This latest order officially adds 174 substances to the NDSL. For companies manufacturing or importing chemical substances into Canada, this update provides a more streamlined regulatory environment.

Substances listed on the NDSL benefit from:

• Higher Volume Thresholds: Allowing for larger quantities to be handled before specific notification requirements are triggered.
• Streamlined Notifications: Providing a more direct and efficient path to compliance compared to substances not appearing on the list.

It is critical for stakeholders to remain aware of NDSL additions, as these changes can directly impact your notification strategy and timelines. Utilizing substances on this list often results in reduced administrative burden and faster processing for your chemical notifications.

If you need any assistance with these associated regulatory updates, our team is here to assist you.

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Should you identify these two ingredients in your formulations and would like further information on next steps, please contact us.

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For applications received on or after December 15, 2025, priority will be based on the application’s date of receipt, as attestation questions are now integrated directly into the PLA form. This process aligns with the NHP Management of Applications Policy and ensures a fair, transparent, and consistent review process while managing high application volumes. Applicants must ensure that all attestations in the PLA form are accurate, complete, and meet eligibility requirements.

Give us a call to understand more about NNHPD operations.

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The NNHPD is contacting affected licence holders and requesting removal of these carbomers from formulations. Note that any for drug products containing these carbomer ingredients, Health Canada is also reaching out to DIN holders requesting removal of these carbomers from formulations. If you have questions or would like guidance on how this change may affect your products, please reach out to our team.

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The update aims to reduce duplicate reporting and regulatory burden. Under the revised guidance, MAHs are not required to routinely monitor the Canada Vigilance Online database or Health Product InfoWatch for Individual Case Safety Report (ICSR) obligations. However, MAHs must still report serious, unexpected adverse reactions occurring outside Canada, including those identified through foreign regulatory authority databases. If it cannot be confirmed whether the product belongs to the MAH, the report should be submitted to Health Canada with that limitation noted.

The updated guidance took effect on February 19, 2026. If you have questions or would like guidance on how this change may impact your processes, please reach out to our team.

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Here is a simplified breakdown of what has changed and what it means for your product labels:

Sunscreen Monograph Updates:

• Nano Ingredients Recognized: The monographs now explicitly include data on nano titanium dioxide and nano zinc oxide, covering acceptable quantities, dosage forms, and specifications.
• New Filters Added: Bemotrizinol and Bisoctrizole have been added to the Secondary Sunscreen monograph.
• Testing Standards: New in vitro methods for SPF and broad-spectrum testing (e.g., ISO 23675, ISO 23698) are now referenced.
• PA Ratings (UVA Protection): For NHPs and Non-prescription Drugs (NPDs), PA ratings are now permitted as “additional information” on the label. For NPDs, data must be provided to support any additional information regarding the PA rating prior to its use on labels. The PA rating is acceptable as additional information on the label for NHPs containing Zinc Oxide or a combination of Zinc Oxide and Titanium Dioxide. It does not apply to Titanium Dioxide alone (due to lower efficacy against long-wave UVA).

Acne Therapy Monograph Updates:

• More flexibility for marketing claims (expanded terminology): You are no longer restricted to just “acne pimples.” The monograph now allows interchangeable terms such as “zits,” “blemishes,” “spots,” “blackheads,” “whiteheads,” and “comedones.”
• New Performance Claims: Added support for claims regarding mechanism of action, such as “Penetrates pores to eliminate most acne pimples” or “For the management of acne breakouts.”
• Quantity Labeling: You now have the option to express quantity as % w/w or % w/v, depending on your specific formulation.

General Updates for Both Categories:

• Product Facts Table: A standardized Product Facts Table has been added for NHPs in these categories to improve consumer readability.
• Dosage Forms: An updated list of acceptable dosage forms is now included.

The NNHPD has indicated that under this Monograph Update Project, no modifications are anticipated that would necessitate mandatory product license amendments or label revisions. Essentially, these updates are intended to offer more flexibility and modernization rather than forcing a compliance overhaul of existing products. However, if you are launching new products, you should align with these new standards immediately.

