May 2021 - Quality Smart Solutions

Performance Standards for NHP Applications

The coronavirus-19 (COVID-19) pandemic has had a long-lasting effect on many of the processes done in business and everyday life. One of the resulting main effects is delays in application processing times. From simple applications such as passports to larger-scale applications such as NHP licensing.

Prior to the pandemic, Natural and Non-Prescription Health Products Directorate (NNHPD) had a well-established service standard for Class I, II and III applications, which is outlined in the Management of Application Policy (MAP) guidance as shown below:

As the focus had started to shift to prioritize COVID-related product applications, a resultant de-prioritization of the non-COVID-related applications occurred. Not surprisingly, the volume of priority applications began to create a backlog on the non-priority product, site, and post-license submissions, thereby increasing the service standards. Within the past year, NNHPD has managed to achieve the following:

NNHPD licensed 4,290 new alcohol-based hand sanitizers and issued 2,054 interim Covid site licenses.
NNHPD issued 10,826 Non-COVID related product licence and 1,126 site licence decisions

To manage stakeholder expectations, NNHPD provided discretionary dates in which they hoped to see 90% of applications fulfill their original committed service standard. These dates were further broken down into application type and class. In addition, regular updates were provided by NNHPD via the Performance standards for NHP applications Stakeholder Meetings, with the most recent one being March 24, 2021.

As of this fiscal year, NNHPD has already completed 5,046 Class I submissions, which is up 343 submissions from the previous year. The standard processing time for Class I submissions is 60 calendar days from the date of submission. NNHPD was able to meet the 90% target in months of January (93.8%), February (97.4 %), and March (91.4%).

For Class II, 2,221 submissions were completed in this fiscal year, which is up 301 submissions from the previous year. The standard processing time for Class II submissions is 90 calendar days from the date of submission. NNHPD was able to meet the 90% target in January (93.7%), February (93 %); however, they fell slightly below in March (89%).

Lastly, 3,298 Class III submissions were completed within the current fiscal year, which is up by 585 submissions from the previous year. Therefore, as a result, NNHPD is on track to meeting their 80% goal for the original 210 calendar day service standard, with over 88% of the backlog completed.

While much has been achieved, NNHPD has warned about the impacts of further volume increases will have on the current system. For example, a 40% increase in Class II and Class III applications was observed in March; thus, NNHPD has asked to limit submissions to critical applications.

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. In contrast, notifications are defined as changes to an NHP that do not significantly impact the product’s safety, efficacy, and/or quality. Similar to new product submissions, amendments follow the 3 Class application system and service standard. On the other hand, notifications have no established service standard and do not follow the 3-class system.

Only 63.9% of the received amendments have been issued a decision. There are approximately 147 submissions received in 2020, which remain to be processed. Similarly, 62% of received notifications have been completed to date.

The target has been successfully met for both Stream I (94%) and Stream II (96%) site license applications. Approximately 201 Stream I submissions, 389 Stream II submissions, and 318 renewals have been completed this year. In addition, extensions were granted for renewals to accommodate further processing.

Although it may seem that little can be done as a stakeholder to speed up the licensing process, there is one way, using the most up-to-date licensing forms. Within the last year, NNHPD has launched online webforms to be used in application submission. The web-based Product Licence Application (web PLA) and the amendment and notification form (ANF). The forms have a validation component built-in, which thereby lessens the burden for NNPHD. A lower burden allows for greater processing times and avoids unwarranted application refusals.

The ever-present changes resulting from COVID make it increasingly challenging to keep up with the most up-to regulatory information. As planning is a large part of the product launch, it is crucial to be in the know on impacts to your product plan. Our Experts at Quality Smart Solutions can offer support to your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Coming into Force: Human Milk Fortifiers Regulations

After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for these types of products, Health Canada has released new Directives/Guidance Documents and Publications in Canada Gazette part II. These articles pave the way for new regulatory requirements and now list Human Milk Fortifiers (HMFs) within the Food and Drugs Regulations.

This framework will enhance the ability of industry to add vitamins, minerals, and amino acids to human milk, in turn, providing infants with these important nutrients. These types of products are commonly administered to premature and low birthweight infants, bolstering the benefits of human milk to aid in growth and development.

