Cyctek feedback on the draft guide on Natural Health Products’ Annual Summary Report

December 2025

Introduction

Cyctek Inc. welcomes the consultation on the draft guidance on preparing and submitting summary reports for marketed drugs and natural health products.Cyctek has beenan NHPGMP-compliant site license holder since the implementation of the Natural Health Product Regulation (NHPR). Our interest is in the NHP side of the updated guide, which is important at this juncture in light of the publication of the report on red tape reduction. Cyctek Inc. would like to contribute ideas that comply with the NHPR and support a more efficient and user-friendly Summary report process for the NHP industry.

Background

The NHP Regulation is built upon the 1998 Parliamentary Heal Committee Report, which concluded “balance must be struck between safety and access”.   The NHPR in section 24 (2) specifically requires Annual Summary reports for products that are being marketed. On September 8, 2025, Health Canada and the Public Health Agency of Canada published their report on red tape reduction. At a high level, the report outlines the actions they are committed to taking. Point 2: “Introducing flexible risk-based vigilance requirements for all NHPs and NPDs”. Coupled with the news of the delay in the implementation of fees for natural health products on November 18, all of them form the background of the Summary report recommendations from Cyctek Inc.

Feedbacks

The feedback from Cyctek Inc. is limited to NHPs only. We aim to provide reasonable and practical feedback that meets regulatory requirements, yet can be implemented in the near term to reduce resources for regulatory compliance for all stakeholders. If you find any of the feedback not pragmatic, we would love to hear back from you.

The guidance on preparing Summary reports on lines 90 to 92 specified ”ASRs are not expected to discuss problems related to quality or good manufacturing practices, unless they result in adverse clinical outcomes. Good manufacturing practices (GMP)-related safety issues should be distinguished from ingredient-related safety issues.”, which excludes Good Manufacturing Practices (GMP) issues unless they cause adverse reactions in products. Adhering to the prerequisites in lines 90-02, the following feedback supports our recommendations for the proposed summary report guide.

1. NHP ingredients have more than 25 years of clinical practice experience; they cannot be compared to a drug’s newly discovered active ingredients that have limited safety information and clinical experience. Lines 311 to 313 of the proposed guide did not acknowledge that almost all manufacturers and regulatory authorities have excellent knowledge of NHP ingredients because changes in NHP are exceptions, not the norm. Thousands of multivitamin/mineral and omega-3 products contain ingredients that are well-known and very safe. Traditional products, such as TCM, Ayurvedic, and indigenous medicines, have remained largely unchanged, in some cases for centuries. NHPs Summary reporting should not have a close resemblance to new active substances in drug discoveries.  
2. Lines 341 and 342 also describe situations that are not the norm for NHPs. In fact, for most licensed NHPs, no adverse reaction is the norm. Historically, NHPs have minimal adverse reactions when GMP issues are excluded. This is supported by the Health Canada Health Product InfoWatch September 2021[1] publication.  Page 5, Table 1 of the InfoWatch report showed that Natural Health Products accounted for 0.6% of the adverse reactions in 2020. Drugs have over 124 times more adverse reaction cases than NHPs. We understand that NHPs are not risk-free, but NHPs should have much lower Annual Summary Report requirements than Drugs. If Health Canada finds that the combined use of both NHPs and drugs puts patients at a higher risk than using NHPs alone, the risks should be managed differently from the ASR requirements. 
3. The majority of the NHPs are Class I and II products derived from NNHPD monographs; lines 355 to 357 do not entirely reflect this fact. Medicinal ingredients for NHPS are well established, and rarely is a new synthesized active substance that has a limited safety history. There is certainly an opportunity to make the NHP Summary report simpler further. The reduced risk level should be mentioned (according to the risk-based approach) in the guide to support the NHP Summary report requirements.
4. Adding “Existing change processes (ingredient issue form, and ad hoc summary reports) should be used” for the situation described in lines 413 to 414 would avoid unnecessary contacts with regulatory staff.
5. With the lower risk of the NHPs, we can simplify the Summary report process to ad hoc reporting on adverse reactions for any discontinued NHPs (lines 445). This could support “the red tape reduction” initiative. If this suggestion is found to violate NHPR section 24, then we can consider it in the future.
6. We would like the guide to provide additional details on line 461. I believe the industry needs to know who can impose “a term or condition”. Under what circumstances does Health Canada put a term or condition on an NHP? How many of the cases have occurred in NHPs? An example will be helpful. Based on risk, can we reduce those terms and conditions due to the lower risk level?
7. Line 467, the word ”drug” should be “NHP”.
8. It will be beneficial to specify in the guide the Annual Summary Report process in the request, submission and review section. The ability to track submissions, acknowledge receipt, request updates, etc., could be helpful in automating the exchange of information during the Annual Summary reporting process. A system like the one used by the onsite GMP audit team (Enforcement branch) or the one used by the trademark office could facilitate this.

Recommendations

1. To support the feedback points i) and II) above, we suggest adopting a Summary report template and mentioning its use in the guidance document. Due to the infrequent changes of ingredient risks in a monograph, the template can be used as a default report for stakeholders to prepare the annual Summary report of a product. Each monograph may create its own template. A product that attests to multiple monographs may choose any one of the monograph templates.  Using templates could also save time for the Health Canada team in reviewing the Summary reports. We find that the Summary report template can be adapted from the current process. For example, the Marketed Health Products Directorate, on occasion, publishes Summary Safety Reviews for a monograph. A recent one is no. 25-104738-836, published on September 8, 2025, about “Turmeric and Curcuminoids for Oral Use”; there is also one no. 25-103829-296 for Garcinia on September 17. We believe adopting existing reports from Health Canada or the industry is an effective approach that makes the Summary reporting process more efficient. Specific simplifications of the NHP Summary report should be included in the guide to illustrate how it differs from drug Summary reporting. The safer record of NHPS deserves a more efficient process in the Annual Summary Report guide. The current drug-similar wording in the proposed guide needs revision.
2. A more elaborate Summary Report template (one that is similar to MHPD Summary Safety Reviews) may be adopted for any NHP that does not attest to a monograph.
3. Engage the participation of stakeholders/industry to develop and update the Summary Report templates for monographs. The template can be used for an adverse reaction report or annual reporting. Cyctek Inc. will be happy to contribute to the Summary Report template for the TCM monograph.
4. Further involvement of the industry in producing an Annual Summary Report for a monograph that experienced no change at all within the year. The Summary reports can then be reviewed by Health Canada and published to stakeholders via the existing process. Product license holders can use the reviewed reports from Health Canada and add their product information to complete their annual reporting requirements.
5. Based on the findings in the September 2021 InfoWatch publication, I recommend planning the update of section 24 (2) NHPR on the Annual Summary reporting requirement in the next revision of the NHPR. This is important to reflect the difference from drugs, reflecting the much lower adverse reaction findings of the Canadian experience.

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[1] https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medeffect-canada/health-product-infowatch/september-2021/HealthInfoWatch-September-2021-ENGLISH.pdf