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.
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:
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.
The Clinical Trial Application has three modules.
Module 1 of CTA contains clinical and administrative information about the proposed trial.
Module 2 comprises quality information about the health product to be used in the proposed trial.
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:
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. Clinical trial applications come with a lot of questions, and there is plenty of room for misunderstandings.
Before submitting a clinical trial application, it is important to ensure that you have collected and organized all the information and documentation necessary for your application. This includes obtaining and documenting patient consents and collecting essential research information, such as background materials, study protocols, scientific merit assessments, data analyses, etc. Additionally, you should obtain professional advice on your project, such as input from applicable experts or industry groups. In order to protect the safety of patients by ensuring compliance with applicable laws and regulations, you must demonstrate a high level of detail when providing this information in your application.
As part of your clinical trial application, you must be sure to identify and research the relevant regulatory requirements associated with conducting a clinical trial. This includes determining whether any special permissions are needed and understanding any regulations that apply to the study design, procedure, or sample size. Furthermore, you should make sure that all data collected complies with applicable laws and regulations in the jurisdiction where the research is located. Additionally, you should review any guidelines issued by international or national regulatory agencies related to approving clinical trial applications.
Before submitting your clinical trial application, you must prepare an application protocol document, which outlines the research aims and goals of your investigation. This document should provide detailed information about the study design, planned procedures, sample size, and other essential elements related to the proposed clinical trial. It is important to ensure that this document accurately reflects all of the relevant regulatory requirements applicable to conducting a clinical trial in your jurisdiction. Additionally, make sure that the document includes sufficient detail concerning safety considerations, ethical principles, and data protection regulations so that the review board can properly assess your application.
Once you have developed the protocol document, it is important to complete a detailed plan for the clinical trial design. This should include a study diagram showing all relevant steps in the investigation and outcome measurements, as well as other materials such as consent forms for participants and patient information sheets. In addition, provide proof of the medical review process if applicable, documentation regarding risk assessment and management measures that have been taken, appropriate research ethics committee (REC) approvals, and an SOP concerning data collection and analysis. By submitting these materials along with your application, you are giving reviewers a comprehensive overview of your planned clinical trial that they can use to assess its validity.
One of the most important factors for a successful clinical trial application is selecting the right sites to participate in the study. When making this decision, it is important to consider factors such as patient population and geographic location, access to medical care, and any regional regulatory requirements that must be met. Additionally, contact with potential participants should begin early in the process before finalizing the research design. This will help ensure that recruitment targets can be met during the study period and that any ethical concerns can be addressed prior to submission of your application.
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:
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 Application (CTA) Form
If you need support with your NHP Clinical Trial, fill in the form below:
