Regulatory Affairs

Regulatory Strategy Development

PDA will perform an assessment of the various animal and 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. 

Animal Health

Veterinary Drugs

Veterinary drugs are pharmaceutical products intended to prevent, treat, diagnose or mitigate a specific disease or condition in animals. Veterinary drugs are regulated by Health Canada’s Veterinary Drugs Directorate (VDD) under the Food and Drugs Act and Regulations. Veterinary drugs must be safe and efficacious for the target species when used as intended, safe for humans that may come in contact with the product, and, safe for the environment. There are a long list of requirements for veterinary drug submissions in Canada, and PDA is well-versed in these requirements.


PDA can assist drug manufacturers with their regulatory dossiers to ensure the dossier is complete. Incomplete dossiers will add significant time onto the regulatory review process and could hinder market authorization in Canada. PDA is also highly skilled in pre-submission consultations with the VDD and will work with companies to prepare for the meetings and optimally position the company and the product during the meeting. Pre-submission meetings are an excellent opportunity to introduce the company and product to the regulators, meet the regulators who will be responsible for the review of the submission, and, pose questions to the regulators regarding the product submission. 

Veterinary Health Products

To be legally marketed and sold in Canada, companion and food animal health products must obtain a Notification Number (NN) from the Veterinary Drugs Directorate (VDD) via the Veterinary Health Products (VHP) Notification Program. The VHP Program replaced the previous Low-Risk Veterinary Health Products (LRVHP) Interim Notification Pilot Program (INPP) as of November 13th, 2017. 


PDA was instrumental in the development of the initial LRVHP program and has worked with numerous companies to obtain Admissible Substance status for their ingredients, and Notification Numbers for their products. 

Veterinary Biologics

In Canada, animal vaccines, infectious disease diagnostic tests, and antibody products are classified as "veterinary biologics," and are regulated by the Canadian Food Inspection Agency (CFIA), under the Health of Animals Act and the Health of Animals Regulations. There are specific requirements for quality, safety and efficacy that must be satisfied before market authorization can be obtained for these products. PDA can assist vaccine manufacturers with pre-submission meetings, assembling the regulatory dossier, and regulatory submissions. 

Feeds

Feeds and feed ingredients intended for food animals/ livestock are regulated by the Canadian Food Inspection Agency (CFIA) under the Feeds Act and Regulations. Feeds include, but are not limited to: amino acids, antioxidants, carbohydrates, condiments, enzymes, fats, minerals, non-protein nitrogen products, proteins or vitamins, or pelletizing, colouring, foaming or flavouring agents. For a feed/ feed ingredient to be approved for use in Canada, it must be safe for the target species, safe for humans consuming the animal products, safe for the environment, and, efficacious for its intended purpose. 


PDA has significant expertise in the regulation of feeds in Canada and was instrumental in the proposed modernization of the Feeds Regulations. PDA can assist feed manufacturers with pre-submission meetings, assembling the regulatory dossier, and regulatory submissions. 

Feed Additives for the European Market

PDA is well versed in the European regulation of feed additives and can assist companies that wish to enter the European market in navigating the European regulatory requirements. PDA offers the following services to ensure a smooth regulatory review and approval process:


  • Gap Analysis: Complete review of product data package to identify information gaps that will be required to satisfy European regulatory requirements.
  • Pre-Submission Meeting with DG Sanco: A very important initial step to product registration; PDA will prepare all meeting pre-reads, coordinate the meeting, attend the meeting (with the company/ sponsor), moderate the meeting, and record detailed meeting minutes.
  • Regulatory Submission: PDA will manage and assemble all aspects of the European regulatory submission, including submissions to the European Commission, the European Union Reference Laboratory, and the European Food Safety Authority. 

Human Health

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