Human Health
Regulatory Strategy Development
Pda will perform an assessment of the various human health regulatory pathways with determination of the preferred regulatory approach to expedite product development and approval. This includes the creative shaping of the regulatory processes and data needs via the development of regulatory positioning papers, the preparation for and conduct of regulatory pre-submission meetings, and, other pertinent regulatory planning activities.
Natural Health Products and Ingredients
Natural Health Products (NHPs) are regulated by Health Canada's Natural and Non-Prescription Health Products Directorate (NNHPD). NHPs, also referred to as “complementary and alternative medicines” include:
- Vitamins and Minerals
- Herbal Remedies
- Homeopathic Medicines
- Traditional Chinese and Ayurvedic medicines
- Probiotics
- Amino acids
- Essential Fatty Acids
To be legally marketed and sold in Canada, NHPs must have a Product License and a Natural Product Number (NPN) assigned by Health Canada. Pda has extensive experience with the registration of NHPs in Canada and can assist companies with the following activities:
- Pre-Submission Meetings with the NNHPD
- Product Development Plans that satisfy business and regulatory needs
- Requests for amendments to the NHP Ingredients Database
Foods
Foods are regulated by three complementary Canadian regulatory bodies: Health Canada, the Canadian Food Inspection Agency (CFIA), and, Agriculture and Agri-Food Canada (AAFC). By definition, a food includes any item manufactured, sold or represented for use as a food or drink, and any ingredients that may be mixed with food. Generally, there are no mandatory requirements for the pre-market licensing/ notification of foods in Canada, with a few exceptions.
Pre-market approval from Health Canada is required for the following types of foods to be legally sold in Canada:
- Infant formulas
- Novel foods that are not currently on the List of Accepted Novel Foods
- Novel fibres
- New food additives that are not currently on the List of Permitted Food Additives, and new uses for an existing food additive
- Foods accompanied by Health Claims that are not currently approved by Health Canada
Paul Dick & Associates Ltd. can assist companies with the following activities:
- Pre-Submission Meetings
- Novel Food Notification Submissions
- Food Additive Submissions
- Health Claim Submissions
