The Notice communicates Health Canada’s position on the classification and regulation of topical products at the cosmetic-drug interface that contain human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media. It outlines the considerations applied in determining whether a topical product containing one or more of these substances is classified and regulated as a drug product or cosmetic product. It is intended to provide information to regulated parties on compliance with the Food and Drugs Act and its regulations, and is intended to be used in conjunction with other existing guidance documents and policies.
