Most Natural Health Product licenses can be obtained through product license application submissions providing safety and efficacy data based on the medicinal ingredients in the formula submitted.
Companies may, however, have a human clinical trial conducted for several reasons:
- To demonstrate an ingredient at different dosage levels than those indicated in peer reviewed journals;
- When no studies have been previously conducted, published or unpublished;
- When new conditions not captured on the product label are seeking evidence for support.
Clinical studies can vary in complexity, from a meta-analysis of studies conducted to a multi-center, double-blind, placebo-controlled human clinical trial.
For such a study to be acceptable for a natural health product, it is advisable to follow the protocol for clinical trials as outlined by the NHPD. 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.
Quality Smart Solutions can help guide you to determine what type of clinical trial should be conducted and, if required, prepare a Clinical Trials Application (CTA) to submit to the Natural Health Products Directorate. Our Clinical Trial Solution includes:
Guidance on the type of study to be conducted Preparation of the CTA Attendance with you at a pre-CTA meeting in Ottawa with NHPD officials. If desired, connect you with one of our clinical trials providers who can conduct the study on your behalf.