Consultation feedback: Draft Good Manufacturing Practices guide for Natural Health Products

December 2024 feedback to NNHPD on the draft NHP GMP practice guide

Introduction

Cyctek Inc. welcomes the development and publication of the good manufacturing practices guide for natural health products. Cyctek has beenaGMP-compliant site license holder since the beginning of the establishment of the Natural Health Product Regulation. This updated guide is vital for guiding the NHP industry and GMP license assessment office. The guide will facilitate clarity and efficiencies for NHP GMP assessment, operations and licensing.

Specification section

I would like to share my experiences in NHP GMP operational practice, training, and site license consulting in this document, to make the operational and licensing aspects of NHP GMP more transparent and effective.

I welcome some of the details in the proposed guide. Under the Quality Risk Management section, the point “evaluation of the risk to quality is based on scientific knowledge and experience with the process is linked to the protection of the consumer”. The keyword “experience” is the most important part of herbal and traditional medicine. The word “experience” is also mentioned in the Quality of Natural Health Products Guide.However. there is a lack of representation in this section on all origins of traditional medicines. We do not see “experience” mentioned in the specification section and “experience” does not seem readily accepted in current site license renewal. On multiple occasions, I have seen IRN questions like “Justification for quantifying majority (if not all) of the medicinal ingredients by input, as opposed to testing these ingredients for quantity in the finished product. Ensure that the rationales provided are scientifically based.” The IRN question mentioned “scientifically” but did not mention “experience” or “traditionally”.  The updated guide did provide the condition that supports medicinal ingredient by input “i.e. the medicinal ingredient is a whole plant (or part of a plant)”. It would be direct and clearer to mention “experience” and “Traditional” in subsections quantification by input and rotational testing. The clarity could help license applicants and assessment officers that in traditional medicines, input was the only way until modern-day testing technology is adopted. The NHPR and NHP GMP have led to the development of a world-leading safe and vibrant natural and traditional medicine industry, we should not only focus on generality but also on specific lines of medicine that the NHP GMP supported.

Rotational testing

The rotational testing section mentioned, “ensure all tests on the product’s specifications are done at least once every 3 lots or once a year if fewer than 3 lots are manufactured or imported annually”. In addition, the site license application and renewal rule suggested that GMP supporting evidence shall have a date that is within 12 months of the application date. I believe this point could also be elaborated further in this section.  The important reason is that many small and medium-sized importers and manufacturers do not manufacture or import a product every 12 months due to the limited size of the Canadian market.  The update can guide the evidence needed to support GMP compliance, could a license holder substitute a different product?  What mechanism can the site license holder communicate with NNHPD that the product evidence they seek may not be available in 12 months’ renewal time? Some guidance here could save a lot of unnecessary communication between the license holder and NNHPD officers.

Another point the GMP guide can clarify is in raw ingredient and product testing. I have seen the Quality of Natural Health Products Guidespecifically mention that if a solvent or chemical contaminant has not been used, it is exempted from testing (sections 3.3.3 and 3.3.7). I hope this can be clarified or elaborated further in this section of the GMP guide on how one can provide evidence to support that.  This can help manufacturers and importers focus on what they must do and not duplicate efforts.

Quality assurance

The guide mentioned a qualified QAP but did not provide specifics. It is especially important to include the language requirement just like you have requirements on translations. On top of that, it should have experience and training requirements (passing a full course in GMP). After 20 years of NHP regulation, we should have a guideline on QAP requirements.

Training clarity also needs more specific guidance because no specific NHP training courses are being certified by the NNHPD. Training should be GMP-based and have some form of validation (quiz) of the training even if they may not be specific to NHP. One effective training portal for food safety is the PHAC Training Portal, the NNHPD may consider developing courses in the portal to help spread the inclusive nature of the NHP GMP knowledge.

Prohibition

Today, there are many privately owned websites and online sales platforms that support the cross-border shipping and sales of Natural Health products. I hope the guide could encourage the reporting of these unlicensed products that do not have Canadian authorization and NPN.  A brief description or referral of the reporting process to the enforcement branch will be very helpful to the industry in this section.

Stability section 52 -Assigning expiry date

Further guidance can be provided on how to assign the initial expiry date. From our experience of providing site license evidence, completed long-term stability of a similar product and the manufacturer’s experience coupled with close market monitoring would be acceptable evidence.  This is especially true for Traditional medicine – where they had been manufactured for more than 25 years.

Records

Please clarify the subsection “Translating records into English or French” on the support required for an uncertified translator. When an NHP GMP document is translated by an uncertified translator using an affidavit, it is the affidavit on the translation qualification of the uncertified translator that is required. Please also allow the submission of the affidavit once for multiple records and different submissions. This eliminates the need to submit the affidavit in every submission.  

Regarding GMP records of MRA sites, please clarify if NNHPD will recognize an MRA manufacturer’s Batch Certificate if the GMP inspections of the manufacturer are conducted outside of their respective jurisdictions. If not, is there a plan to do that soon like DIN manufacturers?

Pest risk

For importers who handle finished products alone, there is a difference between rats and insects. I hope the guide can distinguish so that it becomes clear on the severity of the risks.

General

Understand that the guide is written to be as general as possible. As you have done for Homeopathic medicines, discussing and providing examples that are relevant to product licensing e.g. by product class, compendial products, and traditional products will help assessment officers when they review evidence from specific products. It will guide the assessment officer to choose the right product evidence to review and for a licensee to provide the exact evidence that supports their GMP activities. 

