Clinical Trial Application for NHPs (CTA)

Partner with us to understand the type of clinical trial that should be conducted for your NHPs and prepare the Clinical Trials Application (CTA) followed by submitting it to the NHPD.

Why Clinical Trials for NHPs are Important

Reasons for conducting clinical trials for NHPs are many. However, one of the key reasons is to demonstrate an ingredient at various dosage levels rather than those shown in peer-reviewed journals, especially when:

  • No studies previous have been published, conducted or unpublished;
  • New conditions not captured on the product label are looking for evidence for support.

Overview of Clinical Trial Studies

Clinical studies can vary in complexity. It includes 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, following the protocol for clinical trials as outlined by the NHPD is necessary. The clinical trial format should 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 the 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 drug 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 Application for NHPs Should Include?

The Clinical Trial Application includes a protocol, detailing the objectives, methods, benefits, risks and conditions for the trial to function. Besides all these, the CTA should also include:

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

Get Expert Help for Clinical Trial for NHPs

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 Trials Application (CTA) to submit to the Natural Health Products Directorate (NHPD). Besides, our Clinical Trial Solution also includes Guidance on the Preparation of the CTA Attendance with you at a pre-CTA meeting in Ottawa with NHPD officials. If required, we will connect you with our clinical trial experts who will conduct the study on your behalf.

Need Support for Your Clinical Trial in Canada?

If you need support for your Clinical Trial for NHPs, fill the below form. We will respond to you soon.

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