A clear pathway to market will increase efficiency and accessibility for these products in medical and prescribed home care settings, thus benefiting medical practice and the individual infants. There are currently 10 approved HMFs. Many more are expected to be approved with the implementation of this programme.

Safety of infants is of utmost priority. This framework lays out clear guidance for the regulation and oversight of safe and innovative products. A risk-based approach will be taken to implement and enforce these products.

Quick Definitions:

Human milk fortifier means a food that: (a) includes at least one added vitamin, mineral nutrient or amino acid, and (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state.

Infant means an individual who is under the age of one year.

New (Draft) Guidance Documents:

Health Canada is currently drafting 8 new guidance documents regarding HMFs. If you would like access to any specific draft guidance document such as: Guide on the Sale of Human Milk Fortifiers please reach out to our team.

Premarket Submission:

HMFs were previously marketed under the Temporary Market Authorization Framework, like caffeinated energy drinks and supplemented foods. Now, HMFs are required to be submitted to the regulator and reviewed prior to sale on their own. Applications are to be submitted to allow sufficient time for review prior to April 30, 2022. Applications shall include the following components:

Brand name
Manufacturer’s name and address
Name and address of other manufacturing establishments
Quantitative list of ingredients
Formulation rationale
Product specifications, Including nutrients, microbiological and physical quality
QC details for product and ingredient testing
Details of manufacturing process and QC procedures
Stability results, to determine expiry
Nutritional adequacy support, when consumed under the proposed directions
Description of packaging
Directions for use
Copy of all labels to be used
Name and time of applicant who signed and dated the application

Authorization and Application Review:

Should the application be deemed complete and sufficient the product would be authorized. The regulator may also request changes or conditions prior to approval. Additional information or confirmations may be requested during the submission process. Resubmissions and new approval would be required if your formula undergoes a major change, unless otherwise authorized by the regulator. If any information submitted is missing, considered false, misleading, or deceptive the application may be refused.

Legal Sale:

HMFs will only be sold to hospitals directly or to individuals for home use with a written order (prescription) from an authorized physician, nurse practitioner, or dietitian (Health Care Practitioner). Industry will not be able to sell these products direct to consumer.

Label Requirements:

Labels of HMFs are required to carry the following information on the outer label:

List by quantity the amount of protein, fat, carbs, and fibre (in grams)
Statement of energy value/calories
Statement of quantity (in mg or mcg) of all vitamins, minerals, or amino acids
Statement of quantity (in mg or mcg) of any other nutritive substance
Storage instructions for both opened and unopened containers
Directions of use including preparation and storage instructions
Statement to only use this product under medical supervision
Expiration date
Lot number
Any other statements or content required to be added during review.

Information can be displayed on outer label, inner label, or on an affixed leaflet.

You are not permitted to list the following on any labelling or any advertising materials to percent daily value amounts.

Health Claims:

It is suggested to remove/limit all health claims regarding these products, as it would be the health care practitioner’s discretion when and why they are dispensing the product. Marketing verbiage and imagery should also be minimal.

Formulation:

Ingredients used in HMFs may include Amino acids, Minerals and Vitamins.

Item 6 of tablet in section D.03.002

Also, based on recent safety assessments, several new food additives will be permitted for use in Human Milk Fortifiers. These include carrageenan, gellan gum, lecithin, monoglycerides, potassium citrate, potassium hydroxide and sodium citrate. Please keep in mind each of these may have specifically approved purposes and required cautionary statements. Otherwise, Infant foods are currently prohibited from containing food additives, but some can be granted. There currently are no limits set for these ingredients for HMFs the responsibility will be on the applicant to prove each ingredient is safe and effective.

Safe Foods for Canadians Regulations Note:

All foods in Canada will be regulated by the Safe Foods for Canadians Regulations. Conventional and supplemented foods now have additional requirements such as: Licensing, Traceability and Preventative Controls. Reach out to our team for assistance complying and importing within this new framework.

References:

Canada Gazette Part II Listing

List of Human Milk Fortifiers

List of Guidance Documents

Food and Drug Regulations