Consultation: Classification of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media

The purpose of this consultation is to communicate to industry, practitioners, and the public about Health Canada's intended approach to 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

We are inviting comments, along with any other relevant information for consideration, from:

• manufacturers
• distributors
• other stakeholders

Read the notice.

Join in: How to participate

Review the notice. Send an email to the Therapeutic Products Classification Committee Secretariat at drug.device.classification-drogue.instrument@hc-sc.gc.ca with your input or comments.

Who is the focus of this consultation

We will engage with:

• manufacturers and distributors of topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media
• industry and academics conducting research on topical products containing human-derived exosomes, human extracellular vesicles, and/or human cell-conditioned media
• health care practitioners
• interested members of the public

Key questions for discussion

Health Canada is seeking input on the proposed approach to the classification and regulation of topical products that contain:

• human-derived exosomes
• human extracellular vesicles and/or
• human cell-conditioned media

This intended approach is based on available evidence to date. The notice 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. It is also intended to be used in conjunction with other existing guidance documents and policies.

Related information

• Guidance Document: Classification of Products at the Cosmetic-Drug Interface

Contact us

Therapeutic Products Classification Committee Secretariat
drug.device.classification-drogue.instrument@hc-sc.gc.ca