Distributed manufacturing is a decentralized manufacturing approach in which equivalent manufacturing units operate at different locations under the oversight of a single quality system. Under the proposed “hub-and-spoke” model, a central hub provides quality oversight, while multiple equivalent manufacturing units or “spokes” manufacture the same drug at different locations.

Currently, each manufacturing unit located at a different physical location generally requires a separate establishment registration. The proposal would allow qualifying distributed manufacturing networks to register as a single establishment, with a streamlined process for adding, relocating, or removing manufacturing units. Advance notification to FDA would be required for relocation or closure of a unit.

The proposal would also clarify that certain foreign establishments manufacturing drugs or APIs that ultimately enter the US market through another foreign establishment must register with FDA and submit applicable drug listing information. This is intended to improve FDA visibility into upstream drug supply chains.

If finalized, the changes could reduce duplicative registration requirements for qualifying distributed manufacturers while increasing supply-chain visibility and registration obligations for certain foreign establishments. The proposal is not currently effective. Follow us for more such updates.

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Key Procedural Updates:

The bulletin outlines several critical changes to the submission and screening process for regulated entities:

• Combined Screening Timelines: Health Canada is streamlining its notification process. For applications involving foreign buildings that utilize full Good Manufacturing Practice (GMP) evidence, including requests for extending a New Evidence Required By (NERBY) date, applicants will now receive a single, combined screening completion notice within 95 days. This consolidates the previously separate DEL screening completion notice and the GMP screening acceptance notice, and Health Canada will no longer issue a standalone DEL screening completion notice at the 65-day mark.

• Modified Milestone Targets: For applications assigned to Stream 3 (foreign building applications requiring full GMP evidence review), Health Canada will now issue either a GMP compliance notification or a GMP compliance notification of a NERBY extension grant within 170 days, adjusting the previous target of 140 days.

• GMP Evidence Submission Methods: While Health Canada continues to recommend that importers submit GMP evidence concurrently with their DEL application, they are introducing greater flexibility. GMP evidence can now be submitted directly from the foreign building or by a third party acting on its behalf.

• LiquidFiles Implementation: To facilitate the secure transfer of large data packages, the bulletin introduces the use of LiquidFiles for submitting GMP evidence. For files exceeding 1 GB, applicants must submit them in batches using this system. 

While these changes alter submission mechanisms and specific milestone notifications, Health Canada has explicitly stated that the overall DEL application service standards established in guidance document GUI-0127 remain unchanged.

Companies importing or manufacturing within Canada should review these updated timelines and coordinate with their foreign sites and third-party auditors to ensure GMP evidence submissions align with the new LiquidFiles procedures and combined screening targets.

Our team is here to assist you with DEL applications, reach out today.

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The FY 2027 MDF and CMO facility fees represent an increase of approximately 149% from FY 2026. FDA attributes the increase largely to a one-time downward operating reserve adjustment that reduced FY 2026 facility fees.

A key change under OMUFA II is the consolidation of the previously separate facility and OMOR fee announcements into a single annual Federal Register notice beginning with FY 2027. This is intended to provide a more predictable and streamlined fee-setting process for FDA and industry.

The FY 2027 facility fee will be paid in two equal installments: 50% on October 1, 2026 and the remaining 50% on February 1, 2027, subject to the statutory appropriations conditions. From FY 2028 onward, the full facility fee will generally be due October 1. OMOR fees remain payable upon submission of the OMOR.

Companies that own qualifying OTC monograph drug facilities, including eligible CMOs, should assess their FY 2027 fee obligations and budget for the substantially higher facility fees. Companies planning to submit OMORs should also account for the increased OMOR fees. FDA’s OMUFA requirements apply independently of other FDA user fee programs such as PDUFA, GDUFA or MDUFA.

For more such updates, contact us.

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The recent revisions intend to broaden the list’s applicability, increase labelling flexibility, and reduce the overall administrative burden for companies.

​Key Changes in the August 2026 Update:

• ​Transition to a Non-Exhaustive List: For NHPs and NPDs covered by List D (low-risk products used on the skin or in the mouth), the terms provided in Health Canada’s table are now treated as examples rather than a strict, exhaustive list. Companies may use other equivalent wording provided it conveys the exact same meaning and meets Health Canada’s requirements.

• ​Flexibility in Product Claims: The revised guidelines now allow the application of interchangeable terminology directly to NHP claims and the uses or indications for List D NPDs.

• ​Grammatical Adaptability: Companies have additional flexibility with grammar, such as using different verb tenses interchangeably (e.g., “ask” versus “asking”). This is permitted as long as the fundamental meaning of the sentence is not altered.

​Important Limitations to Keep in Mind:

• ​While the updated guidance provides more freedom to create consumer-friendly labels, it is not a blanket authorization to rewrite product information.
• ​Interchangeable terms must always convey the identical meaning of the authorized term and cannot be false or misleading.
• ​Some term substitutions are unidirectional. For example, the term “avoid” can be substituted with the stricter “do not,” but “do not” cannot be weakened to “avoid”.

​This regulatory update presents a valuable opportunity for NHP and NPD companies to review their existing/upcoming labels and replace overly technical jargon with more accessible language for consumers.

​If you need assistance with reviewing your label claims, please reach out to us.

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Key updates include:

Reporting Requirements: Following confirmatory testing, Market Authorization Holders (MAHs) must assess whether nitrosamine impurities exceed the established Acceptable Intake (AI) limit and determine whether market action is required. MAHs are no longer required to notify Health Canada each time an elevated nitrosamine impurity level is detected. Notification is only required when a recall decision has been made, in accordance with the Drug, Natural Health Product and Biocide Recall guide (GUI-0039).

Risk Mitigation Expectations: While the guidance maintains a 3-year CAPA implementation timeline, Health Canada expects MAHs to implement risk mitigation measures and reduce nitrosamine levels below AI limits as soon as possible.

Safety: New contact information has been added for enquiries regarding applicable Acceptable Intake (AI) limits, including proposal for new AI limits.

Appendix 2: The decision tree has been updated to reflect the revised expectations for filing nitrosamine risk mitigation-related changes. 

If you wish to understand how these changes might affect your business, please reach out to us.

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If you have questions or would like guidance on how this change may impact your registrations, please reach out to our team.

The post FDA Issues Final rule on Nation Drug Code (NDC) format appeared first on Focal Point.

The Numbers at a Glance

For FY 2026, the FDA has adjusted fees upward, reflecting an approximate 4.9% increase compared to the previous fiscal year.

Tier 1:

FY2026 – $587,529

(FY2025 was $559,777)

Tier 2:

FY2026 – $117,505 (FY2025 was $111,955)

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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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This proposal highlights the effectiveness of the OTC Monograph Order Request (OMOR) pathway. Initiated by a request from DSM Nutritional Products LLC, the FDA is proposing the inclusions of bemotrizinol at concentrations up to 6% without requiring a full New Drug Application. The FDA’s review confirmed that the ingredient meets high safety standards, offering broad spectrum (UVA/UVB) protection with low skin absorption and a favorable tolerability profile.

The FDA is currently inviting public feedback on this proposal via the OTC Monograph@FDA portal. If the agency ultimately concludes that bemotrizinol is generally recognized as safe and effective (GRASE), it will issue a final order formally adding the ingredient to he OTC Monograph M020.

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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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