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Month: February 2022

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Your Cosmetic Notification MAY get Qualified for processing in 24 hours!

Cosmetic Notifications

What is a cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, of skin, hair or teeth, and includes deodorants or perfumes.”  

This is different than drug and natural health products even though they are all regulated under the Food and Drug Act. The classification of the product depends on its function, purpose, and representation for use (such as claims or recommended purposes).

Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas green tea leaf extract may be licensed as a cosmetic product.

Cosmetic Notification Form

In Canada, it is the Food and Drugs Act and Cosmetics Regulations that require a Cosmetic Notification Form to be submitted by the manufacturer or importer for all cosmetic products. This cosmetic notification form must be completed and submitted at the latest 10 days after the cosmetic notification is first sold. This cosmetic notification form is also used for amendment and discontinuation of sale. This cosmetic notification form must include the following information:

  • name and address of the manufacturer of the cosmetic product
  • name of the cosmetic product
  • function of the cosmetic product (e.g. moisturizer, shampoo, conditioner)
  • ingredient list that includes each ingredient’s name and its concentration percentage or concentration range
  • form of the cosmetic product (i.e. foam, liquid oil, semi-solid lotion)
  • name and address Canadian manufacturer, importer or distributor
  • name and address of individual who manufactures or formulates the cosmetic product
  • name and title of individual who signs the notification form

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Improvements of Cosmetic Notifications Processing

On January 28, 2022, Health Canada notified all cosmetic stakeholders that they are improving the processing of the cosmetic notifications to make it more efficient.  Effective February 5, 2022, Health Canada will use their automated system and process new cosmetic notifications that do not contain restricted or prohibited ingredients.

Once submitted, you will receive a Cosmetic Notification Number issued by Health Canada.  Currently, Health Canada has some unprocessed cosmetic notifications, and these applicable cosmetic notifications will go through the automated system once it is activated on February 5, 2022.  

All other cosmetic notifications that contain restricted or prohibited ingredients will remain be reviewed by Health Canada officers and will not be processed using the automated system.  Keep in mind, this form is used for new products, amendments, and discontinuation of sale.

Resources:

https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

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Natural Health Products Quality Characterization Guide for 2022

Natural Health Product

Natural Health Products have different characterization, identification, quantification, and purity standards that you should know about to ensure the quality of your NHPs. 

Introduction

The purpose of this guidance document is to give stakeholders directions on how to be compliant with Natural Health Products Regulations (NHPR) and meet the quality requirements. Product license holders are responsible and are expected to meet the quality requirements for all types of their Natural Health Products (NHP) that fall under the NHPR. 

Through the NPN application, the product license applicant provides attestation and confirms that the product will be manufactured, packaged, labeled, imported, distributed, and stored in accordance with good manufacturing practices (GMPs). Health Canada has developed several tools in regard to ingredient-specific quality and specification requirements, such as the Natural Health Products Ingredients Database (NHPID), Finished Product Specifications (FPS), and NNHPD pre-cleared monograph. 

License holders may also follow applicable pharmacopeias rather than the tools listed above if it is more appropriate for the ingredient or product.

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Characterization, identification, and quantification standards

The Natural and Non-Prescription Health Products Directorate (NNHPD) requires the characterization of medicinal ingredients to evaluate evidence of its identity, which relates to the safety and efficacy of the Natural Health Product. The characterization could be the ingredient’s distinguishing features or special qualities. Examples are chemicals (e.g. isolates, synthetic duplicates), processed ingredients, and extracts (e.g. fortified extracts, standardized extracts). Depending on the type of ingredient, identity testing may also be required and may be performed at the raw material or finished product stage. This is to determine the correct ingredient or plant species/plant parts from adulterants. 

The finished Natural Health Product specifications should list the quantity per dosage unit of all medicinal ingredients. Tolerance limits should be 80-120% of label amount or conform to the applicable pharmacopeial standards. It could be either Quantification by assay (tested at finished product stage) or Quantification by input, depending on the characterization of medicinal ingredients. 

Purity standards

The NHPR requires the finished product specifications to list out the information related to the purity of the Health Canada Natural Health Products. This means to include test methods and tolerance limits for Microbial Contaminants and Chemical Contaminants. If this is tested at the raw material stage, it is not required to repeat the test again at the finished product stage as long as GMPs are in place to prevent additional contaminants. 

