By: Ashleigh Hampton, MSc, Manager Scientific Affairs
March 19, 2012
The Natural Health Products Directorate (NHPD) released the Evidence for Safety and Efficacy of Finished Natural Health Products (NHPs) guidance document in December 2006. Since then, the NHPD has been gradually revising the criteria required to support the safety and efficacy of NHPs, but has not yet published the updated criteria.
While there has been no official revision to the Evidence for the Safety and Efficacy of Finished NHPs, dicentra’s scientific evaluators have been reviewing inconsistencies in NHPD correspondence to identify and inform our clients of the various changes in the NHPD’s review of the evidence. As such, we have adapted our review strategy accordingly to ensure our clients continue to receive high quality scientific and regulatory support.
In addition to the changes to the criteria for finished NHPs, we have observed differences in the way similar NHP applications are reviewed. We acknowledge that the opinions of one reviewer may not always be the opinions of another, but inconsistencies between reviews can make it challenging for the industry to compile high quality submissions.
Inconsistencies between NHPD reviewers may be the most obvious in the case of resubmissions. For example, you are looking to replace an expensive ingredient with a more cost effective one. If this new ingredient is of a different species or present in a different quantity, the NHPD will require that you resubmit the application. So you compile the application using the same evidence as was approved for the original ingredients and receive an Information Request Notice (IRN) requesting additional information which was not required for the previous approval. How can that be? This may be the result of reviewer inconsistency. Further to this, the previously accepted evidence may not be sufficient to support the efficacy and/or safety of the same product today which further demonstrates that changes to the standards of evidence for finished NHPs have occurred.
Recently, the NHPD has indicated that they are diligently working on trying to reduce the inconsistency between evaluations and publish the revisions to the evidence for Safety and Efficacy of Finished NHPs guidance document. In the meantime, dicentra can assist with the compilation of high quality submissions through the interpretation of the evidence to support the safety and efficacy of your NHPs.
dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com