Notice to: Stakeholders of clinical trials for 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.

August 1st, 2012

Dear stakeholder:

This notice serves to inform stakeholders of a pilot plan to streamline clinical trial application review activities within the Natural Health Products Directorate (NHPD). Beginning August 1, 2012, the NHPD will no longer review clinical trial applications (CTAs) for natural health products (NHPs) where the use of the product is not appropriate for self-care (please see attachment for guidance). This will begin as a phased approach beginning with those applications that could be reviewed by the Therapeutic Products Directorate (TPD). Other product lines, such as biologics, could be included in the future.

CTAs for which the proposed primary indications are appropriate for self care use will continue to be reviewed by the NHPD. With the exception of probiotic and hormone products, all NHP CTAs which contain primary indications not appropriate for self-care use will be reviewed by TPD. Amendments to CTAs already approved by NHPD for CTAs for which the proposed primary indications are not appropriate for self care use will also be directed to TPD. NHPD will continue to provide advice as appropriate.

With the exception of some changes described below, a similar approach will be maintained by TPD in the review of NHP CTAs. The same NHPD application forms will continue to be used.

Changes taking place/directions for the path forward

In keeping with the effort to improve the efficiency and timing of reviews, the Therapeutic Products Directorate (TPD) and the Natural Health Products Directorate (NHPD) will require clinical trial applications (CTA) Information Request Notices (IRNs) to be responded to within a target of 2 business days. This is a significant decrease from the 30 days that was previously allowed by NHPD. Although there is flexibility in providing extensions to the due date for responses to IRNs, applicants must ensure that their applications are comprehensive and complete prior to submission to Health Canada. Pre-submission consultations are encouraged and both Directorates will provide assistance where required.

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.

Please consult the attached guide to determine whether a CTA will be reviewed by NHPD or by TPD. However, until further notice, please send all applications and amendments to NHPD who will route them to the appropriate Directorate. Health Canada will notify the sponsor as to which Directorate will review the file.

Please continue to use the following address for courier service delivery of CTAs:

Natural and Non-prescription Health Products Directorate
Attn: Submission Administration Unit
250 Lanark Avenue AL 2002B
Ottawa, Ontario
K1A 0K9 (Canada Post delivery including Xpress Post)
K1Z 1G4 (Courier service excluding Xpress Post)

Should further changes or clarifications be necessary to the plan to streamline the review of NHP CTAs as described above, a subsequent Notice to Stakeholders will be published.

For any inquiries about this Notice please contact hc.nnhpd-dpsnso.sc@canada.ca.

Appendix 1

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

Until further notice, 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. there 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 NHPD.
  2. If the NHP CTA meets one or more of the factors above, the CTA will be reviewed by TPD.
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