Clinical Trial Application for NHPs (CTA)

Partner with us to understand the type of clinical trial that should be conducted for your Natural Health Products (NHPs). We can assist in preparing the Clinical Trial Application (CTA) and help submit the complete dossier to the NNHPD.

Why Clinical Trials for NHPs are Important

There are many situations where clinical trials for NHPs

may need to be conducted. One of the key reasons to conduct a clinical trial is to demonstrate an ingredient/product is safe and efficacious at various dosage levels, especially when:

  • No previous studies have been conducted or published
  • New conditions not captured on the product label are seeking evidence for support
Clinical Trial Application
nhp clinical trial application form

Overview of Clinical Trial Studies

Clinical studies can vary in complexity. They can include a meta-analysis of studies that leads to a multi-center, double-blind, placebo-controlled human clinical trial. For such a study to be acceptable for a natural health product, the protocol for clinical trials as outlined by the NNHPD must be followed. The clinical trial format should also follow the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines.

Clinical Trial Application

A Clinical Trial Application (CTA) for Natural Health Products is a submission to the competent Regulatory Authority for obtaining approval to conduct a clinical trial in Canada. It is an application with relevant information on investigational medicinal products. The application is submitted in the Common Technical Document (CTD) format. The objective of a CTA is to provide health authorities with all essential details about the clinical trial in order to obtain product approval.

Clinical Trial Application Modules

The Clinical Trial Application has three modules.

Module 1

Module 1 of CTA contains clinical and administrative information about the proposed trial.

Module 2

Module 2 comprises quality information about the health product to be used in the proposed trial.

Module 3

Module 3 of the Clinical Trial Application includes additional supporting quality information.

What Clinical Trial Applications for NHPs Should Include

A Clinical Trial Application must include a protocol detailing the objectives, methods, benefits, risks, and conditions for the trial to function. Besides this information,, the CTA should also include:

  • Clinical Trial Site Information Form
  • Research Ethics Board Attestation
  • Qualified Investigator Undertaking
  • Clinical Trial Application (CTA) Form
Clinical Trial Application

Get Expert Help with NHP Clinical Trial Applications

At Quality Smart Solutions, our specialists will guide you to determine the type of clinical trial that should be conducted as well as prepare a Clinical Trial Application (CTA) to submit to the Natural and Non-Prescription Health Products Directorate (NNHPD). Our Clinical Trial Solution also includes guidance on the pre-CTA meeting with NNHPD officials. 

Frequently Asked Questions - Clinical Trial Applications

There are many situations where clinical trials for NHPs

may need to be conducted. One of the key reasons to conduct a clinical trial is to demonstrate an ingredient/product is safe and efficacious at various dosage levels, especially when:

  • No previous studies have been conducted or published
  • New conditions not captured on the product label are seeking evidence for support

Clinical studies can vary in complexity. They can include a meta-analysis of studies that leads to a multi-center, double-blind, placebo-controlled human clinical trial. For such a study to be acceptable for a natural health product, the protocol for clinical trials as outlined by the NNHPD must be followed. The clinical trial format should also follow the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and Good Clinical Practice (GCP) guidelines.

A Clinical Trial Application (CTA) for Natural Health Products is a submission to the competent Regulatory Authority for obtaining approval to conduct a clinical trial in Canada. It is an application with relevant information on investigational medicinal products. The application is submitted in the Common Technical Document (CTD) format. The objective of a CTA is to provide health authorities with all essential details about the clinical trial in order to obtain product approval.

Module 1: Module 1 of CTA contains clinical and administrative information about the proposed trial

Module 2: Module 2 comprises quality information about the health product to be used in the proposed trial.​

Module 3: Module 3 of the Clinical Trial Application includes additional supporting quality information.

A Clinical Trial Application must include a protocol detailing the objectives, methods, benefits, risks, and conditions for the trial to function. Besides this information,, the CTA should also include:

  • Clinical Trial Site Information Form
  • Research Ethics Board Attestation
  • Qualified Investigator Undertaking

Clinical Trial Application (CTA) Form

Need Support for Your Clinical Trial in Canada?

If you need support with your NHP Clinical Trial, fill in the form below:

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