Veterinary Regulatory Affairs
Regulatory Strategy Development
Pda will perform an assessment of the various veterinary 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.
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.
