By Manushvi Chadha, BPharm, RA Cert
NHP, Cosmetic and Drug Regulatory Affairs Associate
As of June 2012 the Natural Health Product Directorate (NHPD) has released a document outlining their new approach to Natural Health Product (NHP) regulation. They define their “New approach” as achieving a balance between the consumer’s access / safety and industry innovation / growth
The NHPD has currently licensed over 50,000 NHPs and have committed to a deadline of February 2013 to clear the backlog of pending applications. With such a large database of submissions the NHPD has a wealth of information to reference when newer applications are received. This large volume of product information can be utilized to increase the NHPDs reviewing efficiency as they can look up the information on file for most ingredients.
Additionally, the NHPD has proposed to implement a “three class system” to determine the amount of time required to review a product licence application based on the level of certainty (i.e. how much is known about the product – pre cleared information (PCI)). By streamlining the product licence application process the NHPD proposes to drastically reduce product review times. With the aim to have 99% of products reviewed in 30 days or less – a marked difference to the timelines currently being followed.
| Class | Certainty | Information submitted | Previous Target | New Target |
| Class 1 | High level of certainty | Compendial / Pre cleared information – monographs, AbLS’ published by NHPD | 60 days | 10 days |
| Class 2 | Medium level of certainty | Pre cleared information + additional published literature(Amendments may fall under this category) | 180 days | 30 days |
| Class 3 | Low level of certainty | Clinical trial evidence and full pre-market assessment | 180 days | 180 days |
The NHPD expects the number of Class 3 applications to be significantly reduced due to the expansive PCI database that can be referenced thereby decreasing the time required for review. Additional steps the NHPD have taken to reduce the number of Class 3 products in queue are:
– Releasing, in May 2012, a new guidance document for NHP licensing. This document is currently open for consultation and will be finalized after Aug 21, 2012.
– Publishing the following eight new monographs for consultation:
The new targets will be a boon to the natural health products industry as it drastically reduces the waiting time for a NPN. This will be even more relevant after February 2013 when Exemption Numbers (ENs) are no longer in effect and industry will actually have to wait untill the receipt of their NPN to sell.
As the sunset date for Unprocessed Product Licence Applications (UPLAR) approaches, it appears that the NHPD are on track with their expectations and the industry will see a smooth transition into the new regulatory landscape that is on the horizon.
References:
“A new approach to natural health products”: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/nhp-new-nouvelle-psn-eng.php
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