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Canada: NHPD Quarterly Report Released

The Natural Health Products Directorate (NHPD) of Health Canada has issued its latest Quarterly Report (Fall 2005 / Winter 2006), available online at:

Highlights of the Report include statistics regarding current throughput and activities, strategic and operational initiatives including the Directorate's Business Improvement Initiative, and a general indication of status.

Milsetones achieved during the quarter include the Directorate's issuance of its 200th site licence, its 1000th product licence and the elimination of its clinical trials backlog. Specifically, the Directorate notes that it is currently receiving 28 new product and/or site licence applications a day and manages to issue roughly 6 licences per day while an additional 2 applications are withdrawn. The current backlog is over 12,000 applications leading NHPD to state "under present conditions, (it) cannot effectively manage the flow of incoming vs. outgoing."

The Directorate's Business Improvement Initiative intends to: eliminate the current backlog; streamline the submission review process (to ensure optimal productivity and avoid future backlogs), bring the Directorate's production to 60 product licenses and 12 site licenses issued per day.

NHPD exepects to be at over 120 full-time employess by the end of the fiscal year, and also intends to bring the number of NHP monographs to 300 from the current 86 by December 2006. It also anticipates possible modifications and amendments to the Regulations, and to all guidance documents and forms by summer 2006.

In a policy announcement, NHPD observes that it "can no longer afford to accept poor quality applications- all incomplete submissions are being returned."

The Natural Health Products Directorate has received a total of 12129 product and site licence applications since January 1, 2004. Since then, 1602 product and site licences have been issued.

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