Notice to: Stakeholders of clinical trials for natural health products

Dear stakeholder:

This notice serves to remind stakeholders that as of 2021, all clinical trial applications (CTAs) and amendments to CTAs (CTA-As) for authorized natural health products (NHPs) or those seeking authorization under the Natural Health Products Regulations are reviewed by the Natural and Non-prescription Health Products Directorate (NNHPD), rather than the Pharmaceutical Drugs Directorate (PDD).

Please send all applications and amendments for NHP CTA and CTA-As electronically.

• If you are a registered Trading Partner, these applications can be submitted through your 'New Applications' conversation within epost Connect.
• If you are not a registered Trading Partner, these applications can be submitted directly via email to: nhpd-cta-dec-dpsn@hc-sc.gc.ca.

For applications employing products across different product lines (e.g., drugs, medical devices, and/or NHPs), the applicant/sponsor must comply with each applicable set of Regulations.

Further to this, a clinical trial employing both an investigational NHP and an investigational drug would need to receive a Notice of Authorization (NOA) and a No Objection Letter (NOL), respectively, and ensure compliance with both the Natural Health Products Regulations and the Food and Drug Regulations (FDR).

There is no 'lead bureau' for such a study; rather, a CTA should be submitted to the PDD (for pharmaceuticals) or the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) for biologics and/or radiopharmaceuticals and a NHPCTA should be submitted to the NNHPD. The sponsor would need to have both a NOL and NOA prior to commencing the study in Canada.

For any inquiries about this Notice, please contact NNHPD at nhpd-cta-dec-dpsn@hc-sc.gc.ca.