desired, EPA and DHA content in the fish oil can be expressed as potencies with their quantity in milligrams (mg) or percentage as an amount and "EPA" and "DHA" expressed as constituents. Column I Material of the PLA form: The source material for the medicinal ingredient should include the common name of all the fish used in the finished product (e.g. "sardine, mackerel oil," etc.). This applies in all cases. The following is a visual example of the current PLA form and illustrates how the information listed above should appear when presented to Health Canada. Upcoming monograph for fish oil products As indicated in the previous article, the Directorate will be publishing a number of revised and new monographs throughout the year. Among these will be a monograph for fish oil products. Page 3 of 5

4 Upcoming release of the new PLA form and the Quality Overall Summary-Natural Health Products Template for Product Licence Applications (QOS-NHP-PLA) The NHPD will be launching a new and improved Product Licence Application (PLA) Form. The content of the new PLA form is essentially the same as the previous; however, the revisions include an improved format and a numbered user guide for quick and easy reference to definitions and instructions linked to each field of the form. The NHPD anticipates making this form available online in spring 2006 for immediate use by all product licence applicants. That being said, the Directorate will continue to accept applications using the current form for a short transition period to be confirmed at a later date. In addition to the new PLA form, this spring will also see the release of the Quality Overall Summary for Natural Health Products Template (QOS-NHP-PLA). This brand new template will be available to applicants who must submit product quality information as part of their product licence application. The template will include the NHP Finished Product Specifications Template that contains the quality parameters (Identity, Purity, Quantity, and Potency), the corresponding NHPD tolerance limits and acceptable test methods as well as a numbered user guide for quick and easy reference to definitions and instructions linked to each field of the template. Medicinal ingredient specifications for isolates, synthetic duplicates, standardized extracts and probiotics will also be included with the template. The introduction of these two new forms will benefit both the NHPD and the applicant by leading to a more timely review resulting in a quicker decision made by the NHPD. SITE LICENSING INFORMATION: As indicated in our last communiqué, a full review of all guidance documents and forms is currently underway. The Directorate is also updating and refining its internal review processes and procedures, including those for site licensing and good manufacturing practices (GMPs). Significant progress has been made in this area and new and improved GMPs will be released within the next few weeks. A special communiqué outlining the revised GMPs will be published once they have been officially incorporated into daily practice. COMPLIANCE CORNER: To learn more about Health Canada s compliance approach for natural health products, please refer to the Compliance Policy for Natural Health Products. You may also wish to read the December 2005 issue of the NHPD Monthly Communiqué. Page 4 of 5

5 CLINICAL TRIAL INFORMATION: To learn more about clinical trials for natural health products, please refer to the following guidance document: Clinical Trials for Natural Health Products. OTHER INFORMATION: Page 5 of 5

Natural Health Products Directorate (NHPD) Clinical Trial Application and Attestation for Instructions with Sunnybrook specifics

Natural Health Products Directorate (NHPD) Clinical Trial Application and Attestation for Instructions with Sunnybrook specifics Appendix 4: Clinical Trial Application and Attestation Form Instructions Instruction sheet can be found online under Forms. The Clinical Trial Application and Attestation Form has 7 parts: Part 1: Applicant