Need help navigating these changes? Do you have questions about how these monograph updates affect your specific formulations or labeling strategies? Feel free to reach out to us.

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Key updates:

Separate submissions: Amendment applications must be filed separately from renewal applications. Including an amendment in a renewal will not be accepted. A key reminder that companies are not authorized to conduct any activities related to an amendment until Health Canada has officially approved and amended the Site Licence.

Timelines:

• New applications, Renewals and Amendments: Service standards are 35, 65, or 95 business days, depending on the type of evidence and number of sites.
• Notifications: Processed within 15 business days.
• Health Canada recommends submitting amendment and notification applications at least 65 business days before your SL expires OR after the expiry of the SL for which a renewal has been received.

Amendments: Required for significant changes such as adding or removing new activities, sites, categories, changing addresses, and merging. 

Notifications: Required in case of change to company name, Quality Assurance Person (QAP), site equipment, procedures, or mailing address (where no licensable activities are conducted).

Supporting documents: In addition to the documents listed in the webSLA form, specific supporting documents are required for amendment and notification, as detailed in Bulletin 8.

By following these updated guidelines, you can help ensure faster approval of your site licence amendments and notifications.

Reach out to us if you need help with compiling Site Licence applications.

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This guidance is intended for market authorization holders (for drugs) and licence holders (for NHPs), providing detailed information on how to comply with Canadian regulations, including the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Product Regulations.

The draft guidance clarifies the expected content, format, and submission procedures for two key types of reports:

1. Annual Summary Report (ASR): A comprehensive assessment of all known safety information for a product currently on the market.
2. Issue-Related Summary Report (IRSR): A concise, critical analysis of a specific safety or effectiveness issue, which is prepared upon request from Health Canada.

The primary goal of this update is to enhance clarity and efficiency. Key objectives include consolidating current guidance documents, converting text to plain language, addressing stakeholder questions, and updating submission processes.

A significant change in this draft is the separation of guidance for drugs and NHPs. This change is intended to better address the distinct regulatory and operational considerations for these different product lines.

Health Canada is seeking feedback from stakeholders on the proposed changes. Interested parties are encouraged to review the draft guidance and an associated draft form (“Notifying Health Canada of a significant change in what is known about the risks and benefits of a product”). Feedback can be submitted via email until the December 23, 2025, deadline.

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This is a significant move that aligns NHP oversight with other regulated health product sectors like drugs and medical devices. The DHPID will be a public resource offering detailed inspection information, including dates, compliance ratings, key observations, and regulatory actions. This increased transparency aims to benefit stakeholders and will provide valuable insights into regulatory compliance.

Our team is ready to help ensure your facility’s quality systems are not just compliant, but ‘inspection-ready’ for Health Canada.

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What is GUI-0158?

GUI-0158 is the official guidance document that helps stakeholders understand and comply with the GMP requirements outlined in Part 3 of the Natural Health Products Regulations. It is a key reference for manufacturers, importers, and other parties to ensure the quality and safety of NHPs available to Canadian consumers. The new version replaces the previous guide, with a focus modernizing and clarifying the regulations to better align with current industry practices and international standards.

Key Changes:

The updated GUI-0158 is more than just a re-format; it introduces several new and clarified elements that businesses must be prepared to address.

1. A more user-friendly and comprehensive guide
2. Emphasis on Quality Risk Management
3. Clarified Roles and Responsibilities
4. Enhances focus on Data Integrity
5. Guidance on SOPs, GDP, and records for better clarity
6. Updated Risk Classification section
7. Provides additional guidance on CAPA plan, quality agreements, stability programs, mock recalls, GMP evidence, deviations and out-of-specifications (OOS), batch records and certificates of manufacture, reduced and rotational testing, and testing exemptions.

Preparing for the Transition:

The six-month transition period, from September 4, 2025, to March 4, 2026, is an opportunity for businesses to review and update their processes.

Our team can help you navigate these changes, ensuring your business remains compliant and ready for audits. Contact us today!  

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