The NHPD has introduced a new system for reviewing Natural Health Product (NHP) applications. Submissions are categorized into one of three classes with different review times based on level of certainty of knowledge. A monograph attestation form has also been introduced to expedite the review process.
In December 2013, the NHPD officially introduced a new three-class review system consistent with their “New Approach to Natural Health Products” that was initiated in 2012. This new three-class system (Classes I, II and III) categorizes NHPs based on the level of certainty of their ingredients. Each class has a different level of pre-market review and different review times.
The three classes are as follows:
Class I are NHPs attesting to a single NHPD Monograph. It has the highest level of certainty with an established safety and efficacy profile for the medicinal ingredient. It has the lowest level of pre-market review. This class has the shortest expected review time of 10 days.
Class II are NHPs attesting to multiple NHPD Monographs and whose safety and efficacy are supported by NHPD Monographs. It has a safety and efficacy profile of medium certainty. These products are subject to an expedited risk-based review with a target of 30 days.
Class III are NHPs not supported by NHPD Monographs. It has the lowest level of certainty and has the longest review with a timeline of 180 days (+30 days administration for a total of 210 days), which was the review time used previously for all submissions.
In conjunction with the new three-class system, the NHPD has introduced Monograph Attestation Forms to accelerate NHP review and licensing. These novel Attestation Forms are required when any of the ingredients in the product have pre-existing NHPD Monographs. The form confirms that the ingredients listed fully meet all of the conditions stated on the ingredient’s respective NHPD Monographs. This makes the information contained in the Monograph accurate to the ingredient in the product. This expedites the NHPD review process as ingredients that attest to NHPD Monographs do not have to undergo a comprehensive review of its safety and efficacy.
The implication of the new three-class system will be of massive benefit to the industry. The timeline for NPN registration will be greatly decreased relative to the past if the submitted NHP is classified as either Class I or II. The addition of the Monograph Attestation Forms to submissions to the NHPD also speeds up the turn-around time for licensing approval. However, the Monograph Attestation Form places the onus on industry to ensure that the ingredients fully comply with all the requirements stated in the NHPD Monograph if it is being referenced for safety and efficacy.
NHP 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. Contact us at email@example.com or at 1-866-647-3279.