Summary of the NHPD Report for Quarter 3 of 2012-2013

Health Canada’s Natural Health Products Directorate (NHPD) has published its Status of applications quarterly report for the 3rdQuarter (Q3) of the 2012-2013 fiscal year. The report provides statistical data on the product licence, site licence and clinical trial applications received and processed by the NHPD in Q3.

The NHPD reports dwindling numbers (n = 614) for product licence applications and amendments remaining from the pre-UPLAR era.

Interesting statistics on the product licence applications completed in Qshows a 19% refusal rate for all applications processed during this quarter. This is a threefold jump from the previous quarter. 61% of the refused applications failed to respond to NHPD requests for further information, while the rest did not meet the definition of an NHP (32%) or missed basic application requirements (5%). Non-Traditional product licence applications make up the overwhelming bulk of all product licence applications completed in Q3.

The NHPD has been proficient in meeting its performance targets of 60 days for pre-cleared information as well as the 30 day target for initial assessments. For products requiring full assessment, the 180 day target was met only 62 % of the time.

Statistics on site licencing show 36 applications and 136 renewal requests were completed. Clinical trial applications (CTAs) were, as usual, few and far between. Only 8 CTAs were received in the quarter.