Clinical trials : Natural health products

For the definition of a Natural Health Product (NHP), and for the list of included NHP substances for which Health Canada approval must be sought and the list of excluded NHP substances for which Health Canada approval is not required, please consult the Natural Health Products Regulations and the Natural Health Products Compliance Guide, which are available at the web site referenced below.

Health Canada Review

A Clinical Trial Application (CTA) must be filed with Health Canada prior to the initiation of a clinical trial in Canada.

The legal requirements for NHP clinical trials are found in the NHP Regulations which are administered by the Natural Health Products Directorate (NHPD). This Directorate of Health Canada is responsible for granting or denying authorization for these trials.

Not all clinical trials of natural health products require authorization from Health Canada.

To determine whether your trial requires authorization or not, please consult the NHP Regulations and the Clinical Trials for Natural Health Products guidance document, which are available at the web site referenced below.

All necessary forms, information and guidance documents are available at:

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html

Of particular importance is the guidance document entitled Clinical Trials For Natural Health Products.

In order to obtain approval from the NHPD, a Clinical Trial Application (CTA) must be submitted to the NHPD and authorized by the NHPD.

If there is any uncertainty as to whether Health Canada approval is required, the investigator is encouraged to contact Health Canada, Health Products & Food Branch - Natural Health Products Directorate

 

University of Ottawa Ethics Review

Whether your clinical trial requires authorization or not from Health Canada, you must submit an ethics application to either the Health Sciences and Science Research Ethics Board (REB) of the University of Ottawa or, as appropriate, to the REB of one of the University of Ottawa’s affiliated hospitals.

Approval from the Research Ethics Board of the Qualified Investigator’s hospital must be obtained concurrently with or prior to submission to the Health Sciences and Science Research Ethics Board (REB) of the University of Ottawa. The hospital REB reviewing the protocol must include “member knowledgeable in complementary or alternative health care.” If the Qualified Investigator is not associated with one of the University of Ottawa’s affiliated hospitals or if that REB does not include the required membership, please contact the Ethics Office at the address indicated below.

The REB reviewing the protocol must include “member knowledgeable in complementary or alternative health care.”

For applicable studies:

  • The Clinical Trial Application for Health Canada approval must be submitted to Health Canada before submitting an application for ethical review to the appropriate Research Ethics Board (REB) at the University of Ottawa or one of the University of Ottawa’s affiliated hospitals;
  • A copy of the Clinical Trial Application to Health Canada must be included in the application to either the Health Sciences and Science Research Ethics Board (REB) of the University of Ottawa or, as appropriate, to the REB of one of the University of Ottawa’s affiliated hospitals;
  • The REB must receive a copy of the Health Canada authorization prior to the REB releasing the final certificate of approval.

For further information on the University of Ottawa Ethics Review process, please contact:

Ethics Office 
(613) 562-5841
ethics@uOttawa.ca

Important Information for Investigators

All clinical investigators must be familiar with the NHP Regulations. The regulations were published in Canada Gazette, Part II, on June 18, 2003 and are available at the web site referenced above.

There must be ONE Qualified Investigator at each clinical trial site who is responsible for, among other things, the safety of the clinical trial subjects. A Qualified Investigator is a licensed physician or dentist who is entitled to provide health care under the laws of the province where the clinical trial is located (see section 63 of the NHP Regulations). A Qualified Investigator may oversee more than one site.

The Qualified Investigator must sign an undertaking that he/she will conduct the trial according to Good Clinical Practices. Please see the “Qualified Investigator Undertaking” form available at the web site referenced above.

Therapeutic Products Directorate : Certain clinical trials may have to be submitted to the Therapeutic Products Directorate (TPD) rather than the NHPD. For more information, please refer to Health Canada’s guidance documents.

Record keeping : Health Canada requires that all clinical trial records be maintained for a period of 25 years. More information is provided in the Clinical Trials for Natural Health Products Guidance Document mentioned above.

Turnaround period : Health Canada’s turnaround period is approximately 30 days but can be longer.

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