Microbial contaminants testing includes Total viable aerobic plate count, Contaminating fungi (yeast and mold), Salmonella SPP, Escherichia coli, Staphylococcus aureus, and Pseudomonas aeruginosa. Chemical contaminants are elemental impurities such as heavy metals. This can be tested individually, or as total heavy metals with acceptable test methods in NHPID, Pharmacopeial, or internationally accepted 

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methods. Topical products have different requirements for heavy metal limits. Depending on the ingredients in the Natural Health Product, other contaminants testing include aflatoxin, cyanobacterial toxins, animal hormones, pesticide residues, solvent residues, antibiotic residues, radioactivity, oxidative stability, and marine oil contaminants.

Additional tests and criteria

Product license holders must ensure all non-medicinal ingredients are within restrictions in NHPID and are used in quantities to support the purpose of its use. Other performance tests may be required depending on the nature of the product, including Disintegration, Dissolution, Uniformity of dosage units, Antimicrobial effectiveness testing, and Stability testing.

Resources:

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html#three2

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Top 10 Fruitful Medical Device Development Principles

Medical Devices Development

Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), have come together to identify 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). The goal of GMLP is to help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).

The 10 guiding principles compiled by the regulatory agencies will hopefully lay the foundation for developing Good Machine Learning Practice that address the unique nature of medical devices using artificial intelligence and machine learning. They will also help cultivate future growth in this rapidly progressing field.

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The 10 guiding principles may also be used to

  • Adopt good practices that have been proven in other sectors
  • Tailor practices from other sectors so they are applicable to medical technology and the health care sector
  • Create new practices specific for medical technology and the health care sector

The 10 guiding principles are summarized below: 

1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle: It’s important to have a thorough understanding of a device’s intended integration into clinical workflow (e.g. desired benefits, associated patient risks) to help ensure that the medical device is safe and effective and addresses clinically meaningful needs.

2. Good Software Engineering and Security Practices Are Implemented: Model design is implemented with attention to the “fundamentals”: good software engineering practices, data quality assurance, data management, and robust cybersecurity practices. 

 3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population: Data collection protocols should ensure that the relevant characteristics of the intended patient population (e.g. age, gender, sex, race, and ethnicity), use, and measurement inputs are sufficiently represented in a sample of adequate size in the clinical study and training and test datasets, so that results can be reasonably generalized to the population of interest. 

4. Training Data Sets Are Independent of Test Sets: Training and test datasets are selected and maintained to be appropriately independent of one another.

5. Selected Reference Datasets Are Based Upon Best Available Methods: Accepted, best available methods for developing a reference dataset (that is, a reference standard) ensure that clinically relevant and well characterized data are collected and the limitations of the reference are understood. 

6. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device: Model design is suited to the available data and supports the active mitigation of known risks, like overfitting, performance degradation, and security risks. The clinical benefits and risks related to the product are well understood, used to derive clinically meaningful performance goals for testing, and support that the product can safely and effectively achieve its intended use. 

7. Focus Is Placed on the Performance of the Human-AI Team: Where the model has a “human in the loop,” human factors considerations and the human interpretability of the model outputs are addressed with emphasis on the performance of the Human-AI team, rather than just the performance of the model in isolation.

8. Testing Demonstrates Device Performance During Clinically Relevant Conditions: Statistically sound test plans are developed and executed to generate clinically relevant device performance information independently of the training data set. 

9. Users Are Provided Clear, Essential Information: Users are provided ready access to clear, contextually relevant information that is appropriate for the intended audience (such as health care providers or patients) including: the product’s intended use and indications for use, performance of the model for appropriate subgroups, characteristics of the data used to train and test the model, acceptable inputs, known limitations, user interface interpretation, and clinical workflow integration of the model. 

10. Deployed Models Are Monitored for Performance and Re-training Risks Are Managed: Deployed models have the capability to be monitored in “real world” use with a focus on maintained or improved safety and performance. Additionally, when models are periodically or continually trained after deployment, there are appropriate controls in place to manage risks of overfitting, unintended bias, or degradation of the model (for example, dataset drift) that may impact the safety and performance of the model as it is used by the Human-AI team.

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Resources:

https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html#three2
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Your Health Canada eMCE Update For 2022

Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification that their medical devices can be marketed in Canada and meet Canadian regulations. As a service to the Canadian medical industry, Health Canada through the Regulatory Operations and Enforcement Branch (ROEB) issues these certificates to facilitate the export process. The Manufacturer’s Certificate to Export licensed medical devices from Canada (MCE) includes an attestation by both the manufacturer and by Health Canada. To obtain an MCE, the following requirements must be met:

  • the medical device is manufactured in Canada
  • the medical device has an active Canadian device license for Class II, III, and IV devices, or
  • the manufacturer of a Class I device has an active MDEL

Previously, the application process for MCE has been manual / paper-based with the applicant sending a completed and notarized application form as well as supporting documentation submitted to the Medical Devices Compliance and Licensing Unit of the Regulatory Operations and Enforcement Branch of Health by regular mail. Unfortunately, due to the impact of Covid-19 pandemic, Health Canada stopped processing requests for paper-based MCE.

