Notice to: Stakeholders of clinical trials for biologic-type natural health products

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

October 5th, 2012

Dear Stakeholder:

This Notice serves to inform stakeholders of the second phase of a pilot plan to streamline clinical trial application review activities within the Natural Health Products Directorate (NHPD). Beginning October 5th, 2012, the NHPD will no longer review Clinical Trial Applications (CTAs) for biologic-type natural health products (NHPs), such as hormones and probiotics, where the use of the product is not appropriate for self-care (please see attachment for guidance).

On August 1, 2012, a notice informed stakeholders of the first phase of this pilot plan by transitioning all NHP CTAs, with the exception of probiotic and hormone products, which contain primary indications not appropriate for self-care use to the Therapeutic Products Directorate (TPD). This second phase will begin the transition of these probiotic and hormone NHPs, as well as other biologic-type NHPs which are not appropriate for self-care to the Biologics and Genetic Therapies Directorate (BGTD). All other NHP CTAs, for which the proposed primary indications are appropriate for self-care use, will continue to be reviewed by the NHPD.

All amendments submitted to the NHPD for previously approved CTAs for biologic-type natural health products (NHPs), where the use of the product in the clinical trial is not appropriate for self-care, will be also directed to BGTD.

As was outlined in the previous notice regarding this pilot plan, CTA Information Request Notices (IRNs) will require a response within a target of two business days. Additionally, applicants will be required to provide all CTA documents in an acceptable electronic format similar to the Notice of Electronic Specifications for CTAs and CTA-As for Clinical Trial Sponsors.

Pre-submission consultations are encouraged by the NHPD, the TPD and the BGTD.

Please refer to the attached guide to determine whether a CTA will be reviewed by the BGTD (see Appendix 1). Until further notice, please continue to send all applications and amendments to the NHPD, from where they will be routed to the appropriate Directorate. Health Canada will notify the sponsor as to which Directorate will review the file.

Please continue to our "Contact Us" page for courier service delivery of CTAs.

Appendix 1

Guidance outlining factors considered in determining if a NHP Clinical Trial is to be reviewed by the NHPD (use that is appropriate for self-care) or by the TPD or the BGTD (not appropriate for self-care use)

As per the previous notice to stakeholders sent August 1, 2012, the determination of whether or not a proposed clinical trial includes a use that is appropriate for self-care will be made by Health Canada using the factors below. These factors are similar to the criteria used to determine whether a drug should be sold only by prescription, i.e., for conditions of use that are not appropriate for self-care. Please note that these factors may be revised in the near future. Stakeholders will be notified accordingly.

STEP 1: Determination of self-care status

The applicability of one or more of the following factors with regard to the intended conditions of use or the characteristics of the product would trigger the decision that a product is not best suited for self-care use.

  1. individualized instructions and/or direct practitioner supervision, adjunctive therapy with Scheduled drugs or routine laboratory monitoring are anticipated to be required;
  2. there is a narrow margin of safety between the therapeutic and toxic doses of the NHPs to be tested, especially in populations such as geriatrics, children and pregnant or nursing mothers;
  3. are potential or known undesirable or severe side effects of the NHPs to be tested at normal therapeutic dosage levels;
  4. the NHPs to be tested are known by experimental data to induce toxicity in animals but have not been in clinical use long enough to establish the pattern or frequency of long-term toxic effects in humans;
  5. the primary indication is to treat a serious disease easily misdiagnosed by the public;
  6. the use of the NHPs to be tested may mask other ailments;
  7. the NHPs to be tested have contributed to, or are likely to contribute to, the development of resistant strains of micro-organisms due to the presence of antimicrobial substances;
  8. the NHPs to be tested possess a dependence or abuse potential that is likely to lead to harmful non-medical use;
  9. the NHPs to be tested possess a high level of risk relative to expected benefits; or
  10. the NHPs to be tested have a therapeutic effect based on recently elucidated pharmacological concepts, the consequences of which have not been established.

STEP 2: Determination of appropriate Directorate

  1. If the NHP Clinical Trial Application (CTA) does not meet any of the factors above, the CTA will be reviewed by the NHPD.
  2. If the NHP CTA meets one or more of the factors above, the CTA will be reviewed by the TPD or the BGTD as appropriate.
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