On May 21st, the NHPD released the Quarterly snapshot for Q4 indicating more streamlined review, aided by the release of new monographs.
Readers of dicentra’s Regulatory Updates will know that the NHPD has been focussing its activities in the product licensing area on developing pre-cleared information (PCI), including the publication of Monographs and Labelling Standards. The NHPD has also introduced a new 3-class system for reviewing Natural Health Product Licence Applications (PLAs). The three classes range from Class I(attesting to a single NHPD Monograph, and with an expected review time of 10 business days) to Class III (not supported by PCI; expected review time of 210 days). Read the full details of the 3-class system in dicentra’s Feb 9, 2014 Update.
The reason for the emphasis on the development of PCI and the 3-class review system is to improve NHPD’s performance times. It should be noted that since 2004, 84,918 product licence applications (PLAs) have been received, with 52,439 licences (NPNs) issued. That represents only 62% of applications making it through to licencing since the inception of the NHP Regulations. From the perspective of industry, this represents a failure rate of nearly 40%, which is unacceptably high.
Long-time observers of the NHP industry in Canada will know of the start-up problems at NHPD, which ultimately led to a backlog of several thousand unprocessed PLAs. This meant that manufacturers were selling non-compliant products through no fault of their own. At the same time other Associations were advising their customers not to distribute NHPs that were not licensed, leading to a sort of Catch-22 situation in the marketplace. As the regulator of the industry, NHPD needed to make some changes to bring some order to the market, and they hope to achieve this with the 3-class system relying on PLAs that mostly attest to PCI.
NHPD’s most recent Quarterly Results reflect this new direction. The latest report shows the number of applications completed exceeds the number received. This is an encouraging sign, as it means backlogged applications are being processed. Of particular note for this quarter are the type of PLAs received. The categories of Compendial, NHPD Labelling Standard, and TPD Category IV Labelling Standard are all up sharply, while the number of Homeopathic, Traditional and Non-Traditional applications have decreased significantly.
This quarter, NHPD finalized several new and revised Monographs, and several more are scheduled for publishing next quarter. This includes the revised Probiotic Monograph and the following new Monographs or Labelling Standards: N-acetyl-L-cysteine, Resveratrol, Red Wine Extract, Reishi, Multiple Ingredient Joint Health Products, Black Pepper, Seal Oil, Green Coffee Bean Extract, Ubiquinol, Triphala and Serrapeptase.
The following monographs are expected to be published for consultation next quarter: Spirulina, Black Walnut, Red Clover Isoflavones Extract, Cognitive Health Products and Royal Jelly, and revisions to Fluoride Containing Anticaries Products (addition of Potassium nitrate dental use and change of monograph name to Oral Health Products).
The release schedule shows steady progress by the NHPD in its aim of having more PCI for stakeholders to utilize.
The reliance on PCI is something that NHPD is pushing the NHP industry toward, and it can be advantageous, as it streamlines and expedites the submission process through facilitating faster and more consistent licensing decisions.
On the other hand, pushing competitors to rely on the same basic information in their applications for product licences also has a negative effect. If all companies attest to the same information in their PLAs, then the Canadian marketplace will end up with several products in any one category (Vitamin C, Echinacea, and so on) that have the same health claims, cautions and warnings, probably the same ingredients, and the only difference will be the brand name and graphics on the label. This in effect stifles innovation in industry, which will be a great shame. The NHP industry has always been in the forefront of innovation in the supplement category, and those of us involved certainly hope to see that continue.
Natural health product Consultant and FDA Consultant dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. When launching a product in Canada dicentra can assist you with determining whether your product meets the definition of a food or a natural health product and advise of the requirements and timelines for each category. dicentra can help your accelerated business growth by ensuring you have a clear-cut path to market and avoid costly reformulation or border issues before a non-compliant product is launched.
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