COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of applications with respect to the established service standards outlined in the Natural Health Products Management of Applications Policy. Similar delays were observed for NHP site license submissions. After the worst of the COVID-19 pandemic had passed, the NNHPD ramped up the review process to clear the backlog of non-priority product, site, and post-license submissions. As a result, regular updates are being provided by the NNHPD via the Performance standards for NHP applications Stakeholder Meetings, with the most recent one being March 23, 2022.
For non-COVID submissions (April 2021 to February 2022) 9,297 NHPs were licensed which includes 53% Class I; 13% Class II; 34% Class III applications. 718 sites were licensed/renewed. As per the recent performance standards for Class I applications, 93.4 % of new applications and amendments were processed within the service standard (60 calendar days) while for class II (service standard – 90 calendar days) and class III applications (service standard – 210 calendar days), these numbers were 87.8% and 59.6% respectively.
Post-licensing submissions are subdivided into two categories: amendments and notifications. Amendments are defined changes to an NHP that may have an impact on the safety, efficacy, and/or quality of the product. On the other hand, notifications are defined as changes to an NHP that do not significantly impact the product’s safety, efficacy, and/or quality. Product license amendments follow the service standards as applicable for the relevant class of application while notifications have no established service standards. As per the recent data released on performance standards, 98% and 71% of notifications received in 2021 and 2022 respectively were processed.
Within the past year, the NNHPD has managed to achieve 50% year-to-date performance for new applications and amendments for non-COVID stream I Site Licence Applications while for stream II the numbers were 81% year-to-date performance for new applications and amendments. 318 site licence renewals were completed this fiscal year
System updates for Product Licence Applications
The web-based Product Licence Application (web PLA) form is an integral component of any natural health product license submission package. The basis of developing this web-based platform is to allow web PLA form searches and ease of populating data from the Natural Health Products Ingredients Database (NHPID). Earlier version 3 and version 4 were available. Web PLA version 4 allowed in-form compendial (NNHPD monograph) (class I) validation as opposed to web PLA version 3.
Several system improvements have been implemented to support priorities for Product Licence Applications. New web PLA version 4 was released on April 9, 2022.
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With the release of this latest version of web-based PLA, it was announced that web version 3 will be discontinued for new product license applications. Access to NNHPD web PLA previously finalized using version 3 will still be available for responding to IRNs. Also, these version 3 applications will be available for viewing using any browser and responding to IRNs until the end of November 2022.
It was also announced that moving forward, web PLA version 4 will support the selection and population of both validated and non-validated monographs. The validation supported monograph table was removed from the system. Following changes/updates were proposed for the new NNHPD web PLA version 4.
- As per the Natural Health Products Management of Applications Policy, class I applications are required to comply with all the parameters of an individual monograph. The number of NNHPD monographs that can be referenced is subject to the maximum of one for class I applications while this number can be two or more NNHPD monographs for class II applications. Earlier web PLA version 3 was recommended for all classes of applications based on non-validation supported NNHPD monographs, but the recent version can be used for all monographs including the ones that are not validation-supported. These monographs will be included in the picklist and marked as “(validation unavailable)”. Such applications will be finalized without validation with the status being displayed as “Not validated”.
- Aside from the above changes, several other changes have been made to the web PLA to make it more user-friendly and sensical. For example – the option to choose a dual-route of administration to support aromatherapy submissions, excluding pregnant and breastfeeding risk statements for products intended for male sub-population only, etc.
System updates for Web Site Licence Application (web SLA)
Version 3.0 of the web SLA was released in April 2022. Several updates have been made to make this new version more intuitive and detailed. Some of these changes include the addition of options to include qualification of the Quality Assurance Person, new validation features, the addition of an NPN lookup in the Product Information module, etc.
The ever-present changes with these updates in system and performance standards make it increasingly challenging to keep up with the most up-to-date regulatory information. Planning is a critical component of any product launch or site licensing activities; hence it is crucial to be keep abreast with the impacts of these changes to the plans for your products, sites, and their operational activities.