Site and product license evidence Information Sharing

The site license assessment office seemed to have an inconsistent understanding of why a product has a majority of the medicinal ingredients by input is not necessarily a higher risk. The product is licensed with the same evidence provided to the product license office and approved with an NPN like another product. In addition, once a product is licensed, NNHPD should have all the evidence on the Finished Product Specifications (FPS) that were approved. The evidence that supports ingredients by input should be available to the site license assessment team for reference. I hope the GMP practice guide can suggest a way of information sharing (by providing the submission no. or file number of the product) to allow the site license assessment officer to view them. If there is clearer or further guidance on products (i.e. Traditional) with a majority of ingredients by input, we would like to see them.

Expert Review Contribution: Preventive Healthcare Guidelines

December 2024 position on Canadian Task Force om Preventive Health Care

Background

Thank you for setting up the consultation on Preventive Health Care. We believe it is a topic we are responsible for contributing to the greater good of Canadian health care. Before answering the three questions on the consultation, I would like to provide our background, understanding of the Canadian Preventive Health Care situation, and our approaches. Cyctek Inc. is an importer and consulting company on Natural Health Products (NHPs). In the past 20 years, we worked with Health Canada and the Complementary and Alternative Medicine[1] industry to promote the use of Natural Health Products (NHP) and alternate health services to improve the health of Canadians. The 2005 Health Indicator report[2] found that the city of Richmond in British Columbia had the highest life expectance in Canada due to their belief and practice in using Complementary and Alternative Medicine.

We believe Preventive Health Care is more than screening. Our recommendation to the Task Force is to provide guidelines to involve individuals in healthy living and health management as part of Preventive Health Care. From the two references quoted in the footnote above, we know that 80% of Canadians use Complementary and Alternative Medicine which is the main reason for the high life expectancy of the residents of Richmond.  Our feedback below is based on the two key results above plus our experience in Complementary and Alternative Medicine for the past 20 years.   

Key questions for discussion

1. Which practices should be maintained or what changes to the Task Force governance or structure could further support transparency, accountability, independence and leadership, towards scientifically rigorous, timely, agile and inclusive guidelines?

The Task Force is doing a great job of providing important guidelines on many critical diseases.  There is a need to enhance Canadians’ engagement in deciding what guidelines to add or improve, what additional content to include, and measures for the effectiveness of the guidelines.  The governance and structure must be adjusted to Canadians’ health concerns and practices. This will help the Task Force achieve transparency, accountability, independence and leadership, toward scientifically rigorous, timely, agile and inclusive guidelines. It could start by reviewing surveys and statistics on Canadian healthy living practices. One example is the “Self Care Framework”[3] promoted by Health Canada. The task Force could recognize the Self Care Framework as one key contributing factor to Preventive Health Care and enhance the guideline by adding additional relevant content. If we use the Diabetes, Type 2 guideline as an example, currently it primarily focuses on screening. It would be helpful to include guidelines on what individuals could do with “high-risk” screening results. There is no difference from Public Health asking Canadians to wear a face mask during the last pandemic, one needs individuals’ involvement to make themselves and others healthier.  Involving potential patients in preventive care beyond screening is a vital component of Preventive Health Care.  The Self Care Framework includes and empowers individuals to get involved in maintaining good health, when done correctly, which is the best way to prevent the onset and mitigate symptoms of diseases.  

According to the Fraser Institute survey, Complementary and Alternative Medicine is not one single thing, it includes 26 different therapies (table 17). Furthermore, some therapies e.g. Herbal therapies or Folk remedies are composed of Indigenous, Traditional Chinese, Swiss and Ayurveda traditional Medicines etc. We recommend the Canadian Task Force take the leadership to include elements of the Complementary and Alternative Medicines in the relevant guidance. The Task Force governance or structure should reflect the survey results; for example, a governance body or structure should include knowledge and experience from the practice of Complementary and Alternative Medicines. Ideally, the individuals of the group that develops guidelines should have cross-functional knowledge and experience on multiple healthcare topics. This approach will allow the Task Force to support transparency, leadership and inclusive guidelines, and is a closer representation of the Canadian society. On accountability and leadership, we see that it is important to measure the benefits of a Preventive Health Care guideline and how it compares with the initial purpose of creating the guideline. The benefit should be measurable and relevant to the targeted healthcare systems. The benefits should be monitored, the results should be used for change management of the specific guidelines. Managing the change according to follow-up surveys and statistics will add timeliness, agility and efficiency to the guidelines.

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[1] https://www.fraserinstitute.org/studies/complementary-and-alternative-medicine-use-and-public-attitudes-1997-2006-and-2016

[2] https://publications.gc.ca/collections/Collection/H115-16-2005E.pdf

[3] https://www.canada.ca/en/health-canada/topics/self-care-products.html

Better regulatory actions on Natural Health Products, not more

August 2023 Position on Health Canada and NNHPD proposed changes to NHPs

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[1] The Star – between 2000 and 2011, an average of 68 Canadians died each year because of acetaminophen

[2] 150 Americans Die Each Year from Tylenol’s Most Active Ingredient

August 2022 Cyctek Inc. presented in the 1st International Conference on Traditional Chines Medicine Tele-Healthcare

Topic: Canadian Traditional Chinese Medicine Regulatory Framework as a component of Tele-healthcare

November 2022 – Cyctek Presented in the 3rd Western China International Sourcing Fair

Topic in Mandarin: 加拿大中药法规概述 Traditional Chinese Medicine Regulatory environment in Canada

Cyctek Inc. signed exclusive product marketing agreement with North America Health on the Y2X Nature Health Products