The NHPD has recently released the finalized version of the “Quality of Natural Health Products Guide”, superceding the “Evidence for Quality of Finished Natural Health Products” after a 3 month open consultation period with industry. Increased flexibility in meeting the requirements is outlined in this guide – a great thing for industry.
The NHPD has recently released, on June 28th, 2013, their long-awaited sequel (six years in the making) to their “Evidence for Quality of Finished Natural Health Products” guidance document with the publication of the third version of the quality manual, named the “Quality of Natural Health Products Guide”. This updated Quality guidance document is effective immediately and applies to Sections 42-44 of the Natural Health Products Regulations. The guidance document for the Compendium of Monograph has also been revised to be consistent with the new NHP Quality Guide. To be consistent with the other branches of Health Canada, the NHPD is employing a risk-based approach where elements of quality relating to safety and efficacy are the most scrutinized.
The thematic shift of the updated NHP Quality Guide is in how the onus of responsibility for product has been moved from the government regulatory body of the NHPD to the license holder. It is the license holder’s responsibility to ensure that all quality information is documented, maintained, relevant, accurate and sufficient to support the quality of their NHPs and that the product specification are in accordance with those of the guidance document. All NHP submissions must include the most recent version of the Finished Product Specifications or attest meeting the sample specifications in the NHP Quality Guide. Since the Quality of Natural Health Products guidance document is effective immediately industry is tasked with the real-time implementation of the revised standards. In order to allow industry time to make the necessary changes the NHPD expects license holders to update their product specifications of their licensed products to comply with the changes to quality requirements within the next lot/batch or 12 months (whichever is sooner).
The major update in the “Quality of Natural Health Products” guidance document is the flexibility that the NHPD is willing to give in meeting their quality requirements. Though it describes specific requirements for producing NHPs to the high quality mandated the Regulations, the NHP Quality Guide permits substitutions, modifications or even exclusions of any of the requirements stated in the guidance, provided that scientific rationales are documented and maintained. The scientific rationales should be based on Good Manufacturing Practices (GMP), scientific principles, product history and experience. With the newly-offered flexibility in meeting the quality requirements of NHPs companies are no longer bound to the most restrictive testing and levels, provided that sound scientific rationales can justify not using those in the NHP Quality Guide. However, be aware that any documentation not requested at the time of the review can be requested by the NHPD at any time, so it is important to make sure your justification for specific testing methods (or lack thereof) are sound.
An in-depth knowledge of GMP, scientific principles and vast experience interacting with the NHPD and the information they request is paramount in utilizing this novel open quality approach. At dicentra, we understand the challenges you face in having your products undergo a myriad of testing in order to fulfill the quality requirements in the Regulations. Our team of quality and compliance staff has the knowledge and expertise to ensure solely the relevant testing appropriate for your product is performed with the least restrictive acceptable tolerance limits.
With the revisions to the quality guidance document, previously-licensed NHPs can be reexamined for potential wider limits or even reduced testing. Please contact us at 1-866-647-3279 or info@dicentra to learn more about the services we can offer in supporting the quality of your product in face of regulatory scrutiny.