Here comes the good news, Health Canada on January 5, 2022, announced the launch of the pilot program for electronic MCE (eMCE). This process will replace the suspended paper-based process that requires wet-ink signature from the company official. The new eMCE with e-signature is a more efficient process that offers a more environmentally friendly way of doing business. Aside from this benefit, eMCE will no longer require additional documentation, such as a cover letter, notarized form, and a copy of all listed licences. In addition, the new eMCE application form will produce a certificate entitled “MCE/Certificate of Free Sale”

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Steps to completing the new eMCE application form

  1. For each licensed or authorized medical device that you intend to export, complete the licensing or authorization information for each medical device. 
  2. For medical device(s) with a medical device establishment licence (Class I), provide the licence number, company ID and device name. 
  3. For medical device(s) with a medical device licence (Class II-IV), provide the licence, device ID, Class of the device and the device name. 
  4. For medical device(s) with an interim order authorization, provide the authorization ID, authorization date, device name, device ID and the manufacturer’s name. 
  5. Provide the name and address for the manufacturer of the device(s). This should be the name of the MDEL, MDL or IO authorization holder. 
  6. Submit a completed and electronically signed eMCE application with supporting documentation* to the Medical Devices Compliance and Licensing Unit of the Regulatory Operations and Enforcement Branch of Health Canada.

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*Supporting Documentation

  • Class II, III or IV devices — a copy of the Medical Device Licence (MDL) for each device. 
  • Class I devices — a copy of the Medical Device Establishment Licence (MDEL). 
  • Class I, II, III or IV devices authorized under the IO — a copy of the IO authorization for each device as applicable.

Features of the eMCE 

The eMCE will be digitally signed with an electronic signature that authenticates the signer’s identity and demonstrates proof of signing. The certificate will also be locked to protect the integrity of the certificate and prevent any modifications to the document from being made after it is signed and prevent the content in the certificate from being copied. The electronically signed certificates will be sent by email only to the applicant’s email address, which was used to submit the application.

The eMCE pilot project will last for 6 months from January 5, 2022.

Resources:

Health Canada Launches Electronic Manufacturer’s Certificate to Export.

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/electronic-manufacturer-certificate-export-medical-devices.html

Guidance to apply for a Manufacturer’s Certificate to Export licenced medical devices from Canada (GUI-0097)

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/application-manufacturer-certificate-cover-export-medical-devices-0097/document.html#a4

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FDA Qualified Health Claim for Magnesium 2022


The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or object to some qualified health claims regarding magnesium and the reduced risk of high blood pressure (hypertension), so long that the claims are worded properly to avoid misleading the consumer. The claims are essentially accompanied by a disclaimer to convey the available scientific evidence that supports the claim. 

The Center for Magnesium Education and Research LLC. has sent a petition to the FDA to allow a health claim regarding the consumption of magnesium and a reduced risk of high blood pressure. Thus, confirming and characterizing a relationship between the ingredient and a disease or health condition. In this case magnesium and blood pressure.  

Upon review of the submitted evidence, FDA has decided that there is a valid support for such a claim to be made for conventional foods and dietary supplements. FDA has released a guide for how they will enforce this new claim. 

The following health claims for conventional foods and dietary supplements are included in the FDA’s letter:

  • “Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
  • “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, the FDA has concluded that the evidence is inconsistent and inconclusive.”
  • “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”

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It is strongly encouraged that your conventional food and/or dietary supplement labels capture the full statements issued by the FDA. We recommend using the statement verbatim to avoid misleading the consumer.  

The amount of magnesium required to justify such a claim is 84 mg. Please ensure your conventional food or dietary supplement product does not also contain high levels of total fat, saturated fat, cholesterol, or sodium as these ingredients may disqualify your claim. 

The full petition and FDA response reports are available online and in the resource links below. Please reach out if you have any questions about blood pressure or magnesium claims.

Resources:

https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-qualified-health-claim-magnesium-and-reduced-risk-high-blood-pressure

https://www.fda.gov/media/155304/download

https://www.fda.gov/food/food-labeling-nutrition/qualified-health-claims

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