I am writing to share some helpful information on Canadian regulatory obstacles for natural health products (NHPs). The Natural Health Products Directorate (NHPD) is at a fundamental crossroads in their coming of age. I do not want to raise an alarm, though there are indeed some potentially drastic changes in regulatory development right now, which demand your attention.

First, the NHPD still has an enormous backlog of NHP applications. In the early months of this quarter, the NHPD began initiating their "Early IRN" system requests for more information, sent out to applicants. The NHPD has developed software to send these out in a semi-automated fashion, and has issued over 6,000 of these since the new year began. The NHPD says they are offering applicants "early feedback" as their justification, saying they are trying to improve the quality of their backlog.

In reality, the NHPD is operating under a serious myopia. Regardless of their alleged motives, the end result is staggeringly uncompromising. Today, the NHPD is rejecting 62 percent of all licence submissions for NHPs compared to a mere 55 percent last year. They have also run into a serious wall: the novel combination products. Their licensing stats are seriously down this past quarter. Their NPN output per day is down nearly by half compared to 2008. They are slowing down, because their workload is getting harder.

The NHPD has committed to working through the backlog by April 30, 2010. This is the end of their fiscal year for 2009-2010. This also marks the end of their current funding for the backlog. Their self-interest as an organization is to meet that goal in the most efficient manner.

If you receive an IRN which is non-specific in its requests, this is an E-IRN. Respond to it. Do not let your submissions die down. The NHPD is in a high state of flux right now - and the worst thing we can do is call it quits. An E-IRN probably only means you need to submit more full text articles to the NHPD, not redo your entire submission. If your submission fails for whatever reason, resubmit. A safe product should never be prevented from market access when its claims are based on truth.

The current situation calls for your vigilance, but also your patience. Many of us are taking action behind the scenes to effect political and regulatory change, but this takes some time. Expect great change this year. But for the time being, it is paramount that your current submissions are maintained sufficiently to keep them in queue. The backlog is our greatest asset in negotiating change with the Minister's office.

We are working diligently to keep submissions in queue. So long as the NHPD has a backlog (in our terminology, not theirs), review fees cannot be installed. And we must keep our submissions in queue until we get what we want - our claims, our formulations, our products.

The NHPD thinks they are doing a tremendous job. We must remind them with our diligence that they certainly are not. We need to increase their learning curve.

Brian Thomas Wagner, President

NHP Consulting Inc.

phone (250) 590-3795

email  brian.wagner@nhpc-research.com

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